All Morsani College of Medicine clinical trial entries below were provided by the USF Health Office of Clinical Research:

Title: SafeHeal Colovac Colorectal Anastomosis Protection Device Evaluation (SAFE-2) Pivotal Study A Study to Evaluate the Safety and Effectiveness of the Colovac Colorectal Anastomosis Protection Device
Principal investigator: Marcet, Jorge
Department: Surgery
Sponsor: SafeHeal
Opening date: 1/14/2022

Title: A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of the Efficacy and Safety of Inhaled Treprostinil in Subjects with Idiopathic Pulmonary Fibrosis
Phase: III
Principal investigator: Bandyopadhyay, Debabrata
Department: Internal Medicine
Sponsor: United Therapeutics
Opening date: 1/10/2022

Title: INHALE 1: A 26-week Primary Treatment Phase, with 26-week Extension, Open-label, Randomized Clinical Trial Evaluating the Efficacy and Safety of Afrezza® Versus Rapid-acting Insulin Analog Injections, Both in Combination with a Basal Insulin, in Pediatric Subjects with Type 1 or Type 2 Diabetes Mellitus
Phase: III
Principal investigator: Rodriguez, Henry
Department: Pediatrics
Sponsor: MannKind Corp.
Opening date: 1/7/2022

Title: A 2-Part, 2-Arm, Phase 2, Randomized, Double-Blind, Placebo-Controlled Study on the Safety and Efficacy of Niclosamide in Patients with COVID-19 with Gastrointestinal Infection
Phase: II
Principal investigator: Eranki, Ambika
Department: Internal Medicine
Sponsor: First Wave BioPharma, Inc.
Opening date: 1/7/2022

Title: A Phase 3, 2-Part, Open-Label, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of Liposomal Treprostinil Inhalation Suspension (L606) in Subjects With Pulmonary Arterial Hypertension Previously Stabilized on Inhaled Treprostinil Products
Phase: III
Principal investigator: Restrepo-Jaramillo, Ricardo
Department: Internal Medicine
Sponsor: Pharmosa Biopharm
Opening date: 1/6/2022

Title: A Multi-Center, Prospective, Randomized Controlled Trial Comparing the Safety and Effectiveness of prodisc® C SK and prodisc® C Vivo to Mobi-C® Cervical Disc in the Treatment of Two-Level Symptomatic Cervical Disc Disease (SCDD)
Phase: Device
Principal investigator: Hayman, Erik
Department: Neurosurgery
Sponsor: Centinel Spine
Opening date: 1/6/2022

Title: Envisia® Single Tube Sample Collection
Phase:  N/A (test)
Principal investigator: Calero, Karel
Department: Internal Medicine
Sponsor: Veracyte
Opening date: 1/14/2022

Title: Evaluation of the Artificial Intelligence/Machine Learning-Based Diagnostic Software as a Medical Device Using Forced Cough Vocalization Signal Data Signatures in the Diagnosis of COVID-19 Infection: A Prospective, Single Center, Two-Arm Non-Inferiority Trial of AudibleHealth DX Software as a Medical Device (US EUA)
Phase: II
Principal investigator: Kim, Kami
Department: Internal Medicine
Sponsor: RAIsonance
Opening date: 12/16/2021

Title: A Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately Active Ulcerative Colitis
Phase: II
Principal investigator: Seminerio-Diehl, Jennifer
Department: Internal Medicine
Sponsor: Arena
Opening date: 12/13/2021

Title: Evidence for Amyloid Scanning Study, A Study to Improve Precision in Amyloid PET Coverage and Patient Care
Phase: Observational
Principal investigator: Smith, Amanda
Department: Psychiatry
Sponsor: American College of Radiology
Opening date: 12/13/2021

Title: A Long-term Safety Study to Assess the Potential for Chronic Liver Injury in Participants Treated with Epidiolex® Cannabidiol Oral Solution
Phase: IV
Principal investigator: Benbadis, Selim
Department: Neurology
Sponsor: GW Pharmaceuticals
Opening date: 12/10/2021

Title: A Phase 2b/3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Ulcerative Colitis
Phase: IIb/III
Principal investigator: Marcet, Jorge
Department: Surgery
Sponsor: Janssen
Opening date: 12/3/2021

Title: An Open-label Extension Study to Evaluate the Long-term Safety of Inclacumab Administered to Participants with Sickle Cell Disease Who Have Participated in an Inclacumab Clinical Trial
Phase: III
Principal investigator: Rico, Juan
Department: Pediatrics
Sponsor: Global Blood Therapeutics
Opening date: 12/2/2021

Title: An Open-Label, Multicenter Study to Evaluate the Safety and Efficacy of Repeat Intramuscular ABP-450 (prabotulinumtoxinA) Injection for the Treatment of Cervical Dystonia ABP-19002
Phase: II/III
Principal investigator: Hauser, Robert
Department: Neurology
Sponsor: Aeon Biopharma
Opening date: 11/17/2021

Title: Non-Invasive Brainstem Modulation for the Treatment of Non-Motor Symptoms in Parkinson’s Disease: A Randomized Controlled Trial (RCT) and an Open Label Extension (OLE) Study
Phase: N/A
Principal investigator: Hauser, Robert
Department: Neurology
Sponsor: Scion NeuroStim
Opening date: 11/17/2021

Title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Anti-Spike SARS-COV-2 Monoclonal Antibodies as Pre-Exposure Prophylaxis to Prevent COVID-19 in Immunocompromised Participants
Phase: III
Principal investigator: Kim, Kami
Department: Internal Medicine
Sponsor: Regeneron
Opening date: 11/15/2021

Title: A Multicenter, Randomized, Double-Blind, Parallel-Group Study to Assessthe Efficacy and Safety of Oral Etrasimod as Induction and Maintenance Therapy for Moderately to Severely Active Crohn’s Disease
Phase: II/III
Principal investigator: Seminerio-Diehl, Jennifer
Department: Internal Medicine
Sponsor: Arena
Opening date: 11/9/2021

Title: A dose confirmation study of FLT180a (adeno-associated viral vector containing the Padua variant of a codon-optimized human Factor IX gene) in adult subjects with hemophilia B
Phase: I/II
Principal investigator: Visweshwar, Nathan
Department: Internal Medicine
Sponsor: Freeline Therapeutics
Opening date: 11/9/2021

Title: A Phase 3, Multicenter, Randomized, Efficacy Assessor-Blinded Study of Risankizumab Compared to Ustekinumab for the Treatment of Adult Subjects With Moderate to Severe Crohn’s Disease Who Have Failed Anti-TNF therapy
Phase: III
Principal investigator: Seminerio-Diehl, Jennifer
Department: Internal Medicine
Sponsor: Abbvie
Opening date: 11/5/2021

Title: CorEvitas SPHERES (Synergy of Prospective Health & Experimental Research for Emerging Solutions) Registry for Neuromyelitis Optica Spectrum Disorder (NMOSD)
Phase: Observational
Principal investigator: Robertson, Derrick
Department: Neurology
Sponsor: CorEvitas
Opening date: 11/5/2021

Title: A Phase 2, multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy, safety, and tolerability of AVP-786 (deudextromethorphan hydrobromide [d6- DM]/quinidine sulfate [Q]) for the treatment of neurobehavioral disinhibition including aggression, agitation, and irritability in patients with traumatic brain injury (TBI)
Phase: II
Principal investigator: Currier, Glenn
Department: Psychiatry
Sponsor: Avanir Pharmaceuticals
Opening date: 10/29/2021

Title: Long-Term Safety and Efficacy Outcomes Following Previously Administered Short-Term Treatment with SHP607 in Extremely Premature Infants
Phase: IIa
Principal investigator: Ford, Steven
Department: Pediatrics
Sponsor: Takeda
Opening date: 10/22/2021

Title: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Pitolisant on Excessive Daytime Sleepiness and Other Non-Muscular Symptoms in Patients with Myotonic Dystrophy Type 1, Followed by an Open-Label Extension
Phase: II
Principal investigator: Vu, Tuan
Department: Neurology
Sponsor: Harmony Biosciences
Opening date: 10/21/2021

Title: A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate CBP-201 in Adult Patients with Chronic Rhinosinusitis with Nasal Polyps
Phase: II
Principal investigator: Cho, Seong
Department: Internal Medicine
Sponsor: Connect Biopharma
Opening date: 10/20/2021

Title: An Open-Label Study to Evaluate the Long-Term Safety and Efficacy of Lanadelumab for Prevention Against Acute Attacks of Non-histaminergic Angioedema with Normal C1-Inhibitor (C1-INH)
Phase: III
Principal investigator: Ledford, Dennis
Department: Internal Medicine
Sponsor: Takeda
Opening date: 10/18/2021

Title: A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Trial to Evaluate the Efficacy and Safety of Three Dose Levels of KVD824, an Oral Plasma Kallikrein Inhibitor, for Long-Term Prophylactic Treatment of Hereditary Angioedema Type I or II
Phase: II
Principal investigator: Lockey, Richard
Department: Internal Medicine
Sponsor: KalVista
Opening date: 10/18/2021

Title: A Phase 2/3 Randomized, Double-Blind, Double-Dummy, Placebo-Controlled Study to Evaluate the Safety and Efficacy of 2 Regimens of Orally Administered PF-07321332/Ritonavir in Preventing Symtomatic SARS-COV-2 Infection in Adult Household Contacts of Individuals with SARS-COV-2 Infection
Phase: II/III
Principal investigator: Kim, Kami
Department: Internal Medicine
Sponsor: Pfizer
Opening date: 10/18/2021

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Title: A Phase 2, Open-label, Uncontrolled, Single-dose Study to Evaluate the Safety and Tolerability, Pharmacokinetics, and Occurrence of Antidrug Antibody for Nirsevimab in Immunocompromised Children ≤ 24 Months of Age
Phase: II
Principal investigator: Espinosa, Claudia
Department: Pediatrics
Sponsor: MedImmune
Opening date: 10/14/2021

Title: An Interventional Efficacy and Safety, Phase 2/3, Double-Blind, 2-Arm Study to Investigate Orally Administered PF-07321332/Ritonavir Compared With Placebo in Nonhospitalized Symptomatic Adult Participants With COVID-19 Who Are at Low Risk of Progressing to Severe Illness
Phase:  II/III
Principal investigator: Kim, Kami
Department: Internal Medicine
Sponsor: Pfizer
Opening date: 10/14/2021

Title: A Three-Arm, Parallel Group, Randomized, Double-blind, Placebo-controlled Study of the Efficacy, Safety, and Tolerability of AB-2004 in a 13 to 17 year-old Autism Spectrum Disorder Population
Phase: IIb
Principal investigator: Fallon, Daniel
Department: Psychiatry
Sponsor: Axial Therapeutics
Opening date: 10/13/2021

Title: A Phase 2, Prospective, Randomized, Double-Blind, Placebo- Controlled, Single-Dose, Multicenter Study to Evaluate the Efficacy of FX-322 Administered by Intratympanic Injection in Adults with Acquired Sensorineural Hearing Loss
Phase: II
Principal investigator: Sanchez, Victoria
Department: Otolaryngology
Sponsor: Frequency Therapeutics
Opening date: 10/8/2021

Title: A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AL001 in C9orf72-Associated Amyotrophic Lateral Sclerosis
Phase: II
Principal investigator: Vu, Tuan
Department: Neurology
Sponsor: Alector
Opening date: 10/7/2021

Title: An Interventional Efficacy and Safety, Phase 2/3, Double-Blind, 2-Arm Study to Investigate Orally Administered PF-07321332/Ritonavir Compared With Placebo in Nonhospitalized Symptomatic Adult Participants with COVID-19 Who Are at Increased Risk of Progressing to Severe Illness
Phase: II/III
Principal investigator: Kim, Kami
Department: Internal Medicine
Sponsor: Pfizer
Opening date: 10/6/2021

Title: A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Assess the Safety and Efficacy of Inclacumab in Participants With Sickle Cell Disease Experiencing Vasoocclusive Crises
Phase: III
Principal investigator: Rico, Juan
Department: Pediatrics
Sponsor: Global Blood Therapeutics
Opening date: 10/1/2021

Title: A Multiple-Center, Nonrandomized, Open-Label, Adaptive, Single Ascending Dose, Phase I Study to Investigate the Safety, Tolerability, Immunogenicity, Pharmacokinetics, and Pharmacodynamics of RO7121932 Following Intravenous Administration in Patients With Multiple Sclerosis
Phase:  I
Principal investigator: Robertson, Derrick
Department: Neurology
Sponsor: Genentech
Opening date: 9/30/2021

Title: Extracorporeal Photopheresis for the Management of Progressive Bronchiolitis Obliterans Syndrome in Medicare-Eligible Recipients of Lung Allografts (CAG-00324R2)
Phase: Registry
Principal investigator: Patel, Kapil
Department: Internal Medicine
Sponsor: Washington University
Opening date: 9/24/2021

Title: A Phase 1/2a, Controlled, Randomized, Multicenter Study Evaluating the Efficacy, Safety, Tolerability of StrataGraft Skin Tissue Overlay of Meshed Autograft (SOMA) in Treatment of Full-Thickness Thermal Burns
Phase: I/IIa
Principal investigator: Smith, David
Department: Plastic Surgery
Sponsor: Stratatech
Opening date: 9/23/2021

Title: A Follow-up of a Phase 3 Study to Evaluate the Long-term Safety and Efficacy of Darvadstrocel in the Treatment of Complex Perianal Fistula in Subjects With Crohn’s Disease Who Have Participated in ADMIRE II Study
Phase: III
Principal investigator: Sanchez, Jaime
Department: Surgery
Sponsor: Takeda
Opening date: 9/23/2021

Title: ROAR, RiOciguAt UseRs Registry
Phase: IV
Principal investigator: Restrepo-Jaramillo, Ricardo
Department: Internal Medicine
Sponsor: Bayer
Opening date: 9/23/2021

Title: A Phase 2, Randomized, Double-Blind, Multicenter, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Intramuscular ABP-450 (prabotulinumtoxinA) Injection for the Treatment of Cervical Dystonia ABP-19000
Phase: II
Principal investigator: Hauser, Robert
Department: Neurology
Sponsor: Aeon Biopharma
Opening date: 9/23/2021

Title: HEALEY ALS Platform Trial
Phase: II/III
Principal investigator: Vu, Tuan
Department: Neurology
Sponsor: Mass Gen
Opening date: 9/23/2021

Title: A Phase 2, Double-Blind, Randomized, Parallel-Group, Placebo-Controlled, Multi-Center Study to Evaluate the Efficacy, Safety, and Tolerability of Oral Omadacycline in Adult Subjects with Nontuberculous Mycobacterial (NTM) Pulmonary Disease Caused by Mycobacterium abscessus Complex (MABc)
Phase: II
Principal investigator: Sriaroon, Chak
Department: Internal Medicine
Sponsor: Paratek
Opening date: 9/20/2021

Title: A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Rilematovir in Infants and Children (≥28 Days to ≤5 Years of Age) and Subsequently in Neonates
Phase: III
Principal investigator: Espinosa, Claudia
Department: Pediatrics
Sponsor: Janssen
Opening date: 9/17/2021

Title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase 2a Study to Evaluate the Safety, Tolerability, and Early Proof of Concept of TAK-018 for the Prevention of Postoperative Crohn’s Disease Recurrence
Phase: IIa
Principal investigator: Marchioni Beery, Renee
Department: Internal Medicine
Sponsor: Takeda
Opening date: 9/14/2021

Title: A Phase 2A Randomized Double-Blind Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Varoglutamstat (PQ912) in Patients with Early Alzheimer’s Disease with a Stage Gate to Phase 2B (VIVAMIND)
Phase: IIa
Principal investigator: Smith, Amanda
Department: Psychiatry and Behavioral Neurosciences
Sponsor: University of California, San Diego
Opening date: 9/10/2021

Title: A randomized, controlled, multi-center clinical investigation to evaluate and compare the safety and efficacy of using ZOOM reperfusion catheters and stent retrievers in thrombectomy procedures to treat acute ischemic stroke patients
Phase: Device
Principal investigator: Mokin, Maxim
Department: Neurosurgery
Sponsor: Imperative Care, Inc.
Opening date: 9/9/2021

Title: A Phase 1/2, Two-part, Open-label Dose-escalation and Double-blind, Placebo-controlled Dose-expansion Study with an Open-label Extension to Evaluate the Safety and Efficacy of ATA188 in Subjects with Progressive Multiple Sclerosis
Phase: I/II
Principal investigator: Robertson, Derrick
Department: Neurology
Sponsor: Atara Biotherapeutics
Opening date: 9/7/2021

Title: Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Nipocalimab Administered to Adults with Generalized Myasthenia Gravis
Phase: III
Principal investigator: Vu, Tuan
Department: Neurology
Sponsor: Janssen
Opening date: 9/3/2021

Title: A Long-Term, Single-Arm, Open-label, Multicenter Phase 3 Study to Evaluate the Safety and Tolerability of Multiple Subcutaneous Injections of Efgartigimod PH20 SC in Patients With Generalized Myasthenia Gravis
Phase: III
Principal investigator: Vu, Tuan
Department: Neurology
Sponsor: Argenx
Opening date: 8/30/2021

Title: A multicenter, double-blinded and open-label extension study to evaluate the efficacy and safety of ligelizumab as retreatment, self-administered therapy and monotherapy in Chronic Spontaneous Urticaria patients who completed studies CQGE031C2302, CQGE031C2303, CQGE031C2202 or CQGE031C1301
Phase: IIIb
Principal investigator: Ledford, Dennis
Department: Internal Medicine
Sponsor: Novartis
Opening date: 8/24/2021

Title: The IMpact of the Roche Elecsys sFlt-1/PlGF Ratio on Clinical Decision Making in Suspected PreEclampsia (TIME PE)
Phase: Other
Principal investigator: Louis, Judette
Department: Obstetrics and Gynecology
Sponsor: Roche
Opening date: 8/23/2021

Title: A Phase 1/2a Randomized, Double-Blind, Two-Part, Dose-Ascending, Multicenter Study of the Safety and Pharmacokinetics of AR-501 (gallium citrate), Administered via Inhalation, in Healthy Adult and P. aeruginosa Infected Cystic Fibrosis Subjects
Phase: I/IIa
Principal investigator: Floreth, Timothy
Department: Internal Medicine
Sponsor: Aridis Pharmaceuticals
Opening date: 8/13/2021

Title: A Phase 2/3, Two-Part, Open-Label, Dose-Escalation, Age De-escalation and Randomized, Observer-Blind, Placebo-Controlled Expansion Study to Evaluate the Safety, Tolerability, Reactogenicity, and Effectiveness of mRNA-1273 SARS-CoV-2 Vaccine in Healthy Children 6 Months to Less Than 12 Years of Age
Phase: II/III
Principal investigator: Rodriguez, Carina
Department: Pediatrics
Sponsor: Moderna
Opening date: 8/9/2021

Title: Open-Label Exploratory Study of Oral MYK-491 in Stable Ambulatory Patients With Primary Dilated Cardiomyopathy Due to Either MYH7 or TTN Variants
Phase: IIa
Principal investigator: McDonald, Thomas
Department: Cardiology
Sponsor: MyoKardia
Opening date: 8/5/2021

Title: A Phase III, Prospective, Multicenter, Randomized, Controlled Clinical Trial to Demonstrate the Effectiveness and Safety of Liposomal Cyclosporine A (L-CsA) Inhalation Solution Delivered via the PARI Investigational eFlow® Device plus Standard of Care versus Standard of Care Alone in the Treatment of Bronchiolitis Obliterans Syndrome in Patients Post-Double Lung Transplantation
Phase: III
Principal investigator: Patel, Kapil
Department: Internal Medicine
Sponsor: Zambon S.p.A.
Opening date: 8/4/2021

Title: A Phase III, Prospective, Multicenter, Randomized, Controlled Clinical Trial to Demonstrate the Effectiveness and Safety of Liposomal Cyclosporine A (L-CsA) Inhalation Solution Delivered via the PARI Investigational eFlow® Device plus Standard of Care versus Standard of Care Alone in the Treatment of Bronchiolitis Obliterans Syndrome in Patients Post-Single Lung Transplantation
Phase: III
Principal investigator: Patel, Kapil
Department: Internal Medicine
Sponsor: Zambon S.p.A.
Opening date: 8/4/2021

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Title: Long-Chain Fatty Acid Oxidation Disorders In-Clinic Disease Monitoring Program (LC-FAOD DMP)
Phase: IV
Principal investigator: Sanchez-Valle, Amarilis
Department: Pediatrics
Sponsor: Ultragenyx
Opening date: 8/3/2021

Title: A 40-Week, Open-label Extension Study of Trofinetide for the Treatment of Girls and Women with Rett Syndrome
Phase: III
Principal investigator: Ranells, Judith
Department: Pediatrics
Sponsor: Acadia Pharmaceuticals
Opening date: 8/3/2021

Title: A Phase IIB, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to to Evaluate the Efficacy and Safety of Intravenous Prasinezumab in Participants With Early Parkinson’s Disease
Phase: IIb
Principal investigator: Hauser, Robert
Department: Neurology
Sponsor: Genentech
Opening date: 8/2/2021

Title: A Phase 3, Open-Label, Multcenter, Extension Study to Evaluate the Long-Term Safety and Efficacy of Pegcetacoplan in Subjects With Geographic Atrophy Secondary to Age-Related Macular Degeneration
Phase: III
Principal investigator: Bhaleeya, Swetangi
Department: Ophthalmology
Sponsor: Apellis
Opening date: 7/27/2021

Title: A Phase3, Randomized, Double-Blind, Placebo-Controlled Study to Compare the Efficacy and Safety of Sotatercept Versus Placebo when Added to Background Pulmonary Arterial Hypertension (PAH) Therapy for Treatment of PAH
Phase: Device
Principal investigator: Restrepo-Jaramillo, Ricardo
Department: Internal Medicine
Sponsor: Acceleron
Opening date: 7/12/2021

Title: A Phase III Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of PRM-151 in Patients With Idiopathic Pulmonary Fibrosis
Phase: III
Principal investigator: Bandyopadhyay, Debabrata
Department: Internal Medicine
Sponsor: Genentech
Opening date: 7/9/2021

Title: A Phase 2, double-blind, randomized, placebo-controlled study assessing efficacy and safety of SAR441344, a CD40L-antagonist monoclonal antibody, in participants with relapsing multiple sclerosis.
Phase: IIPrincipal investigator: Robertson, Derrick
Department: Neurology
Sponsor: Sanofi
Opening date: 7/8/2021

Title:  Study to evaLuate the EfficAcy and Safety of CardiolRx™ in PatieNts with COVID-19 and Cardiovascular DisEase or Risk Factors A double-blind, placebo-controlled trial (LANCER)
Phase:  II/III
Principal investigator: Oliveira, Guilherme
Department: Internal Medicine
Sponsor: Cardiol Therapeutics
Opening date: 7/8/2021

Title: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Staccato® Granisetron (AZ-010) For the Acute Treatment of Moderate to Severe Cyclic Vomiting Syndrome
Phase:  II
Principal investigator: Velanovich, Vic
Department: Surgery
Sponsor: Alexza Pharmaceuticals
Opening date: 7/7/2021

Title:  A Phase 2 Randomized, Double-blind, Placebo-controlled Safety and Efficacy Trial of Deupirfenidone (LYT-100) in Post-acute COVID-19 Respiratory Disease
Phase:  II
Principal investigator: Oxner, Asa
Department: Internal Medicine
Sponsor: PureTech
Opening date: 7/7/2021

Title:  A Phase 1/2, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of ADP101 for Oral Immunotherapy in Food-Allergic Children and Adults (The Harmony Study)
Phase:  I/II
Principal investigator: Casale, Thomas
Department: Internal Medicine
Sponsor: Alladapt Immunotherapeutics, Inc.
Opening date: 7/2/2021

Title: The NICU Antibiotics and Outcomes Trial (NANO)
Phase: IV
Principal investigator: Randis, Tara
Department: Pediatrics
Sponsor: University of Pittsburg
Opening date: 7/1/2021

Title: A Randomized, Double-Blind, Placebo-Controlled, Two-Part Study in Parkinson’s Disease Patients With Dyskinesia to Assess the Efficacy and Safety/Tolerability of Fixed Dose Combinations of JM-010 and its Individual Components
Phase: II
Principal investigator: Hauser, Robert
Department: Neurology
Sponsor: Bukwang Pharmaceuiticals
Opening date: 6/30/2021

Title: Observational study of innate and adaptive immune cells from blood of highly allergic donors
Phase: Observational
Principal investigator: Casale, Thomas
Department: Internal Medicine
Sponsor: IgGEnix
Opening date: 6/29/2021

Title: A Phase 3, Randomized, Open-Label, Parallel-Group Study to Compare the Pharmacodynamics, Pharmacokinetics, Efficacy, Safety, Tolerability, and Immunogenicity of Multiple Subcutaneous Injections of Efgartigimod PH20 SC With Multiple Intravenous Infusions Phase:  III
Principal investigator: Vu, Tuan
Department: Neurology
Sponsor: Argenx
Opening date: 6/29/2021

Title: Post-Approval Study of the TREO Abdominal Stent- Graft System (P190015) in Patients with Infrarenal Abdominal Aortic and Aorto-iliac Aneurysms
Phase:  N/A
Principal investigator: Shames, Murray
Department: Surgery
Sponsor: Bolton Medical
Opening date: 6/29/2021

Title:  A Phase 1/2 Open-Label, Randomized, Concurrently Controlled, Dose-Escalation Study to Evaluate the Safety and Efficacy of HMI-102 in Adult PKU Subjects with PAH Deficiency
Phase:  I/II
Principal investigator: Sanchez-Valle, Amarilis
Department: Pediatrics
Sponsor: Homology
Opening date: 6/25/2021

Title: The EMPOWER Study: Endometriosis diagnosis using MicroRNA: PrOspective study in Women to allow Early disease Recognition
Phase:  N/A
Principal investigator: Mikhail, Emad
Department: Obstetrics and Gynecology
Sponsor: Dot Laboratories
Opening date: 6/25/2021

Title:  An Extended Access Program to Assess Long-Term Safety of Bardoxolone Methyl in Patients With Chronic Kidney Disease (EAGLE)
Phase:  IIIa
Principal investigator: Doumit, Elias
Department: Internal Medicine
Sponsor: Reata Pharmaceuticals
Opening date: 6/25/2021

Title:  A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study of Orelabrutinib in Patients with Relapsing-Remitting Multiple Sclerosis to Evaluate Efficacy, Safety, Tolerability, Pharmacokinetics, and Biological Activity
Phase:  II
Principal investigator: Moreo, Natalie
Department: Neurology
Sponsor: InnoCare
Opening date: 6/23/2021

Title:  A Randomized, Double-Blind, Controlled Study to Assess the Efficacy and Safety of Intravenous Phenobarbital in Neonatal Seizures
Phase:  III
Principal investigator: Flores-Torres, Jaime
Department: Pediatrics
Sponsor: Hikma
Opening date: 6/21/2021

Title:  A Prospective and Retrospective, Multi-Centre, Post-Market, Non-Interventional Study of Terumo Aortic Cardiovascular Patches, and Knitted and Woven Grafts
Phase:  Post-Market
Principal investigator: Shames, Murray
Department: Surgery
Sponsor: Terumo
Opening date: 6/2/2021

Title:  A Randomized, Double-blind, Placebo-Controlled, 2-Period Crossover, Phase 2 Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Oral TAK-071 in Parkinson Disease Patients With Cognitive Impairment and an Elevated Risk of Falls
Phase:  II
Principal investigator: Zesiewicz, Theresa
Department: Neurology
Sponsor: Takeda
Opening date: 6/1/2021

Title:  A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Ralinepag to Evaluate Safety and Effects on Exercise Capacity Assessed by Cardiopulmonary Exercise Testing in Subjects with World Health Organization Group 1 Pulmonary Hypertension Who Recently Initiated Therapy
Phase:  III
Principal investigator: Restrepo-Jaramillo, Ricardo
Department: Internal Medicine
Sponsor: United Therapeutics
Opening date: 5/28/2021

Title:  A Long-Term Study to Assess the Safety and Efficacy of Lebrikizumab in Patiets With Moderate-to-Severe Atopic Dermatitis
Phase:  III
Principal investigator: Seminario-Vidal, Lucia
Department: Dermatology
Sponsor: Eli Lilly
Opening date: 5/28/2021

Title:  ASSIST™ Registry
Phase:  Registry
Principal investigator: Mokin, Maxim
Department: Neurosurgery
Sponsor: Stryker Neurovascular
Opening date: 5/25/2021

Title:  Efficacy and Safety of M281 in Adults with Warm Autoimmune Hemolytic Anemia: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study
Phase:  II/III
Principal investigator: Walter, Jolan
Department: Pediatrics
Sponsor: Janssen
Opening date: 5/25/2021

Title:  A multicenter, prospective, observational, non-interventional single arm study of the intermediate-term clinical outcomes collected from electronic health records of patients which have previously undergone standard of care implantation of Impella 5.5®
Phase:  Registry
Principal investigator: Katlaps, Gundars
Department: Surgery
Sponsor: ABIOMED
Opening date: 5/19/2021

Title: An Open-Label, Single-Arm, Historically Controlled, Prospective, Multi-Center Phase III Study to Evaluate the Pharmacokinetics and Safety of Immune Globulin Intravenous (Human) GC5107 in Pediatric Subjects with Primary Humoral Immunodeficiency
Phase:  III
Principal investigator: Leiding, Jennifer
Department: Pediatrics
Sponsor: Green Cross
Opening date: 5/18/2021

Title:  A Study to Characterize Rate of Ureagenesis Utilizing Oral [1-13C]Sodium Acetate in the Spectrum of Severity of Patients with Ornithine Transcarbamylase (OTC) Deficiency
Phase:  Observational
Principal investigator: Sanchez-Valle, Amarilis
Department: Pediatrics
Sponsor: Ultragenyx
Opening date: 5/13/2021

* * *

Title:  A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Assess the Efficacy and Safety of JNJ-63733657, an Anti-tau Monoclonal Antibody, in Participants with Early Alzheimer’s Disease
Phase:  II
Principal investigator: Smith, Amanda
Department: Psychiatry
Sponsor: Janssen
Opening date: 5/7/2021 

Title:  A Phase 1b Randomized, Double-blind, Placebo-controlled, Multiple Ascending-dose Study of EQ001 in Subjects with Systemic Lupus Erythematosus with or without Active Proliferative Lupus Nephritis
Phase:  Ib
Principal investigator: Doumit, Elias
Department: Internal Medicine
Sponsor: Equillium, Inc.
Opening date: 5/5/2021 

Title:  A Phase IIIb, Randomized, Multicenter, Active-controlled, Parallelgroup, Non-inferiority, Open-label Study Evaluating the Efficacy, Safety, and Tolerability of Switching to Long-acting Cabotegravir Plus Long-acting Rilpivirine Administered Every Two Months From a Bictegravir/emtricitabine/tenofovir alfenamide Single Tablet Regimen in HIV-1 Infected Adults Who Are Virologically Suppressed
Phase:  IIIb
Principal investigator: Casanas, Beata
Department: Internal Medicine
Sponsor: GlaxoSmithKline
Opening date: 5/4/2021

Title:  Establishing the Safety and Efficacy of Reloxaliase (Oxalate Decarboxylase) in Patients with Enteric Hyperoxaluria: A Phase III Randomized, Double-Blind, Placebo-Controlled Study (URIROX-2)
Phase:  III
Principal investigator: Hernandez, David
Department: Urology
Sponsor: Allena Pharmaceuticals, Inc.
Opening date: 5/4/2021 

Title: Phase 2a Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study of Intravenous ANX005 in Subjects with Amyotrophic Lateral Sclerosis
Phase: IIa
Principal investigator: Vu, Tuan
Department: Neurology
Sponsor: Annexon Biosciences
Opening date: 4/30/2021 

Title: A Phase 3, Multicenter, Randomized, Placebo-controlled, Double-blind Study to Evaluate the Efficacy and Safety of Lanadelumab for Prevention Against Acute Attacks of Non-histaminergic Angioedema with Normal C1-Inhibitor (C1-INH) and Acquired Angioedema (AAE) Due to C1-INH Deficiency
Phase: III
Principal investigator: Ledford, Dennis
Department: Internal Medicine
Sponsor: Dyax
Opening date: 4/27/2021 

Title: Prospective, randomized, double-blind, placebo-controlled, parallel-group trial with an open-label period to investigate the efficacy and safety of NT 201 in the unilateral and bilateral treatment of essential tremor of the upper limb.
Phase:  II
Principal investigator: Zesiewicz, Theresa
Department: Neurology
Sponsor: Merz
Opening date: 4/23/2021 

Title: An Open-Label Study To Evaluate the Pharmacodynamic Effects, Efficacy, Safety, and Tolerability of E2027 in Subjects With Dementia With Lewy Bodies or Parkinson’s Disease Dementia With or Without Amyloid Copathology
Phase: II
Principal investigator: Fils, Jean
Department: Psychiatry
Sponsor: Eisai
Opening date: 4/23/2021

Title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of Pamrevlumab in Subjects with Idiopathic Pulmonary Fibrosis (IPF)
Phase: III
Principal investigator: Bandyopadhyay, Debabrata
Department: Internal Medicine
Sponsor: FibroGen
Opening date: 4/21/2021 

Title: A Randomized, Double-Blind, Placebo-Controlled Dose Escalation and Verification Clinical Study to Assess the Safety and Efficacy of Pulsed, Inhaled Nitric Oxide (iNO) in Subjects at Risk of Pulmonary Hypertension Assocaited with Pulmonary Fibrosis on Long-Term Oxygen Therapy (Part 1 and Part 2)
Phase: IIb/III
Principal investigator: Bandyopadhyay, Debabrata
Department: Internal Medicine
Sponsor: Bellerophon
Opening date: 4/21/2021 

Title: A Double-Blind, Randomized, Parallel-Group Study with Quetiapine Extended Release as Comparator to Evaluate the Efficacy and Safety of Seltorexant 20 mg as Adjunctive Therapy to Antidepressants in Adult and Elderly Patients with Major Depressive Disorder with Insomnia Symptoms Who Have Responded Inadequately to Antidepressant Therapy
Phase: III
Principal investigator: Currier, Glenn
Department: Psychiatry
Sponsor: Janssen
Opening date: 4/20/2021 

Title: A Phase 2 Multicenter, Randomized, Double-Masked, Sham-Controlled Study of the Safety and Efficacy of Intravitreal Injections of NGM621 in Subjects with Geographic Atrophy (GA) secondary to Age-Related Macular Degeneration (AMD)
Phase: II
Principal investigator: Bhaleeya, Swetangi
Department: Ophthalmology
Sponsor: NGM Pharmaceuticals
Opening date: 4/9/2021

Title: A Randomized, Double-Blind, Placebo-Controlled, Study of Oral Trofinetide Versus Placebo in Female Children, Adolescents and Adults with Rett Syndrome
Phase: III
Principal investigator: Ranells, Judith
Department: Pediatrics
Sponsor: Acadia Pharmaceuticals
Opening date: 4/7/2021 

Title: A single-arm, prospective, multi-center, study to explore maintained efficacy with ofatumumab therapy in patients with relapsing multiple sclerosis who discontinue intravenously delivered anti-CD20 monoclonal antibody (aCD20 mAb) therapy (OLIKOS)
Phase: IIIb
Principal investigator: Moreo, Natalie
Department: Neurology
Sponsor: Novartis
Opening date: 4/6/2021

Title: 58 Week Open-Label Trial of Tavapadon in Parkinson’s Disease (Tempo-4 Trial
Phase: III
Principal investigator: Hauser, Robert
Department: Neurology
Sponsor: Cerevel Therapeutics
Opening date: 4/6/2021

Title: A Phase 3, 16-week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Impact of Lebrikizumab on Vaccine Responses in Adult Patients with Moderate-to-Severe Atopic Dermatitis
Phase: III
Principal investigator: Seminario-Vidal, Lucia
Department: Dermatology
Sponsor: Eli Lilly
Opening date: 3/31/2021 

Title: Outcomes of Rare and Sex CHromosome Aneuploidies In Pregnancy Detected via Screening by Cell-free DNA (ORCHIDS)
Phase: N/A
Principal investigator: Obican, Sarah
Department: Obstetrics and Gynecology
Sponsor: Myraid Genetics
Opening date: 3/30/2021

Title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel Arm, Multicenter Study Evaluating the Efficacy and Safety of Pridopidine in Patients with Early Stage of Huntington Disease (PROOF-HD)
Phase:  III
Principal investigator: Aradi, Stephen
Department: Neurology
Sponsor: Prilenia
Opening date: 3/24/2021

Title: A Randomized, Double-Bliind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Dupilumab in Pediatric Patients With Active Eosinophilic Esophagitis
Phase: III
Principal investigator: Sriaroon, Panida
Department: Pediatrics
Sponsor: Regeneron
Opening date: 3/23/2021 

Title: DiVERT Stroke (SeconDary Stroke PreVEntion ThRough Pathway ManagemenT)
Phase:  Retrospective Chart Review
Principal investigator: Rose, David
Department: Neurology
Sponsor: Medtronic
Opening date: 3/23/2021

Title: A Novel Proportional Open Ventilation (POV) Device and Its Efficacy in Managing Acute Respiratory Failure in COVID-19 Patients
Phase: Device 
Principal investigator: Stachura, Zachary
Department: Internal Medicine
Sponsor: Hill-Rom
Opening date: 3/22/2021

Title: A Randomized, Double-Blind, Placebo-Controlled, Phase IIb Study Evaluating the Efficacy of Mesdopetam on Daily ON-Time Without Troublesome Dyskinesia in Patients with Parkinson’s Disease
Phase: IIb
Principal investigator: Hauser, Robert
Department: Neurology
Sponsor: IRLAB
Opening date: 3/19/2021 

Title: A Phase 3, Multi-Center, Double-Blind, Randomized, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Reldesemtiv in Patients with Amyotrophic Lateral Sclerosis (ALS)
Phase: III
Principal investigator: Vu, Tuan
Department: Neurology
Sponsor: Cytokinetics, Inc.
Opening date: 3/19/2021 

Title: A Phase 1B/DA, Multi-Center, Double-Blind, Randomized, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety and Tolerability of AP-PA02 Multi-Phage Therapeutic Candidate for Inhalation in Subjects with Cystic Fibrosis and Chronic Pulmonary Pseudomonas Aeruginosa (PA) Infection
Phase: Ib/IIa
Principal investigator: Floreth, Timothy
Department: Internal Medicine
Sponsor: Armata Pharmaceuticals, Inc.
Opening date: 3/17/2021 

Title: A Phase 3, 12-Month, Open-Label Study of Lasmiditan in Pediatric Patients with Migraine – PIONEER-PEDS2
Phase: III
Principal investigator: Kalidas, Kavita
Department: Neurology
Sponsor: Eli Lilly
Opening date: 3/11/2021 

Title: The Portable Organ Care System (OCS) Heart For Resuscitation, Preservation and Assessment of Hearts from Donors after Circulatory Death Continued Access Protocol (OCS DCD Heart CAP)
Phase: Device
Principal investigator: Lozonschi, Lucian
Department: Surgery
Sponsor: TransMedics
Opening date: 3/11/2021 

Title:  A Randomized, Double-Masked, Active-Controlled Phase 2/3 Study of the Efficacy and Safety of High-Dose Aflibercept in Patients With Diabetic Macular Edema
Phase: II/III
Principal investigator: Bhaleeya, Swetangi
Department: Ophthalmology
Sponsor: Regeneron
Opening date: 3/8/2021 

Title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-and Active-Controlled, Treat-Through Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Moderately to Severely Active Crohn’s Disease
Phase:  III
Principal investigator: Marchioni Beery, Renee
Department: Internal Medicine
Sponsor: Eli Lilly
Opening date: 3/5/2021 

Title: A Double-Blind, Placebo-Controlled, Randomized, 18-Month Phase 2A Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Oral UCB0599 in Study Participants With Early Parkinson’s Disease
Phase: IIa
Principal investigator: Hauser, Robert
Department: Neurology
Sponsor: UCB Biopharma SRL
Opening date: 3/5/2021 

Title: A Prospective, Multi-Center, Single Arm Study to Evaluate the Q Revascularization System for Neurointervention in Acute Ischemic Stroke: The EvaQ Study
Phase: Device
Principal investigator: Mokin, Maxim
Department: Neurosurgery
Sponsor: MIVI Neurosciences
Opening date: 3/3/2021

Title: HEALEY ALS Platform Trial- APPENDIX D FOR PRIDOPIDINE
Phase: II/III
Principal investigator: Vu, Tuan
Department: Neurology
Sponsor: Mass Gen
Opening date: 3/3/2021 

Title:  HEALEY ALS Platform Trial: Regimen-Specific Appendix (RSA) B to Master Protocol Verdiperstat | Home Spirometry and Open-Label Extension (OLE) Period
Phase:  II/III
Principal investigator: Vu, Tuan
Department: Neurology
Sponsor: Mass Gen
Opening date: 3/3/2021 

Title: HEALEY ALS Platform Trial: Regimen-Specific Appendix (RSA) C to Master Protocol CNM-Au8 | Home Spirometry and Open-Label Extension (OLE) Period
Phase: II/III
Principal investigator: Vu, Tuan
Department: Neurology
Sponsor: Mass Gen
Opening date: 3/3/2021 

Title:  HEALEY ALS Platform Trial: Regimen-Specific Appendix (RSA) A to Master Protocol ZILUCOPLAN | Home Spirometry and Open-Label Extension (OLE) Period
Phase: II/III
Principal investigator: Vu, Tuan
Department: Neurology
Sponsor: Mass Gen
Opening date: 3/3/2021

Title: A Phase 1b, Single-blind, Placebo-controlled, Adaptive Design, Outpatient Trial to Assess the Effects of Single Oral Tablet Doses of OPC-214870 on Photic-induced Paroxysmal Electroencephalogram Responses in Subjects Who Have Demonstrated Photoepileptiform Discharges on Electroencephalogram With or Without Seizures
Phase: Ib
Principal investigator: Benbadis, Selim
Department: Neurology
Sponsor: Otsuka
Opening date: 3/2/2021

Title:  A Prospective Study Investigating the Natural History of Adult with Phenylketonuria (PKU) due to Phenylalanine Hydroxylase Deficiency
Phase: N/A
Principal investigator: Sanchez-Valle, Amarilis
Department: Pediatrics
Sponsor: Homology
Opening date: 3/1/2021 

Title: A randomized double-blind placebo-controlled parallel group study assessing the efficacy and safety of dupilumab in patients with Allergic Fungal Rhinosinusitis (AFRS)
Phase: III
Principal investigator: Cho, Seong
Department: Internal Medicine
Sponsor: Sanofi
Opening date: 3/1/2021

* * *

Title: A Randomized, Sham-Controlled, Double-Blind Study of Vagus Nerve Stimulation for Moderate-to-Severe Rheumatoid Arthritis: The RESET-RA Study
Phase: Pivotal
Principal investigator: Bezchilbnyk, Yarima
Department: Neurosurgery
Sponsor: SetPoint Medical, Inc.
Opening date: 2/24/2021

Title:  A multicenter study to assess the safety and effectiveness of the Genio™ dual-sided hypoglossal nerve stimulation system for the treatment of obstructive sleep apnea in adult subjects
Phase: Device
Principal investigator: Padhya, Tapan
Department: Otolaryngology
Sponsor: Nyxoah
Opening date: 2/11/2021 

Title:  An Open-Label Extension Study to Evaluation Rozanolixizumab in Study Participants With Generalized Myasthenia Gravis
Phase:  III
Principal investigator: Vu, Tuan
Department: Neurology
Sponsor: UCB Biopharma SRL
Opening date: 2/10/2021 

Title: A Phase 2a, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ANB019 in the Treatment of Acneiform Rash in Subjects with Cancer Receiving EGFRi or MEKi Therapy
Phase:  IIa
Principal investigator: Seminario-Vidal, Lucia
Department: Dermatology
Sponsor: AnaptysBio
Opening date: 2/8/2021

Title: A Single-Center, Evaluation of Two Adhesive for the PureWick™ Male One-Piece External Catheter in Healthy Volunteers
Phase: Device
Principal investigator: Hernandez, David
Department: Urology
Sponsor: Becton Dickinson
Opening date: 2/8/2021 

Title: A 57-Week, Multicenter, Active-Treatment, Open-Label Extension Trial of CVL-865 as Adjunctive Therapy in Adults With Drug-Resistant Focal Onset Seizures
Phase: II
Principal investigator: Benbadis, Selim
Department: Neurology
Sponsor: Cerevel Therapeutics
Opening date: 2/8/2021 

Title: An Open-Label Extension of Study M15-736 to Evaluate the Safety and Tolerability of 24-Hour Daily Exposure of ABBV-951 in Subjects with Advanced Parkinson’s Disease
Phase: III
Principal investigator: Hauser, Robert
Department: Neurology
Sponsor: Abbvie
Opening date: 2/5/2021 

Title: Efficacy and safety of oral semaglutide versus placebo both in combination with metformin and/or basal insulin in children and adolescents with type 2 diabetes
Phase: IIIb
Principal investigator: Rodriguez, Henry
Department: Diabetes Center
Sponsor: Novo Nordisk
Opening date: 2/4/2021 

Title:  A Phase 2, multicenter, open-label, non-randomized, proof-of-concept study evaluating the efficacy, safety, and tolerability of BIVV020 in adults with chronic inflammatory demyelinating polyneuropathy (CIDP)
Phase:  II
Principal investigator: Vu, Tuan
Department: Neurology
Sponsor: Sanofi
Opening date: 2/4/2021

Title: A Phase 4 Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Apremilast (CC-10004) in Subjects With Early, Oligoarticular Psoriatic Arthritis Despite Initial Stable Treatment With Either
Phase: IV
Principal investigator: Carter, John
Department: Internal Medicine
Sponsor: Amgen
Opening date: 2/2/2021

Title: BD Respiratory Sample Collection for COVID Asymptomatic Pediatric Population
Phase:  N/A
Principal investigator: Oxner, Asa
Department: Internal Medicine
Sponsor: Becton Dickinson
Opening date: 2/1/2021 

Title: A Randomized, Double-Blind, Multicenter, Placebo-Controlled Phase 3 Study With Open-Label Period to Evaluate the Efficacy and Safety of Inebilizumab in Adults With Myasthenia Gravis
Phase: III
Principal investigator: Vu, Tuan
Department: Neurology
Sponsor: VielaBio
Opening date: 1/29/2021

Title: A Phase 1/2 Open-Label, Dose Escalation Study to Determine the Safety and Efficacy of BMN 307, an Adeno-Associated Virus Vector-Mediated Gene Transfer of Human Phenylalanine Hydroxylase in Subjects with Phenylketonuria and Plasma Phe Levels > 600 μmol/L
Phase: I/II
Principal investigator: Sanchez-Valle, Amarilis
Department: Pediatrics
Sponsor: BioMarin
Opening date: 1/21/2021

Title: The Caris Biorepository Research Protocol
Phase: Registry
Principal investigator: Anderson, Matthew
Department: Obstetrics and Gynecology
Sponsor: Caris MPI, Inc.
Opening date: 1/21/2021

Title: Post-Market Clinical Evaluation of the Gentuity High-Frequency Optical Coherence Tomography (HF-OCT) Imaging System and Vis-Rx Micro-Imaging Catheter
Phase: Post-Market
Principal investigator: Matar, Fadi
Department: Internal Medicine
Sponsor: Gentuity
Opening date: 1/14/2021 

Title: A Phase 3, multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy, safety, and tolerability of AVP-786 (deudextromethorphan hydrobromide [d6-DM]/quinidine sulfate [Q]) for the treatment of agitation in patients with dementi
Phase: III
Principal investigator: Fils, Jean
Department: Psychiatry
Sponsor: Avanir Pharmaceuticals
Opening date: 1/14/2021 

Title: Patient Experience Interviews to Inform a Digital Assessment of Huntington’s Disease
Phase: Observational
Principal investigator: Sanchez-Ramos, Juan
Department: Neurology
Sponsor: Evidera
Opening date: 1/13/2021 

Title: Modulation of gut microbiota with NBT-NM108 as an early treatment for suspected or confirmed COVID-19 in patients with prediabetes or type 2 diabetes mellitus (COVGUT20)
Phase:  N/A
Principal investigator: Oxner, Asa
Department: Internal Medicine
Sponsor: Notitia
Opening date: 1/8/2021 

Title: A Phase 1/2, dose-finding, double-blind, placebo-controlled, multi-center study to evaluate the safety, tolerability of intracarotid artery administration of  NCS-01 in patients with acute ischemic stroke
Phase: I/II
Principal investigator: Guerrero, Waldo
Department: Neurosurgery
Sponsor: NC Medical Research Inc.
Opening date: 1/8/2021

Title: A Phase 2 Study to Assess the Virologic Efficacy of REGN10933+REGN10987 Across Different Dose Regiments in Outpatients With SARS-CoV-2 Infection
Phase: II
Principal investigator: Kim, Kami
Department: Internal Medicine
Sponsor: Regeneron
Opening date: 1/8/2021 

Title: Children, Adolescents and Their Providers: the Narcolepsy Assessment Partnership (CATNAPTM)
Phase: Registry
Principal investigator: Nallu, Sagarika
Department: Pediatrics
Sponsor: Pulse Infoframe
Opening date: 1/5/2021 

Title: A Phase IV, Multicenter, Open-label Study to Evaluate the Safety and Pharmacokinetics of BIVIGAM® in Primary Immune Deficiency Disorders in Subjects Aged 2 to 16
Phase: IV
Principal investigator: Leiding, Jennifer
Department: Pediatrics
Sponsor: ADMA Biologics
Opening date: 12/21/2020

Title: A Randomized, Double-blind, Multicenter, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Esketamine Nasal Spray, Administered as Monotherapy, in Adult Participants with Treatment-resistant Depression
Phase: IV
Principal investigator: Currier, Glenn
Department: Psychiatry
Sponsor: Janssen
Opening date: 12/18/2020

Title: The Vivaer® Procedure for Treatment of Nasal Airway Obstruction – A ProspecTive, Multicenter Randomized Controlled TriAl Comparing Vivaer to Sham Control (VATRAC)
Phase: Device
Principal investigator: Tabor, Mark
Department: Otolaryngology
Sponsor: Aerin
Opening date: 12/18/2020

Title: A Randomized, Parallel-Arm, Double-Blind, Placebo-Controlled Study With Open-Label Extension to Assess the Safety and Efficacy of Vatiquinone for the Treatment of Friedreich’s Ataxia
Phase: IIb/III
Principal investigator: Zesiewicz, Theresa
Department: Neurology
Sponsor: PTC Therapeutics
Opening date: 12/15/2020

Title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of LY3451838 in Adults with Treatment-Resistant Migraine
Phase: II
Principal investigator: Kalidas, Kavita
Department: Neurology
Sponsor: Eli Lilly
Opening date: 12/14/2020

Title: TELLOMAK: T-cell Lymphoma anti-KIR3DL2 therapy: An open label, multi-cohort, multi-center phase II study evaluating the efficacy and safety of IPH4102 alone or in combination with chemotherapy in patients with Advanced T-cell lymphoma
Phase: II
Principal investigator: Seminario-Vidal, Lucia
Department: Dermatology
Sponsor: Innate Pharma
Opening date: 12/14/2020 

Title: Open-label Extension of the ARGX-113-1802 Trial to Investigate the Long-term Safety, Tolerability, and Efficacy of Subcutaneously Administered Efgartigimod with rHuPH20 in Patients with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
Phase: II
Principal investigator: Suresh, Niraja
Department: Neurology
Sponsor: Argenx
Opening date: 12/14/2020

* * *

Title: Pediatric Options for Migraine Relief: A Randomized, Double-Blind, Placebo-Controlled Study of Lasmiditan for Acute Treatment of Migraine: PIONEER-PEDS1
Phase:  III
Principal investigator: Kalidas, Kavita
Department: Neurology
Sponsor: Eli Lilly
Opening date: 12/9/2020

Title: Safety and efficacy of CBD (Epidiolex) in Genetic (Idiopathic) Generalized Epilepsy with Typical Absence Seizures
Phase: IV
Principal investigator: Benbadis, Selim
Department: Neurology
Sponsor: GW Pharmaceuticals
Opening date: 12/4/2020

Title: A Phase 3b Study to Evaluate the Safety and Efficacy of Elagolix in Combination with Combined Oral Contraceptives in Premenopausal Women with Documented Endometriosis and Associated Moderate to Severe Pain
Phase: IIIb
Principal investigator: Mikhail, Emad
Department: Obstetrics and Gynecology
Sponsor: Abbvie
Opening date: 12/4/2020

Title: Destination Therapy Post Approval Study (DT PAS) Product Surveillance Registry (PSR) Platform Addendum
Phase:  Registry
Principal investigator: Dunning, John
Department: Surgery
Sponsor: Medtronic
Opening date: 12/4/2020

Title: The RhinAer® Procedure for Treatment of CHronic RhInitis – A Prospective, MulticeNter Randomized ConTrolled TRial Comparing RhinAer to Sham Control  (RHINTRAC)
Phase: Device
Principal investigator: Tabor, Mark
Department: Otolaryngology
Sponsor: Aerin
Opening date: 12/1/2020

Title: Phase 2b/3, Randomized, Double-blind, Placebo-controlled, Parallel Group, Multicenter Study to Evaluate the Safety and Efficacy of Dipraglurant (ADX48621) for the Treatment of Dyskinesia in Patients with Parkinson’s Disease Receiving Levodopa- based Therapy with or without Concomitant Dopaminergic Medications
Phase: IIb/III
Principal investigator: Zesiewicz, Theresa
Department: Neurology
Sponsor: Addex Pharma SA
Opening date: 11/30/2020

Title: A Phase 2a, Randomized, Double-Blind, Placebo-Controlled Study Investigating the Safety of Ritlecitinib (PF-06651600) in Adult Participants With Alopecia Areata
Phase: IIa
Principal investigator: Seminario-Vidal, Lucia
Department: Dermatology
Sponsor: Pfizer
Opening date: 11/30/2020

Title:  A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PEGCETACOPLAN IN SUBJECTS WITH AMYOTROPHIC LATERAL SCLEROSIS (ALS)
Phase: II
Principal investigator: Vu, Tuan
Department: Neurology
Sponsor: Apellis
Opening date: 11/24/2020

Title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 12-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis
Phase: III
Principal investigator: Marchioni Beery, Renee
Department: Internal Medicine
Sponsor: Arena
Opening date: 11/18/2020

Title: A Validation Study to Assess the Validity, Measurement Responsiveness, & Reliability of the Parkinson’s Disease Functional Impacts Digital Instrument (PD-FIDI) in Patients with Parkinson’s Disease (PD) with or without Glucocerebrosidase (GBA) Mutations.
Phase: Device
Principal investigator: Hauser, Robert
Department: Neurology
Sponsor: Sanofi
Opening date: 11/13/2020

Title: Neru AFib Study
Phase: Observational
Principal investigator: Rose, David
Department: Neurology
Sponsor: Mass Gen
Opening date: 11/6/2020

Title: A Randomized, Double-Blind, Placebo-Controlled Study of Galcanezumab in Adolescent Patients 12 to 17 Years of Age with Chronic Migraine – the REBUILD-2 Study
Phase: III
Principal investigator: Kalidas, Kavita
Department: Neurology
Sponsor: Eli Lilly
Opening date: 11/6/2020

Title: A Phase III Multicenter, Randomized, Double-Blind, Double-Dummy, Parallel-Group Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared with Teriflunomide in Adult Patients with Relapsing Multiple Sclerosis
Phase: III
Principal investigator: Robertson, Derrick
Department: Neurology
Sponsor: Genentech
Opening date: 11/3/2020

Title: A PHASE IIIB MULTICENTER, RANDOMIZED, DOUBLE-BLIND, CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY AND PHARMACOKINETICS OF A HIGHER DOSE OF OCRELIZUMAB IN ADULTS WITH PRIMARY PROGRESSIVE MULTIPLE SCLEROSIS
Phase: IIIb
Principal investigator: Robertson, Derrick
Department: Neurology
Sponsor: Genentech
Opening date: 10/30/2020

Title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Crossover Study to Evaluate the Efficacy, Safety, and Tolerability of Oral Ubrogepant in the Acute Treatment of Migraine When Administered During the Prodrome
Phase: III
Principal investigator: Kalidas, Kavita
Department: Neurology
Sponsor: Allergan

Opening date: 10/29/2020
Title:  A Phase 2 Study for the Evaluation of Safety and Efficacy of Humacyte’s Human Acellular Vessel for Vascular Replacement or Reconstruction in Patients with Life or Limb-threatening Vascular Trauma
Phase:  II
Principal investigator: Calero, Aurelia
Department: Surgery
Sponsor: Humacyte, Inc.
Opening date: 10/27/2020 

* * *

Title:  Screening and Lead-in Observational Protocol to Determine Potential Patient Eligibility for Inclusion in AAV Gene Therapy Clinical Trials in Haemophilia B (ECLIPSE)
Phase:  N/A
Principal investigator: Visweshwar, Nathan
Department: Internal Medicine
Sponsor: Freeline Therapeutics
Opening date: 10/15/2020

Title:  A Phase IIIB Multicenter, Randomized, Double-Blind, Controlled Study to Evaluate the
Efficacy, Safety and Pharmacokinetics of a Higher Dose of Ocrelizumab in Adults With Relapsing Multiple Sclerosis
Phase:  IIIb
Principal investigator: Robertson, Derrick
Department: Neurology
Sponsor: Genentech
Opening date: 10/13/2020

Title:  Multicenter, Randomized, Blinded, Placebo-controlled Study to Evaluate the Efficacy of Guselkumab in Subjects with Familial Adenomatous Polyposis
Phase:  Ib
Principal investigator: Marcet, Jorge
Department: Surgery
Sponsor: Janssen
Opening date: 10/9/2020

Title:  A 4-part Phase 1/2 study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of M254 in healthy volunteers and in patients with immune thrombocytopenic purpura
Phase:  I/II
Principal investigator: Walter, Jolan
Department: Pediatrics
Sponsor: Momenta Pharmaceuticals
Opening date: 10/9/2020

Title:  A Phase 4 Multicenter Observational Study to Evaluate the Effectiveness of Patisiran in Patients with Polyneuropathy of Hereditary Transthyretin-Mediated (hATTR) Amyloidosis with a V122I or T60A Mutation
Phase:  IV
Principal investigator: Fernandez, Joel
Department: Internal Medicine
Sponsor: Alnylam Pharmaceuticals
Opening date: 10/9/2020

Title:  A Double-Blind, Placebo-Controlled Study of Cariprazine as an Adjunct to Antidepressants in the Treatment of Patients with Major Depressive Disorder Who Have Had an Inadequate Response to Antidepressants Alone
Phase:  III
Principal investigator: Currier, Glenn
Department: Psychiatry
Sponsor: Abbvie
Opening date: 10/5/2020

Title:  Effisayil™2: Multi-center, randomized, parallel group, double blind, placebo controlled, Phase IIb dose-finding study to evaluate efficacy and safety of BI 655130 (Spesolimab) compared to placebo in preventing generalized pustular psoriasis (GPP)flares in patients with history of GPP
Phase:  IIb
Principal investigator: Seminario-Vidal, Lucia
Department: Dermatology
Sponsor: Boehringer Ingelheim Pharmaceuticals (BIPI)
Opening date: 10/1/2020

Title:  Evaluation of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis in the Treatment of Thoracoabdominal and Pararenal Aortic Aneurysms
Phase:  Device
Principal investigator: Shames, Murray
Department: Surgery
Sponsor: W.L. Gore & Associates, Inc.
Opening date: 9/29/2020

Title:  A Phase III Multicenter, Randomized, Double-Masked, Sham-Controlled Clinical Trial to Assess the Safety and Efficacy of Intravitreal Administration of Zimura™  (Complement C5 Inhibitor) in Patients With Geographic Atrophy Secondary to Dry Age-Related Macular Degeneration
Phase:  III
Principal investigator: Bhaleeya, Swetangi
Department: Ophthalmology
Sponsor: IVERIC Bio
Opening date: 9/29/2020

Title:  A Phase III, Multicenter, Randomized, Parallel Group, Double Blind, Double Dummy, Active Controlled Study of Evobrutinib Compared with Teriflunomide, in Participants with Relapsing Multiple Sclerosis to Evaluate Efficacy and Safety
Phase:  III
Principal investigator: Robertson, Derrick
Department: Neurology
Sponsor: EMD Serono
Opening date: 9/29/2020

Title:  An Open-Label, Randomized, Multicenter Study to Evaluate the Safety Efficacy, Pharmacokinetics and Physician Satisfaction of two different doses of Indigo Carmine Injection 0.8% solution when used as an aid in the determination of ureteral patency.
Phase:  III
Principal investigator: Weigand, Lucas
Department: Urology
Sponsor: Provepharma
Opening date: 9/25/2020

Title:  A single-arm, prospective, multicentre, open-label study to evaluate ofatumumab treatment effectiveness and  patient-reported outcomes in patients with relapsing multiple sclerosis transitioning from dimethyl fumarate or fingolimod therapy
Phase:  IIIb
Principal investigator: Robertson, Derrick
Department: Neurology
Sponsor: Novartis
Opening date: 9/25/2020

Title:  Long-Term, Observational, Registry of Patients With Generalized Myasthenia Gravis Who Have Received Treatment With Complement C5 Inhibition Therapies
Phase:  Observational
Principal investigator: Vu, Tuan
Department: Neurology
Sponsor: Alexion
Opening date: 9/25/2020

Title:  “Embolization of the Middle Meningeal Artery with ONYXTM Liquid Embolic System In the Treatment of Subacute and Chronic Subdural HEmatoma (EMBOLISE)” (“Study”)
Phase:  Device
Principal investigator: Mokin, Maxim
Department: Neurosurgery
Sponsor: Medtronic
Opening date: 9/22/2020

Title:  A Phase 1 Open-Label, Safety, Pharmacokinetic and Preliminary Efficacy Study of STRO-002, an anti-Folate Receptor α (FolRα) Antibody Drug Conjugate (ADC), in Patients with Advanced Epithelial Ovarian Cancer (including Fallopian Tube or Primary Peritoneal Cancers) and Endometrial Cancers
Phase:  I
Principal investigator: Anderson, Matthew
Department: OBGYN
Sponsor: Sutro Biopharma
Opening date: 9/22/2020

Title:  A Phase 3, Single Arm Study of Mirvetuximab Soravtansine in Advanced High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers with High Folate Receptor-Alpha Expression
Phase:  III
Principal investigator: Anderson, Matthew
Department: OBGYN
Sponsor: Immuogen
Opening date: 9/22/2020

Title:  Clinical Evaluation of the Investigational ID NOW™ COVID-19 Assay
Phase:  Device
Principal investigator: Kim, Kami
Department: Internal Medicine
Sponsor: Abbott
Opening date: 9/10/2020

Title:  An Open-Label, Multicenter, Rollover Study to Evaluate the Safety and Tolerability of Long-term Administration of Gantenerumab in Participants with Alzheimer’s Disease
Phase:  III
Principal investigator: Fils, Jean
Department: Psychiatry
Sponsor: Genentech
Opening date: 9/9/2020

Title:  Protocol I5Q-MC-B004: preventive TReatment of mIgraine: oUtcoMes for Patients in real-world Healthcare systems (TRIUMPH)
Phase:  Observational
Principal investigator: Kalidas, Kavita
Department: Neurology
Sponsor: Eli Lilly
Opening date: 8/31/2020

Title:  A Double-blind, Randomized, Placebo-controlled, Parallel-group Trial of the Efficacy and Safety of Nabiximols Oromucosal Spray as Add-on Therapy in Patients with Spasticity Due to Multiple Sclerosis
Phase:  III
Principal investigator: Robertson, Derrick
Department: Neurology
Sponsor: GW Pharmaceuticals
Opening date: 8/28/2020

Title:  A Phase 3 Trial of the Efficacy and Safety of Bardoxolone Methyl in Patients with Autosomal Dominant Polycystic Kidney Disease
Phase:  III
Principal investigator: Doumit, Elias
Department: Internal Medicine
Sponsor: Reata Pharmaceuticals
Opening date: 8/28/2020

Title:  The Parkinson’s Progression Markers Initiative (PPMI) 2.0 Clinical – Establishing a Deeply Phenotyped PD Cohort
Phase:  Observational
Principal investigator: Hauser, Robert
Department: Neurology
Sponsor: MJFF
Opening date: 8/28/2020

Title:  A Phase 2 Trial to Investigate the Efficacy, Safety, and Tolerability of Efgartigimod PH20 SC in Adult Patients with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
Phase:  II
Principal investigator: Suresh, Niraja
Department: Neurology
Sponsor: Argenx
Opening date: 8/27/2020

Title:  HEALEY ALS Platform Trial Platform-Trial for the Treatment of Amyotrophic Lateral Sclerosis (ALS): A perpetual multi-center, multi-regimen clinical trial evaluating the safety and efficacy of investigational products for the treatment of ALS.
Phase:  II/III
Principal investigator: Vu, Tuan
Department: Neurology
Sponsor: Massachusetts General Hospital
Opening date: 8/24/2020

Title:  HEALEY ALS Platform Trial Platform-Trial for the Treatment of Amyotrophic Lateral Sclerosis (ALS): A perpetual multi-center, multi-regimen clinical trial evaluating the safety and efficacy of investigational products for the treatment of ALS. Regimen A Zilucoplan
Phase:  II/III
Principal investigator: Vu, Tuan
Department: Neurology
Sponsor: Massachusetts General Hospital
Opening date: 8/24/2020

Title:  HEALEY ALS Platform Trial Platform-Trial for the Treatment of Amyotrophic Lateral Sclerosis (ALS): A perpetual multi-center, multi-regimen clinical trial evaluating the safety and efficacy of investigational products for the treatment of ALS. Regimen B Verdiperstat
Phase:  II/III
Principal investigator: Vu, Tuan
Department: Neurology
Sponsor: Massachusetts General Hospital
Opening date: 8/24/2020

Title:  HEALEY ALS Platform Trial Platform-Trial for the Treatment of Amyotrophic Lateral Sclerosis (ALS): A perpetual multi-center, multi-regimen clinical trial evaluating the safety and efficacy of investigational products for the treatment of ALS. Regimen C CNM-Au8
Phase:  II/III
Principal investigator: Vu, Tuan
Department: Neurology
Sponsor: Massachusetts General Hospital
Opening date: 8/24/2020

Title:  GALACTIC-1 – A randomized, double-blind, multicentre, parallel, placebo-controlled phase 2b study in subjects with idiopathic pulmonary fibrosis (IPF) investigating the efficacy and safety of TD139, an inhaled galectin-3 inhibitor administered via a dry powder inhaler over 52 weeks
Phase:  IIb
Principal investigator: Bandyopadhyay, Debabrata
Department: Internal Medicine
Sponsor: Galecto
Opening date: 8/22/2020

Title:  A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of Losmapimod in Adult Subjects with COVID-19 (LOSVID STUDY)
Phase:  III
Principal investigator: Calero, Karel
Department: Internal Medicine
Sponsor: Fulcrum
Opening date: 8/21/2020

* * *

Title: A Phase 3, Double-Blind, Randomized, Placebo Controlled, Parallel Group, Flexible Dose, 27 Week Trial to Evaluate the Efficacy, Safety, and Tolerability of Tavapadon as Adjunctive Therapy for Parkinson’s Disease in Levodopa Treated Adults With Motor Fluctuations (TEMPO 3 Trial)
Phase:  III
Principal Investigator: Hauser, Robert
Department: Neurology
Sponsor: Cerevel Therapeutics
Opening date: 8/13/2020 

Title: An Evaluation of Dupilumab in patients with severe eosinophilic chronic sinusitis without nasal polyposis
Phase:  Investigator Initiated
Principal Investigator: Cho, Seong
Department: Internal Medicine
Sponsor: Regeneron
Opening date: 8/12/2020 

Title: Clinical Validation Study of the BHA100 Series BRAUN® CLEAR™ Hearing Aid
Phase:  Device
Principal Investigator: Sanchez, Victoria
Department: Otolaryngology
Sponsor: Helen of Troy
Opening date: 7/27/2020

Title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Assessing the Efficacy and Safety of Anti-Spike SARS-CoV-2 Monoclonal Antibodies in Preventing SARS-Cov-2 Infection in Household Contacts of Individuals Infected with SARS-CoV-2
Phase:  III
Principal Investigator: Kim, Kami
Department: Internal Medicine
Sponsor: Regeneron
Opening date: 7/27/2020

Title: Observational Study in Intermittent Explosive Disorder (IED): Designing an Optimal Measurement Strategy in IED – Validation and Natural History Study
Phase:  II
Principal Investigator: Currier, Glenn
Department: Psychiatry
Sponsor: Endpoint and Outcomes Research
Opening date: 7/24/2020

Title: A Phase III Multicenter, Randomized, Double-Blind, Double-Dummy, Parallel-Group Study to Evaluate the Efficacy and Safety of Fenebrutinib in Adults With Progressive Multiple Sclerosis
Phase:  III
Principal Investigator: Robertson, Derrick
Department: Neurology
Sponsor: Genentech
Opening date: 7/24/2020

Title: Long-Term Tolerability and Safety of Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase (HYQVIA/HyQvia) for the Treatment of Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
Phase:  IIIb
Principal Investigator: Vu, Tuan
Department: Neurology
Sponsor: Baxalta
Opening date: 7/24/2020 

Title: Treatment of Lung Injury from COVID-19 Infection with Intravenous Sodium Nitrite: A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Clinical Study
Phase:  II
Principal Investigator: Calero, Karel
Department: Internal Medicine
Sponsor: Hope Pharmaceuticals
Opening date: 7/22/2020

Title: A Master Protocol Assessing the Safety, Tolerability, and Efficacy of Anti-Spike(s) SARS-COV-2 Monoclonal Antibodies for the Treatment of Ambulatory Patients With COVID-19
Phase:  I/II
Principal Investigator: Kim, Kami
Department: Internal Medicine
Sponsor: Regeneron
Opening date: 7/17/2020

Title: A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of SPR001 (Tildacerfont) in Adult Subjects with Classic Congenital Adrenal Hyperplasia
Phase:  II
Principal Investigator: Candelario, Madeline
Department: Diabetes Center
Sponsor: Spruce Biosciences
Opening date: 7/14/2020

Title: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of SPR001 (Tildacerfont) in Reducing Supraphysiologic Glucocorticoid Use in Adult Subjects with Classic Congenital Adrenal Hyperplasia
Phase:  II
Principal Investigator: Candelario, Madeline
Department: Diabetes Center
Sponsor: Spruce Biosciences
Opening date: 7/14/2020

Title: Evaluation of Updated Continuous Glucose Monitoring (CGM) Form Factor in Adults, Adolescents and Pediatrics
Phase:  Device
Principal Investigator: Shulman, Dorothy
Department: Diabetes Center
Sponsor: Medtronic
Opening date: 7/14/2020

Title: A Phase 2/3 Single-Arm, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of Remdesivir (GS-5734) in Participants from Birth to < 18 Years of Age with COVID-19
Phase:  II/III
Principal Investigator: Rodriguez, Carina
Department: Pediatrics
Sponsor: Gilead
Opening date: 7/14/2020

Title: A RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF NITAZOXANIDE (NTZ) FOR POST-EXPOSURE PROPHYLAXIS OF COVID-19 AND OTHER VIRAL RESPIRATORY ILLNESSES (VRI) IN HEALTHCARE WORKERS
Phase:  III
Principal Investigator: Kim, Kami
Department: Internal Medicine
Sponsor: Romark
Opening date: 7/9/2020

Title: A Master Protocol Assessing the Safety, Tolerability, and Efficacy of Anti-Spike(s) SARS-COV-2 Monoclonal Antibodies for the Treatment of Hospitalized Patients with COVID-19
Phase:  I/II
Principal Investigator: Kim, Kami
Department: Internal Medicine
Sponsor: Regeneron
Opening date: 7/6/2020

Title: AHEAD 3-45 Study: A Placebo-Controlled, Double-Blind, Parallel Treatment Arm, 216 Week Study to Evaluate Efficacy and Safety of Treatment With BAN2401 in Subjects With Preclinical Alzheimer’s Disease and Elevated Amyloid (A45 Trial) and in Subjects With Early Preclinical Alzheimer’s Disease and Intermediate Amyloid (A3 Trial)
Phase:  III
Principal Investigator: Smith, Amanda
Department: Psychiatry
Sponsor: University of Southern California
Opening date: 6/26/2020

Title: A Phase 3, Randomized, Double-Blind, Efficacy and Safety Study Comparing SAR442168 to Placebo in Participants with Primary Progressive Multiple Sclerosis (PERSEUS)
Phase:  III
Principal Investigator: Robertson, Derrick
Department: Neurology
Sponsor: Sanofi
Opening date: 6/26/2020

Title: A Phase 3, Randomized, Double-Blind, Efficacy and Safety Study comparing SAR442168 to Placebo in Participants with Nonrelapsing Secondary Progressive Multiple Sclerosis (HERCULES)
Phase:  III
Principal Investigator: Robertson, Derrick
Department: Neurology
Sponsor: Sanofi
Opening date: 6/26/2020

Title: The CRISIS Study: A randomized open-label study assessing the safety and anti-coronavirus response of combined suppression of host nucleotide synthesis in hospitalized adults with coronavirus-19 (COVID-19)
Phase:  Ia
Principal Investigator: Calero, Karel
Department: Internal Medicine
Sponsor: Clear Creek Bio, Inc.
Opening date: 6/26/2020

Title: A Multicenter, Observational Cohort Study of Women Receiving Standard of Care (SOC) for the Treatment of Pelvic Pain Attributable to Suspected or Confirmed Endometriosis
Phase:  Observational
Principal Investigator: Imudia, Anthony
Department: Obstetrics and Gynecology
Sponsor: Abbvie
Opening date: 6/24/2020

Title: A SINGLE-PERIOD, SINGLE-TREATMENT STUDY OF THE PHARMACOKINETICS AND PHARMCODYNAMICS OF EPINEPHRINE AFTER ADMINISTRATION OF INTRANASAL ARS-1 TO PEDIATRIC SUBJECTS WITH SYSTEMIC ALLERGIES
Phase:  I
Principal Investigator: Lockey, Richard
Department: Internal Medicine
Sponsor: ARS Pharmaceuticals
Opening date: 6/24/2020

Title: Phase 3b open-label, multicenter, safety study of BIIB037 (aducanumab) in subjects with Alzheimer’s disease who had previously participated in the Aducanumab studies 221AD103, 221AD301, 221AD302 and 221AD205
Phase:  IIIb
Principal Investigator: Smith, Amanda
Department: Psychiatry
Sponsor: Biogen
Opening date: 6/22/2020

Title: Randomized, Controlled, Single-blind Study of Probable Benefit of the Neuro-Spinal Scaffold™ for Safety and Neurologic Recovery in Subjects with Complete Thoracic AIS A Spinal Cord Injury as Compared to Standard of Care
Phase:  Pivotal
Principal Investigator: Bezchilbnyk, Yarima
Department: Neurosurgery
Sponsor: InVivo
Opening date: 6/19/2020

Title: SURF: A Prospective, Multicenter Study Assessing the Embolization of Neurovascular lesions using WAVE™ Extra Soft coils, a part of the Penumbra SMART COIL® System
Phase:  Device
Principal Investigator: Ren, Zeguang
Department: Neurosurgery
Sponsor: Penumbra
Opening date: 6/19/2020

Title: A Phase II, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of CVN424 in Parkinson’s Disease Patients with Motor Fluctuations
Phase:  II
Principal Investigator: Hauser, Robert
Department: Neurology
Sponsor: Cerevance
Opening date: 6/19/2020

Title: An Open-Label Extension Study of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis
Phase:  III
Principal Investigator: Marchioni Beery, Renee
Department: Internal Medicine
Sponsor: Arena
Opening date: 6/12/2020

Title: A Prospective, Multi-Center, Randomized, Controlled, Single Blind Clinical Trial Evaluating the Safety and Efficacy of the Cordella™ Pulmonary Artery Sensor System in New York Heart Association (NYHA) Class III Heart Failure Patients (PROACTIVE- HF Trial)
Phase:  Device
Principal Investigator: Fernandez, Joel
Department: Internal Medicine
Sponsor: Endontronix
Opening date: 6/12/2020

Title: Tofacitinib response in UC (TOUR) – a real world prospective multicenter study
Phase:  Registry
Principal Investigator: Seminerio-Diehl, Jennifer
Department: Internal Medicine
Sponsor: University of North Carolina
Opening date: 6/11/2020

Title: A Phase 3, randomized, double-blind efficacy and safety study comparing SAR442168 to teriflunomide (Aubagio®) in participants with relapsing forms of multiple sclerosis (GEMINI 1
Phase:  III
Principal Investigator: Robertson, Derrick
Department: Neurology
Sponsor: Sanofi
Opening date: 6/11/2020

Title: A Multicenter, Double-blind, Placebo-controlled, Randomized Withdrawal, Parallel Group Study of Patiromer for the Management of Hyperkalemia in Subjects Receiving Renin-Angiotensin-Aldosterone System Inhibitor (RAASi) Medications for the Treatment of Heart Failure (DIAMOND)
Phase:  IIIb
Principal Investigator: Fernandez, Joel
Department: Internal Medicine
Sponsor: Relypsa, Inc.
Opening date: 6/10/2020

Title: A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Antiviral Activity of BLD-2660 in Hospitalized Subjects with Recently Diagnosed COVID-19 Compared to Standard of Care Treatment
Phase:  II
Principal Investigator: Myers, Andrew
Department: Internal Medicine
Sponsor: Blade Therapeutics
Opening date: 6/10/2020

Title: AN OPEN-LABEL EXPLORATORY INVESTIGATION OF COGNITIVE OUTCOMES WITH CANNABIDIOL ORALSOLUTION (EPIDIOLEX®; GWP42003-P)(EPI-COG)
Phase:  IV
Principal Investigator: Nallu, Sagarika
Department: Pediatrics
Sponsor: GW Pharmaceuticals
Opening date: 6/1/2020

Title: ABT-CIP-10300 ADROIT Abbott DBS Registry of Outcomes for Indications over Time
Phase:  Post-Market
Principal Investigator: Bezchilbnyk, Yarima
Department: Neurosurgery
Sponsor: Advanced Neuromodulation
Opening date: 6/1/2020

Title: Becton Dickinson Program for Collection of BioSpecimens
Phase:  N/A
Principal Investigator: Oxner, Asa
Department: Internal Medicine
Sponsor: Becton Dickinson
Opening date: 6/1/2020

Title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Assess the Efficacy and Safety of Ruxolitinib in Participants With COVID-19–Associated ARDS Who Require Mechanical Ventilation (RUXCOVID-DEVENT)
Phase:  III
Principal Investigator: Calero, Karel
Department: Internal Medicine
Sponsor: Incyte
Opening date: 5/26/2020

Title: Phase 1b, Open-label study to Evaluate the PK, Safety and Efficacy of B/F/TAF in HIV-1 infected, Virologically Suppressed, Pregnant Women in their Second and Third Trimesters
Phase:  Ib
Principal Investigator: Rodriguez, Carina
Department: Pediatrics
Sponsor: Gilead
Opening date: 5/20/2020

Title: FLowTriever All-Comer Registry for Patient Safety and Hemodynamics (FLASH)
Phase:  Device
Principal Investigator: Hoots, Glenn
Department: Radiology
Sponsor: Inari Medical
Opening date: 5/20/2020

***

Title:  A Human Clinical Study To Collect Calibration And Performance Data For The RBA-2 Device
Phase:  Device
Principal investigator: Oxner, Asa
Department: Internal Medicine
Sponsor: Kaligia Biosciences
Opening date: 5/14/2020

Title:  Single Arm, Open-Label, Multicenter, Registry Study of Revcovi (elapegademase-lvlr) Treatment in ADA-SCID Patients Requiring Enzyme Replacement Therapy
Phase:  IV
Principal investigator: Walter, Jolan
Department: Pediatrics
Sponsor: Leadiant Biosciences
Opening date: 5/14/2020

Title:  Retrospective Independent Safety Review of Closed Irrisept Study
Phase:  Observational
Principal investigator: Davis, Donald
Department: Surgery
Sponsor: IrriMax Corporation
Opening date: 5/11/2020

Title:  “A phase III, randomized, double blind, parallel group, placebo controlled, international, multicenter study to assess efficacy and safety of Cx601, adult allogeneic expanded adipose-derived stem cells (eASC), for the treatment of complex perianal fistula(s) in patients with Crohn’s disease over a period of 24 weeks and a follow-up period up to 52 weeks. ADMIRE-CD II study”
Phase:  III

Principal investigator: Sanchez, Jaime
Department: Surgery
Sponsor: TiGenix
Opening date: 5/11/2020

Title:  A 52 Week, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Safety and Efficacy of Relamorelin in Patients With Gastroparesis
Phase:  III
Principal investigator: Velanovich, Vic
Department: Surgery
Sponsor: Allergan
Opening date: 5/11/2020

Title:  Healthcare Worker Exposure Response and Outcomes of Hydroxychloroquine Trial (HERO-HCQ Trial)
Phase:  III
Principal investigator: Lakshmi, Seetha
Department: Internal Medicine
Sponsor: Duke
Opening date: 5/8/2020

Title:  A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis
Phase:  IIb/III
Principal investigator: Marcet, Jorge
Department: Surgery
Sponsor: Abbvie
Opening date: 5/8/2020

Title:  A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Ulcerative Colitis
Phase:  III
Principal investigator: Marcet, Jorge
Department: Surgery
Sponsor: Abbvie
Opening date: 5/8/2020 

Title:  A Phase 3 Multicenter, Long-Term Extension Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) in Subjects with Ulcerative Colitis
Phase:  III
Principal investigator: Marcet, Jorge
Department: Surgery
Sponsor: Abbvie
Opening date: 5/8/2020 

Title:  A Phase 3, Randomized, Placebo-controlled, Double-blind, Adaptive Study to Evaluate the Safety and Efficacy of Inhaled Treprostinil in Patients with Pulmonary Hypertension due to Chronic Obstructive Pulmonary Disease (PH-COPD)
Phase:  III
Principal investigator: Restrepo-Jaramillo, Ricardo
Department: Internal Medicine
Sponsor: United Therapeutics
Opening date: 5/8/2020

Title:  Comparison of Aerosol Delivery of Infasurf to Usual Care in Spontaneously Breathing RDS Patients
Phase:  I
Principal investigator: Flores-Torres, Jaime
Department: Pediatrics
Sponsor: ONY, Inc.
Opening date: 4/29/2020

Title:  A phase 1b, randomized, double-blinded, placebo-controlled study of hydroxychloroquine in outpatient adults with COVID-19
Phase:  Ib
Principal investigator: Oxner, Asa
Department: Internal Medicine
Sponsor: Sanofi
Opening date: 4/27/2020

Title:  Traditional versus Early Aggressive Therapy for Multiple Sclerosis (TREAT-MS)
Phase:  N/A
Principal investigator: Robertson, Derrick
Department: Neurology
Sponsor: Johns Hopkins School of Medicine
Opening date: 4/24/2020

Title:  Exploring the safety and tolerability of conversion from oral or injectable disease modifying therapies to dose-titrated Oral Siponimod in patients with advancing forms of relapsing multiple sclerosis: A 6-month open label, multi-center Phase IIIb study (EXCHANGE)
Phase:  IIIb
Principal investigator: Robertson, Derrick
Department: Neurology
Sponsor: Novartis
Opening date: 4/24/2020

Title:  A Randomized, Double-Blind, Double-Dummy, Active-Controlled Study Comparing the Efficacy, Safety and Tolerability of ABBV-951 to Oral Carbidopa/Levodopa in Advanced Parkinson’s Disease Patients
Phase:  III
Principal investigator: Hauser, Robert
Department: Neurology
Sponsor: Abbvie
Opening date: 4/21/2020 

Title:  Utilization of Target Ranges to Treat Patients with Parkinson’s Disease by Objective Measurement Using the Personal KinetiGraph® (PKG®) compared to Standard of Care Assessment (TARGET-PD) – A Randomized Controlled Trial
Phase:  Post-Market
Principal investigator: Hauser, Robert
Department: Neurology
Sponsor: Global Kinetics
Opening date: 4/20/2020 

Title:  A Phase 3, Double-Blind, Randomized, Placebo‑Controlled, Parallel‑Group, 27‑Week Study of the Efficacy, Safety, and Tolerability of Two Fixed Doses of Tavapadon in Early Parkinson’s Disease
Phase:  III
Principal investigator: Hauser, Robert
Department: Neurology
Sponsor: Cerevel Therapeutics
Opening date: 4/20/2020 

Title:  A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of 36 Weeks of Treatment with NLY01 in Early-stage Parkinson’s Disease
Phase:  II
Principal investigator: Hauser, Robert
Department: Neurology
Sponsor: Neuraly
Opening date: 4/14/2020

Title:  A Randomized, Single-Masked, Active-Controlled Phase 2 Study of the Safety, Tolerability, and Efficacy of Repeated Doses of High-Dose Aflibercept in Patients with Neovascular Age-Related Macular Degeneration
Phase:  II
Principal investigator: Pavan, Peter
Department: Ophthalmology
Sponsor: Regeneron
Opening date: 4/13/2020 

Title:  Retrospective Study of Surgical Complications in Patients with Defunctioning Stoma After Low Anterior Resection for Rectal Cancer
Phase:  Pending
Principal investigator: Marcet, Jorge
Department: Surgery
Sponsor: SafeHeal
Opening date: 4/7/2020

Title:  Post Approval Study for Non-Adjunctive Use of Dexcom G5® CGM System for Diabetes Management COntinous Monitoring And Control of Hypoglycemia: The COACH Study
Phase:  Device
Principal investigator: Rodriguez, Henry
Department: Pediatrics
Sponsor: Dexcom
Opening date: 4/3/2020

Title:  AN ADAPTIVE PHASE 2/3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY ASSESSING EFFICACY AND SAFETY OF SARILUMAB FOR HOSPITALIZED PATIENTS WITH COVID-19
Phase:  II/III
Principal investigator: Kim, Kami
Department: Internal Medicine
Sponsor: Regeneron
Opening date: 4/2/2020

Title:  A PHASE 3B OPEN-LABEL EXTENSION OF STUDY B23CS (ARENA 2) EVALUATING THE CONTINUED SAFETY AND EFFICACY OF ADV7103 IN SUBJECTS WITH PRIMARY DISTAL RENAL TUBULAR ACIDOSIS
Phase:  IIIb
Principal investigator: Panzarino, Valerie
Department: Pediatrics
Sponsor: Advicenne
Opening date: 4/1/2020 

Title:  Clostridium histolyticum collagenase injection treatment for urethral disease: a prospective pilot, single-center, open-label study
Phase:  II
Principal investigator: Weigand, Lucas
Department: Urology
Sponsor: Endo Pharmaceuticals
Opening date: 4/1/2020

Title:  A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Multicenter Study with an Open-Label Extension to Evaluate the Efficacy and Safety of Ravulizumab in Patients with Amyotrophic Lateral Sclerosis (ALS)
Phase:  III
Principal investigator: Vu, Tuan
Department: Neurology
Sponsor: Alexion
Opening date: 3/27/2020

Title:  A Phase 3, Multi-center, Open-label, Safety Study of Oral Edaravone Administered over 48 Weeks in Subjects with Amyotrophic Lateral Sclerosis (ALS)
Phase:  III
Principal investigator: Vu, Tuan
Department: Neurology
Sponsor: Mitsubishi
Opening date: 3/24/2020

Title:  Master Protocol of two randomized, double-bind, placebo-controlled, multi-center, parallel-group studies of dupilumab in patients with chronic spontaneous urticarial (CSU) who remain symptomatic despite the use of H1anthistamine treatment of two populations-Study A in patients naïve to omalizumab and Study B in patient who are incomplete responders to omalizumab
Phase:  III
Principal investigator: Casale, Thomas
Department: Internal Medicine
Sponsor: Sanofi
Opening date: 3/23/2020

Title:  An educational intervention to increase pediatric and medicine-pediatrics residents’ knowledge and comfort counseling patients about LARCs, comfort with insertion of the contraceptive implant, and intention to provide on-site contraceptive implant services in routine primary care.
Phase:  Investigator Initiated
Principal investigator: Straub, Diane
Department: Pediatrics
Sponsor: Merck
Opening date: 3/20/2020

Title:  A multicenter, randomized, active-controlled, double-blind, double-dummy, parallel group clinical trial, investigating the efficacy, safety, and tolerability of continuous subcutaneous ND0612 infusion in comparison to oral IR-LD/CD in subjects with Parkinson’s disease experiencing motor fluctuations (BouNDless)
Phase:  III
Principal investigator: Hauser, Robert
Department: Neurology
Sponsor: NeuroDerm Ltd.
Opening date: 3/17/2020

Title:  An Open-Label Extension Study to Investigate the Long-Term Safety, Tolerability, and Efficacy of Rozanolixizumab in Subjects with Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
Phase:  IIa
Principal investigator: Vu, Tuan
Department: Neurology
Sponsor: UCB Biosciences
Opening date: 3/17/2020 

Title:  A Comparison of Bimatoprost SR to Selective Laser Trabeculoplasty in Patients with Open-Angle Glaucoma or Ocular Hypertension
Phase:  III
Principal investigator: Ayyala, Ramesh
Department: Ophthalmology
Sponsor: Allergan
Opening date: 3/16/2020

Title:  A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTICENTER TRIAL OF CVL-865 AS ADJUNCTIVE THERAPY IN ADULTS WITH DRUG-RESISTANT FOCAL ONSET SEIZURES (REALIZE TRIAL)
Phase:  II
Principal investigator: Benbadis, Selim
Department: Neurology
Sponsor: Cerevel Therapeutics
Opening date: 3/12/2020 

Title:  A 52-week, phase 3, multicentre, randomised, double blind, efficacy and safety study comparing GSK3196165 with placebo and with tofacitinib, in combination with methotrexate in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to methotrexate
Phase:  III
Principal investigator: Carter, John
Department: Internal Medicine
Sponsor: GlaxoSmithKline
Opening date: 2/27/2020

Title:  Mobile Assessment of Neurocognitive and Psychological Function: A Case-Controlled, Prospective Observational Non-Inferiority Study in Age-Matched Cohorts of Healthy Adults and Adults with Mild Cognitive Impairment
Phase: Device
Principal investigator: Smith, Amanda
Department: Psychiatry
Sponsor: Miro
Opening date: 2/27/2020

Title:  Evaluation of an Advanced Algorithm with CGM in Adults, Adolescents, and Pediatrics
Phase:  Device
Principal investigator: Shulman, Dorothy
Department: Pediatrics
Sponsor: Medtronic
Opening date: 2/24/2020

Title:  A one-year placebo-controlled phase III trial evaluating the efficacy and safety of the house dust mite (HDM) SLIT-tablet in children (5-11 years of age) with HDM allergic rhinitis/rhinoconjunctivitis with or without asthma
Phase:  III
Principal investigator: Lockey, Richard
Department: Internal Medicine
Sponsor: ALK-Abelló A/S
Opening date: 2/20/2020

Title:  A Placebo-Controlled, Double-Blind, Parallel-Group, 18-Month Study With an Open-Label Extension Phase to Confirm Safety and Efficacy of BAN2401 in Subjects With Early Alzheimer’s Disease
Phase:  II
Principal investigator: Smith, Amanda
Department: Psychiatry
Sponsor: Eisai
Opening date: 2/20/2020 

Title:  A Phase 2a Open-Label Trial of the Effects of Intravenous GC4419 on the Incidence and Severity of Esophagitis in Subjects Receiving Chemoradiotherapy for Lung Cancer
Phase:  IIa
Principal investigator: Berk, Lawrence
Department: Radiology
Sponsor: Galera Therapeutics
Opening date: 2/13/2020

Title:  Evaluation of Preterm Infants Fed post-Discharge Preterm Infant Formula with Added Human Milk Oligosaccharide 2’-Fucosyllactose
Phase:  N/A
Principal investigator: Flores-Torres, Jaime
Department: Pediatrics
Sponsor: Abbott
Opening date: 2/13/2020

Title:  A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis
Phase:  III
Principal investigator: Marchioni Beery, Renee
Department: Internal Medicine
Sponsor: Arena
Opening date: 2/13/2020

Title:  A Randomized, Placebo-controlled Trial to Evaluate the Long-term (ie, Maintenance) Efficacy of Oral Aripiprazole in the Treatment of Pediatric Subjects with Tourette’s Disorder
Phase:  IIIb/IV
Principal investigator: Fallon, Daniel
Department: Psychiatry
Sponsor: Otsuka
Opening date: 2/10/2020 

Title:  A 46 WEEK, DOUBLE-BLIND, PLACEBO-CONTROLLED, PHASE 3 STUDY WITH A 6-WEEK RANDOMIZED-WITHDRAWAL PERIOD TO EVALUATE THE SAFETY AND EFFICACY OF RELAMORELIN IN PATIENTS WITH DIABETIC GASTROPARESIS
Phase:  III
Principal investigator: Velanovich, Vic
Department: Surgery
Sponsor: Allergan
Opening date: 2/10/2020

Title:  A RANDOMIZED, MULTICENTER, DOUBLE-BLIND, PARALLEL, ACTIVE-CONTROL STUDY OF THE EFFECTS OF SPARSENTAN, A DUAL ENDOTHELIN RECEPTOR AND ANGIOTENSIN RECEPTOR BLOCKER, ON RENAL OUTCOMES IN PATIENTS WITH PRIMARY FOCAL SEGMENTAL GLOMERULOSCLEROSIS (FSGS)
Phase:  III
Principal investigator: Doumit, Elias
Department: Internal Medicine
Sponsor: Retrophin, Inc.
Opening date: 2/5/2020

***

Title:  An Open-Label Extension Study of the Safety and Clinical Utility of IPX203 in Parkinson’s Disease Patients with Motor Fluctuations
Phase:  N/A
Principal investigator: Hauser, Robert
Department: Neurology
Sponsor: Impax
Opening date: 1/28/2020

Title:  A Randomized, Double-Blind, Placebo-Controlled, Phase 2A Study to Assess the Efficacy and Safety of REGN3500 Monotherapy and Combination of REGN3500 Plus Dupilumab in Adult Patients With Moderate-to-Severe Atopic Dermatitis
Phase:  IIa
Principal investigator: Pepper, Amber
Department: Internal Medicine
Sponsor: Regeneron
Opening date: 1/28/2020

Title:  A Double-blind, Placebo- and Active-controlled Evaluation of the Safety and Efficacy of Levomilnacipran ER in Pediatric Patients 7-17 Years With Major Depressive Disorder
Phase:  III
Principal investigator: Fallon, Daniel
Department: Psychiatry
Sponsor: Allergan
Opening date: 1/28/2020

Title:  Rostock International Parkinson’s Disease Study – An international, multicentre, epidemiological observational study
Phase:  Observational
Principal investigator: Hauser, Robert
Department: Neurology
Sponsor: Centogene
Opening date: 1/28/2020

Title:  A Phase 3, Multicenter, Open-Label Extension Study of Zilucoplan in Subjects with Generalized Myasthenia Gravis
Phase:  III
Principal investigator: Vu, Tuan
Department: Neurology
Sponsor: Ra Pharma
Opening date: 1/27/2020

Title:  A Multicenter Open-label Extension Study to Evaluate the Long-term Safety of Cenobamate Adjunctive Therapy in Subjects with Primary Generalized Tonic-Clonic Seizures
Phase:  III
Principal investigator: Benbadis, Selim
Department: Neurology
Sponsor: SK Life Sciences
Opening date: 1/24/2020

Title:  A phase 3, Randomized, 3-part Study to Investigate the efficacy and safety of Dupilumab in Adult and Adolescent Patients with Eosinophilic Esophagitis
Phase:  III
Principal investigator: Sriaroon, Panida
Department: Pediatrics
Sponsor: Regeneron
Opening date: 1/23/2020

Title:  A Phase 2 Study of ABBV-3067 Alone and in Combinations with ABBV-2222 in Cystic Fibrosis Subjects Who Are Homozygous for the F508del Mutation
Phase:  II
Principal investigator: Patel, Kapil
Department: Internal Medicine
Sponsor: Abbvie
Opening date: 1/22/2020

Title:  Cross-SealTM IDE Trial: Prospective, Multi-Center, Single Arm Study of the Cross-SealTM Suture-Mediated Vascular Closure Device System
Phase:  Device
Principal investigator: Shames, Murray
Department: Surgery
Sponsor: Terumo

Opening date: 1/21/2020
Title:  Biomarker Study in Patients with Amyotrophic Lateral Sclerosis
Phase:  IV
Principal investigator: Vu, Tuan
Department: Neurology
Sponsor: Mitsubishi
Opening date: 1/21/2020

Title:  Mobile Assessment of Neurocognitive and Psychological Function: A Study of Test/Re-Test Reliability in Cohorts of Young and Older Healthy Volunteers
Phase:  I
Principal investigator: Smith, Amanda
Department: Psychiatry
Sponsor: Miro
Opening date: 1/21/2020

Title:  A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2 Crossover Study to Evaluate the Efficacy and Safety of LY3454738 in Adults with Chronic Spontaneous Urticaria Inadequately Controlled with H1-Antihistamines
Phase:  II
Principal investigator: Casale, Thomas
Department: Internal Medicine
Sponsor: Eli Lilly
Opening date: 1/17/2020

Title:  An Assessment of P-15L Bone Graft in Transforaminal Lumbar Interbody Fusion with Instrumentation
Phase:  Device
Principal investigator: Freeman, Thomas
Department: Neurosurgery
Sponsor: Cerapedics, Inc.
Opening date: 1/7/2020

Title:  An Observational Study of Ocrelizumab Treated Patients With Multiple Sclerosis to Determine the Incidence and Mortality Rates of Breat Caner and All Malignancies (VERISMO Study)
Phase:  Observational
Principal investigator: Maldonado, Janice
Department: Neurology
Sponsor: Genentech
Opening date: 12/19/2019

Title:  A Global, Phase 2, Randomized, Double-Blind, Placebo-Controlled, Response-Adaptive Dose-Ranging Study of BMS-986177, an Oral Factor XIa Inhibitor, for the Prevention of New Ischemic Stroke or New Silent Brain Infarction in Patients Receiving Aspirin and C
Phase:  II
Principal investigator: Burgin, William
Department: Neurology
Sponsor: Bristol-Myers Squibb
Opening date: 12/18/2019

Title:  An Open Label Extension Study of Ublituximab in Subjects with Relapsing Multiple Sclerosis
Phase:  III
Principal investigator: Robertson, Derrick
Department: Neurology
Sponsor: TG Therapeutics
Opening date: 12/18/2019

Title:  A Phase 2 Multi-Center, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Safety of TOL-3021 in Patients with New Onset or Established Type 1 Diabetes Mellitus
Phase:  II
Principal investigator: Rodriguez, Henry
Department: Pediatrics
Sponsor: Tolerion
Opening date: 12/16/2019

Title:  Uptravi® (SelexiPag): tHe usErs dRug rEgistry
Phase:  Observational
Principal investigator: Restrepo-Jaramillo, Ricardo
Department: Internal Medicine
Sponsor: Actelion
Opening date: 12/5/2019

Title:  A Randomized, Double-Blind, Placebo-Controlled Phase 1/2 Study of OTO-413 Given as a Single Intratympanic Injection in Subjects With Speech-in-Noise Hearing Impairment
Phase:  I/ II
Principal investigator: Sanchez, Victoria
Department: Otolaryngology
Sponsor: Otonomy
Opening date: 12/2/2019

***

Title:  A Pivotal, Multicenter, Blinded, Sham Procedure-Controlled Trial of Renal Denervation by the Peregrine System™ Kit, in Subjects with Hypertension
Phase:  III
Principal investigator: Matar, Fadi
Department: Cardiology
Sponsor: Ablative Solutions
Opening date: 11/18/2019

Title:  A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of Zilucoplan in Subjects with Immune-Mediated Necrotizing Myopathy
Phase:  II
Principal investigator: Suresh, Niraja
Department: Neurology
Sponsor: Ra Pharma
Opening date: 11/18/2019

Title:  A Multicenter prospective, sample collection study to determine the microbiome of the gastrointestinal tract in subjects with Parkinson’s Disease
Phase:  Observational
Principal investigator: Hauser, Robert
Department: Neurology
Sponsor: Enterin
Opening date: 11/14/2019

Title:  DBS Retro Study – Deep Brain Stimulation (DBS) Retrospective Outcomes Study
Phase:  Registry
Principal investigator: Zesiewicz, Theresa
Department: Neurology
Sponsor: Boston Scientific
Opening date: 11/13/2019

Title:  An Open-Label Study in Adolescent and Adult Severe (Coagulation Factor Activity <1%) Hemophilia A or B Patients With or Without Inhibitors Comparing Standard Treatment to PF-06741086 Prophylaxis
Phase:  III
Principal investigator: Visweshwar, Nathan
Department: Internal Medicine
Sponsor: Pfizer
Opening date: 11/12/2019 

Title:  Registry of Deep Brain Stimulation with the VERCISE™ System
Phase:  Registry
Principal investigator: Zesiewicz, Theresa
Department: Neurology
Sponsor: Boston Scientific
Opening date: 11/12/2019

Title:  A Multi-center, Prospective, Longitudinal, Digital Assessment Study of Disease Progression in Subjects with Early, Untreated Parkinson Disease (PD)
Phase:  Device
Principal investigator: Burke, Deborah
Department: Neurology
Sponsor: University of Rochester
Opening date: 11/12/2019

Title:  A randomized, double-blind, controlled, phase 2/3 study to assess efficacy, long term safety and tolerability of RT001 in subjects with Friedreich’s Ataxia
Phase:  II/III
Principal investigator: Zesiewicz, Theresa
Department: Neurology
Sponsor: Retrotope, Inc.
Opening date: 11/8/2019

Title:  A Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Biomarker Study of the Effects of Dexpramipexole on Eosinophils in Subjects with Eosinophilic Asthma
Phase:  II
Principal investigator: Casale, Thomas
Department: Internal Medicine
Sponsor: Knopp
Opening date: 11/4/2019

Title:  A Phase 2, Randomized, Double-blind Study to Evaluate the Efficacy and Safety of VX-561 in Subjects Aged 18 Years and Older With Cystic Fibrosis
Phase:  II
Principal investigator: Patel, Kapil
Department: Internal Medicine
Sponsor: Vertex
Opening date: 10/31/2019

Title:  An Open-label, Clinical Study to Evaluate the Safety and Tolerability of Treprostinil Inhalation Powder (TreT) in Subjects with Pulmonary Arterial Hypertension Currently Using Tyvaso
Phase:  IbPrincipal investigator: Restrepo-Jaramillo, Ricardo
Department: Internal Medicine
Sponsor: United Therapeutics
Opening date: 10/30/2019

Title:  The TESLA Trial: Thrombectomy for Emergent Salvage of Large Anterior Circulation Ischemic Stroke
Phase:  III
Principal investigator: Mokin, Maxim
Department: Neurosurgery
Sponsor: Mercy Health-St Vincent Medical Center
Opening date: 10/24/2019

Title:  The Organ Care System (OCS™) Lung Thoracic Organ Perfusion (TOP) Post Approval Study (PAS) Registsry – OCS™ Lung TOP PAS Registry
Phase:  Registry|
Principal investigator: Dunning, John
Department: Surgery
Sponsor: TransMedics
Opening date: 10/24/2019

Title:  A Randomized , Multicenter, Double-Blind, Flexibly-dosed, Efficacy and Safety Study of Escitalopram in the Treatment of Children and Adolescents With Generalized Anxiety Disorder
Phase:  III
Principal investigator: Wojas, Justyna
Department: Pediatrics
Sponsor: Allergan
Opening date: 10/24/2019

Title:  A Phase 2a, Prospective, Randomized, Double-Blind, Placebo-Controlled, Single and Repeat-Dose, Multicenter, Exploratory Efficacy Study of FX-322 Administered by Intratympanic Injection in Adults with Stable Sensorineural Hearing Loss
Phase:  IIa
Principal investigator: Boyev, Kestutis
Department: Otolaryngology
Sponsor: Frequency Therapeutics
Opening date: 10/18/2019

Title:  LOTUS: Global Acute Stroke Study utilizing Penumbra System
Phase:  Device
Principal investigator: Ren, Zeguang
Department: Neurosurgery
Sponsor: Penumbra
Opening date: 10/16/2019

Title:  A randomized, double blind, parallel-group, placebo controlled study to evaluate the efficacy and safety of IBP-9414 in premature infants 500-1500g birth weight in the prevention of necrotizing enterocolitis – The Connection study
Phase:  III
Principal investigator: Flores-Torres, Jaime
Department: Neonatology
Sponsor: Infant Bacterial Therapeutics
Opening date: 10/16/2019

Title:  Identification and Validation of a Cut-off for the Ratio of Soluble Fms-like Tyrosine Kinase-1 to Placental Growth Factor (sFlt-1/PlGF) to Stratify Risk in Pregnant Women with Hypertensive Disorders of Pregnancy – PRAECIS
Phase:  I
Principal investigator: Louis, Judette
Department: OBGYN
Sponsor: Cedars-Sinai
Opening date: 10/16/2019

Title:  An observational, non-interventional, study of patients with Hereditary Angioedema in the United States and Canada (EMPOWER Study)
Phase:  Observational
Principal investigator: Lockey, Richard
Department: Internal Medicine
Sponsor: Takeda
Opening date: 10/15/2019

Title:  A Randomized, Open-Label Extension Study to Investigate the Long-Term Safety, Tolerability and Efficacy of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis
Phase:  III
Principal investigator: Vu, Tuan
Department: Neurology
Sponsor: UCB Biosciences
Opening date: 10/11/2019

Title:  A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Upadacitinib in Subjects with Giant Cell Arteritis
Phase:  III
Principal investigator: Lin, Yih Chang
Department: Internal Medicine
Sponsor: Abbvie
Opening date: 10/8/2019

Title:  A Long-Term, Open-Label Study to Evaluate The Safety, Pharmacodynamics, And Efficacy of Migalastat in Subjects > 12 Years of Age With Fabry Disease And Amenable GLA Variants.”
Phase:  Pending
Principal investigator: Sanchez-Valle, Amarilis
Department: Pediatrics
Sponsor: Amicus
Opening date: 10/8/2019

Title:  A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Confirm the Efficacy, Safety, and Tolerability of Zilucoplan in Subjects with Generalized Myasthenia Gravis
Phase:  III
Principal investigator: Vu, Tuan
Department: Neurology
Sponsor: Ra Pharma
Opening date: 10/4/2019

Title:  A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of IgPro20 (Subcutaneous Immunoglobulin, Hizentra®) in Adults With Dermatomyositis (DM)
Phase:  III
Principal investigator: Vu, Tuan
Department: Neurology
Sponsor: CSL Behring
Opening date: 10/3/2019

Title:  A Phase III Study to Evaluate the Efficacy, Safety, and Tolerability of Immune Globulin Infusion 10% Human) with Recombinant Human Hyaluronidase (HYQVIA/HyQvia) and Immune Globulin Infusion (Human), 10% (GAMMAGARD LIQUID/KIOVIG) for the Treatment of Chron
Phase:  III
Principal investigator: Vu, Tuan
Department: Neurology
Sponsor: Baxalta
Opening date: 10/1/2019

Title:  An open label extension study to assess the long term safety of treatment with BI 655130 administered subcutaneously in adult patients with moderate to severe atopic dermatitis.
Phase:  II
Principal investigator: Bennett, Adam
Department: Dermatology
Sponsor: Boehringer Ingelheim Pharmaceuticals (BIPI)
Opening date: 9/27/2019

Title:  ADvance II: A 12-month Double-blind, Randomized, Controlled Study to Evaluate the Safety and Effectiveness of Deep Brain Stimulation of the Fornix (DBS-f) in Patients With Mild Probable Alzheimer’s Disease
Phase:  Device
Principal investigator: Fils, Jean
Department: Psychiatry
Sponsor: Functional Neuromodulation
Opening date: 9/20/2019

Title:  A phase 3b randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of Erenumab in adults with chronic migraine and medication overuse headache.
Phase:  IIIb
Principal investigator: Kalidas, Kavita
Department: Neurology
Sponsor: Amgen
Opening date: 9/19/2019

Title:  A Randomized, Blinded, Parallel Group, Placebo-Controlled, Multiple Dose, Multicenter Study to Compare the Therapeutic Equivalence of Fluticasone Propionate Pressurized Metered Dose Inhaler, 110 mcg, to Flovent® HFA 110 mcg, in Adult Subjects with Asthma
Phase:  III
Principal investigator: Casale, Thomas
Department: Internal Medicine
Sponsor: Teva
Opening date: 9/19/2019

Title:  A Prospective Observational Study of Phenylketonuria (PKU)
Phase:  Observational
Principal investigator: Sanchez-Valle, Amarilis
Department: Pediatrics
Sponsor: BioMarin
Opening date: 9/18/2019

***

Title: Long-term extension safety and efficacy study of SAR442168 in participants with relapsing multiple sclerosis
Phase:  II
Principal investigator: Robertson, Derrick
Department: Neurology
Sponsor: Sanofi
Opening date: 9/17/2019

Title: A Phase 2, randomized, double-blind placebo-controlled study to test the efficacy and safety of KPL 301 in giant cell arteritis
Phase:  II
Principal investigator: Lin, Yih Chang
Department: Internal Medicine
Sponsor: Kiniksa
Opening date: 9/13/2019

Title:  A Randomized, Placebo-Controlled, Double-blind, Multicenter Study to Assess the Efficacy and Safety of Multiple Doses of BMS-986165 in Subjects With Active Psoriatic Arthritis (PsA)
Phase:  II
Principal investigator: Carter, John
Department: Internal Medicine
Sponsor: Bristol-Myers Squibb
Opening date: 9/10/2019

Title:  Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Efficacy and Safety Study with Inhaled RVT-1601 for the Treatment of Persistent Cough in Patients with Idiopathic Pulmonary Fibrosis (IPF): SCENIC Trial
Phase:  IIb
Principal investigator: Patel, Kapil
Department: Internal Medicine
Sponsor: Respivant
Opening date: 8/29/2019

Title:  A Multicenter, Placebo Controlled, Double-Blind, Randomized, Parallel Group Phase 2b Study to Evaluate the Efficacy and Safety of Ecopipam Tablets in Children and Adolescent Patients with Tourette’s Syndrome
Phase:  IIb
Principal investigator: Wojas, Justyna
Department: Pediatrics
Sponsor: Emalex
Opening date: 8/20/2019

Title:  A Phase Ib, Open-Lable, Multicenter Study to Investigate the Pharmacokenetics, Safety, and Tolerability of Subcutaneous Ocrelizumab Administration in Patients With Multiple Sclerosis (Ocarina I)
Phase:  Ib
Principal investigator: Robertson, Derrick
Department: Neurology
Sponsor: Genentech
Opening date: 8/19/2019

Title:  A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Apremilast (CC-10004) in Pediatric Subjects From 6 Through 17 Years of Age With Moderate to Severe Plaque Psoriasis
Phase:  III
Principal investigator: Seminario-Vidal, Lucia
Department: Dermatology
Sponsor: Celgene
Opening date: 8/19/2019

***
Title:  Natural History of Genetic Modifiers in Spinocerebellar Ataxias
Phase:  N/A
Principal investigator: Zesiewicz, Theresa
Department: Neurology
Sponsor: National Ataxia Foundation
Opening date: 8/7/2019

Title:  Evaluation of the VISITAG SURPOINT™ Module with External Processing Unit (EPU) when used with the THERMOCOOL SMARTTOUCH® SF and the THERMOCOOL SMARTTOUCH® Catheters for Pulmonary Vein Isolation (PVI) (SURPOINT COA)
Phase:  Device
Principal investigator: Herweg, Bengt
Department: Cardiology
Sponsor: Biosense
Opening date: 8/7/2019

Title:  A Phase 3 Multicenter, Randomized, Double-Blinded, Placebo-Controlled Withdrawal Study Evaluating ADV7103 In Pediatric And Adult Subjects With Distal Renal Tubular Acidosis (dRTA)
Phase:  III
Department: Pediatrics
Sponsor: Advicenne
Opening date: 7/30/2019

Title:  CLadribine tablets: Observational evaluation of effectIveness and patient-reported outcomes (PROs) in suboptimally Controlled patients previously taKing injectable disease-modifying drugs (DMDs) for relapsing forms of Multiple Sclerosis (RMS) (CLICK-MS)
Phase:  IV
Principal investigator: Robertson, Derrick
Department: Neurology
Sponsor: EMD Serono
Opening date: 7/30/2019

Title:  A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of BHV-3241 in Subjects with Multiple System Atrophy (MSA)
Phase:  III
Principal investigator: Zesiewicz, Theresa
Department: Neurology
Sponsor: Biohaven
Opening date: 7/30/2019

Title:  Cladribine tablets: Observational evaluation of effectiveness and patient-reported outcomes (PROs) in suboptiMAlly controlled patientS previously Taking oral disEase-modifying dRugs (DMDs) for relapsing forms of Multiple Sclerosis (RMS) (MASTER-2)
Phase:  IV
Principal investigator: Robertson, Derrick
Department: Neurology
Sponsor: EMD Serono
Opening date: 7/29/2019

Title:  FLExAbility Sensor Enabled Substrate Targeted Ablation for the Reduction of VT (LESS-VT) Study
Phase:  Device
Principal investigator: Herweg, Bengt
Department: Cardiology
Sponsor: Abbott
Opening date: 7/26/2019

Title:  An open-label, long term extension study to assess the safety and efficacy of BI 655130 treatment in patients with Generalized Pustular Psoriasis (GPP)
Phase:  III
Principal investigator: Seminario-Vidal, Lucia
Department: Dermatology
Sponsor: Boehringer Ingelheim Pharmaceuticals (BIPI)
Opening date: 7/23/2019

Title:  Feasibility Study on Safety Observations Related to Setting Changes Recommended by Personalized Closed Loop (PCL)
Phase:  Device
Principal investigator: Shulman, Dorothy
Department: Pediatrics
Sponsor: Medtronic
Opening date: 7/23/2019

Title:  A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of K0706 in Subjects With Early Parkinson’s Disease
Phase:  II
Principal investigator: Hauser, Robert
Department: Neurology
Sponsor: Sun Pharma Advanced Research Company
Opening date: 7/22/2019

Title:  Effects of oral levosimendan (ODM-109) on respiratory function in patients with ALS: open label extension for patients completing study 3119002
Phase:  III
Principal investigator: Vu, Tuan
Department: Neurology
Sponsor: Orion Pharma
Opening date: 7/22/2019

Title:  Assessment of the WATCHMAN Device in Patients Unsuitable for Oral Anticoagulation
Phase:  Device
Principal investigator: Herweg, Bengt
Department: Cardiology
Sponsor: Boston Scientific
Opening date: 7/19/2019

Title:  Clinical Sample Protocol for Plasma-based Colorectal Cancer Screening Research & Development.
Phase:  Registry
Principal investigator: Marcet, Jorge
Department: Surgery
Sponsor: Epigenomics
Opening date: 7/19/2019

Title:  A Phase 3, Randomized, Double-Blind, Multinational, Placebo-Controlled Study to Evaluate Efficacy and Safety of Teplizumab (PRV-031), a Humanized, FcR Non-Binding, anti-CD3 Monoclonal Antibody, in Children and Adolescents with Newly Diagnosed Type 1 Diabetes
Phase:  III
Principal investigator: Rodriguez, Henry
Department: Pediatrics
Sponsor: Provention Bio
Opening date: 7/12/2019

Title:  A Registry to Further Develop the Understanding of the Real World use of the Eclipse™ System for Fecal Incontinence in Women
Phase:  Registry
Principal investigator: Wyman, Allison
Department: Obstetrics and Gynecology
Sponsor: Pevalon
Opening date: 7/12/2019

Title:  An open-label study to evaluate the long-term safety of daily oral BCX7353 in subjects with Type I and II Hereditary Angioedema
Phase:  II
Principal investigator: Lockey, Richard
Department: Internal Medicine
Sponsor: Biocryst
Opening date: 7/12/2019

Title:  Mapping and Pacing of the His Bundle for Heart Failure Patients with Left Bundle Branch Block
Phase:  Device
Principal investigator: Herweg, Bengt
Department: Cardiology
Sponsor: Abbott
Opening date: 7/9/2019

Title:  A Prospective, Randomized, Double-Blind Comparison of LY900014 to Humalog with an Open-Label Postprandial LY900014 Treatment Group in Children and Adolescents with Type 1 Diabetes PRONTO-Peds
Phase:  III
Principal investigator: Rodriguez, Henry
Department: Pediatrics
Sponsor: Eli Lilly
Opening date: 7/8/2019

Title:  A Randomized, Placebo-controlled Trial to Evaluate the Long-term (ie, Maintenance) Efficacy of Oral Aripiprazole in the Treatment of Pediatric Subjects with Tourette’s Disorder
Phase:  IIIb/IV
Principal investigator: Wojas, Justyna
Department: Pediatrics
Sponsor: Otsuka
Opening date: 7/8/2019

Title:  Multi-center Randomized Controlled Trial in Adult and Pediatric Patients with Type 1 Diabetes Using Hybrid Closed Loop System at Home
Phase:  Device
Principal investigator: Shulman, Dorothy
Department: Pediatrics
Sponsor: Medtronic
Opening date: 7/2/2019

Title:  A Phase 1, Double-Blind, Placebo-Controlled, Single-Ascending-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BIIB100 Administered Orally to Adult Participants With Amyotrophic Lateral Sclerosis
Phase:  I
Principal investigator: Vu, Tuan
Department: Neurology
Sponsor: Biogen
Opening date: 7/2/2019

***

Title:  Safety and Effectiveness Evaluation of the Advanced Hybrid Closed Loop (AHCL) System in Adult and Adolescent Subjects with Type 1 Diabetes
Phase:  Device
Principal investigator: Shulman, Dorothy
Department: Pediatrics
Sponsor: Medtronic
Opening date: 7/11/2019

Title:  A 14-Week, Double-Blind, Randomized, Three Arm, Parallel Group Study to Assess the Efficacy and Safety of Two Doses of Pridopidine versus Placebo for the Treatment of Levodopa Induced Dyskinesia in Patients with Parkinson’s Disease
Phase:  IIb
Principal investigator: Zesiewicz, Theresa
Department: Neurology
Sponsor: Prilenia
Opening date: 7/11/2019

Title:  A Phase 2, Open-label Study to Evaluate the Efficacy and Safety of KB195 in Subjects with a Urea Cycle Disorder with Inadequate Control on Standard of Care
Phase:  II
Principal investigator: Sanchez-Valle, Amarilis
Department: Pediatrics
Sponsor: Kaleido
Opening date: 6/25/2019

Title:  An Open-label Extension Study to Evaluate the Long Term Safety and Tolerability of Intrathecally Administered (RO7234292 (RG6042) in Patients with Huntington’s Disease.
Phase:  III
Principal investigator: Sanchez-Ramos, Juan
Department: Neurology
Sponsor: Genentech
Opening date: 6/25/2019

Title:  RNS System post-approval study in epilepsy
Phase:  Post-Market
Principal investigator: Maciver, Stephanie
Department: Neurology
Sponsor: NeuroPace
Opening date: 6/24/2019

Title:  A Non-Interventional, Retrospective Study of the Natural History and Routine Clinical Management of Congenital Disorders of Glycosylation (CDG)
Phase:  N/A
Principal investigator: Sanchez-Valle, Amarilis
Department: Pediatrics
Sponsor: Cerecor
Opening date: 6/24/2019

Title:  A Phase 3, Multicenter, Open-Label, 40-Week Extension Study to Evaluate the Long-Term Safety and Tolerability of Oral Atogepant for the Prevention of Migraine in Participants with Episodic Migraine
Phase:  III
Principal investigator: Kalidas, Kavita
Department: Neurology
Sponsor: Allergan
Opening date: 6/12/2019

Title:  A Phase 3, Randomized, Double-Blind Study Comparing Risankizumab to Placebo in Subjects with Active Psoriatic Arthritis Including Those Who Have a History of Inadequate Response or Intolerance to Biologic Therapy(ies)
Phase:  III
Principal investigator: Carter, John
Department: Internal Medicine
Sponsor: Abbvie
Opening date: 6/10/2019

Title:  A Phase II Open-Label Extension Study to Evaluate  the Long-Term Safety and Efficacy of Fenebrutinib in Patients Previously Enrolled in a Fenebrutinib Chronic Spontaneous Urticaria Study
Phase:  II
Principal investigator: Casale, Thomas
Department: Internal Medicine
Sponsor: Genentech
Opening date: 6/7/2019

Title:  A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial     to Evaluate Efficacy and Safety of Lenabasum in Dermatomyositis
Phase:  III
Principal investigator: Carter, John
Department: Internal Medicine
Sponsor: Corbus Pharmaceuticals
Opening date: 6/7/2019

Title:  A Phase 2, Randomized, Placebo-Controlled, Double-Masked Study to Assess Safety and Efficacy of Multiple Doses of IONIS-FB-LRX, an Antisense Inhibitor of Complement Factor B, in Patients with Geographic Atrophy Secondary to Age-Related Macular Degeneration
Phase:  II
Principal investigator: Pavan, Peter
Department: Ophthalmology
Sponsor: Ionis Pharmaceuticals
Opening date: 6/3/2019

Title:  A Phase 3, Randomized, Double-Blind, Placebo Controlled Study Evaluating Efficacy and Safety of Rozanolixizumab in Adult Patients with Generalized Myasthenia Gravis.
Phase:  III
Principal investigator: Vu, Tuan
Department: Neurology
Sponsor: UCB Biosciences
Opening date: 5/24/2019

Title:  A 12-week, Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Safety and Efficacy of Relamorelin in Patients With Diabetic Gastroparesis
Phase:  III
Principal investigator: Velanovich, Vic
Department: Surgery
Sponsor: Allergan
Opening date: 5/22/2019

Title:  Phase 3, Multicenter, Double-Masked, Randomized, Vehicle-Controlled, Parallel-Group Study Evaluating the Safety and Efficacy of AGN-190584 in Participants With Presbyopia
Phase:  III
Principal investigator: Ayyala, Ramesh
Department: Ophthalmology
Sponsor: Allergan
Opening date: 5/22/2019

Title:  Topical Ruxolitinib Evaluation in Atopic Dermatitis Study 1 (TRuE-AD1), A Phase 3, Double-Blind, Randomized, 8-Week, Vehicle-Controlled Efficacy and Safety Study of Ruxolitinib Cream Followed by a Long-Term Safety Extension Period in Adolescents and Adult
Phase:  III
Principal investigator: Casale, Thomas
Department: Internal Medicine
Sponsor: Incyte
Opening date: 5/20/2019

Title:  Examining patterns of use for the NanoKnife® Irreversible Electroporation Device in the real world: the NanoKnife Product Registry
Phase:  Registry
Principal investigator: Velanovich, Vic
Department: Surgery
Sponsor: OM1
Opening date: 5/17/2019

Title:  Evaluation of the Personal KinetiGraph™ (PKG™) to Improve Insight into Parkinson’s Disease Status (APPRISE)
Phase:  Device
Principal investigator: Hauser, Robert
Department: Neurology
Sponsor: Global Kinetics
Opening date: 5/16/2019

***

Title:  A Long-Term, Single-Arm, Open-Label, Multicenter, Phase 3 Follow-on Trial of  ARGX-113-1704 to Evaluate the Safety and Tolerability of ARGX-113 in Patients with Myasthenia Gravis having Generalized Muscle Weakness
Phase:  III
Principal investigator: Vu, Tuan
Department: Neurology
Sponsor: Argenx
Opening date: 5/10/2019

Title:  A Phase 3, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study Of The Efficacy and Safety of Apremilast (CC-10004) In Subjects With Mild To Moderate Plaque Psoriasis
Phase:  III
Principal investigator: Bennett, Adam
Department: Dermatology
Sponsor: Celgene
Opening date: 5/1/2019

Title:  A Study to Evaluate the Efficacy and Safety of Dupilumab Monotherapy in Pediatric Patients with Peanut Allergy
Phase:  II
Principal investigator: Casale, Thomas
Department: Internal Medicine
Sponsor: Regeneron
Opening date: 5/1/2019

Title:  Phase IIa multicentre, randomized, double-blind, placebo controlled, study to evaluate the safety, tolerability and efficacy of treatment with BI 655130 in adult patients with moderate to severe atopic dermatitis
Phase:  IIa
Principal investigator: Bennett, Adam
Department: Dermatology
Sponsor: Boehringer Ingelheim Pharmaceuticals (BIPI)
Opening date: 4/29/2019

Title:  LIBERTY EXTENSION: An International Phase 3 Open-Label, Single-Arm, Long-Term Efficacy and Safety Extension Study to Evaluate Relugolix Co-Administered with Low-Dose Estradiol and Norethindrone Acetate in Women with Heavy Menstrual Bleeding Associated with Uterine Fibroids
Phase:  III
Principal investigator: Imudia, Anthony
Department: Obstetrics
Sponsor: Myovant Sciences
Opening date: 4/23/2019

Title:  A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety, Tolerability and Efficacy of XEN1101 as Adjunctive Therapy in Focal-onset Epilepsy
Phase:  II
Principal investigator: Benbadis, Selim
Department: Neurology
Sponsor: Xenon Pharmaceuticals
Opening date: 4/25/2019

Title:  A Multicenter, Randomized, Subject-Blind, Investigator-Blind, Placebo-Controlled, Parallel-Group Study Evaluating the Efficacy, Safety, and Tolerability of Rozanolixizumab in Subjects With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
Phase:  IIa
Principal investigator: Vu, Tuan
Department: Neurology
Sponsor: UCB Biosciences
Opening date: 4/24/2019

 Title:  A Phase III, Multicenter, Randomized, Double-Masked, Active Comparator-Controlled Study to Evaluate the Efficacy and Safety of Faricimab in Patients With Neovascular Age-Related Macular Degeneration (LUCERNE)
Phase:  III
Principal investigator: Pavan, Peter
Department: Ophthalmology
Sponsor: Genentech
Opening date: 4/23/2019

Title:  A randomized, double-blind, multicenter study assessing short (16 weeks) and long-term efficacy (up to 1 year), safety, and tolerability of 2 subcutaneous secukinumab dose regimens in adult patients with moderate to severe hidradenitis suppurativa (SUNSHINE)
Phase:  III
Principal investigator: Seminario-Vidal, Lucia
Department: Dermatology
Sponsor: Novartis
Opening date: 4/23/2019

Title:  An Open-Label, Multicenter Study To Evaluate The Efficacy, Safety, Pharmacokinetics, And Pharmacodynamics Of Eculizumab In Pediatric Patients With Refractory Generalized Myasthenia Gravis
Phase:  III
Principal investigator: Suresh, Niraja
Department: Neurology
Sponsor: Alexion
Opening date: 4/11/2019 

Title:  A Phase 3 Double-blind Randomized Study to Assess the Efficacy and Safety of Intravenous ATB200 Co-administered With Oral AT2221 in Adult Subjects With Late Onset Pompe Disease Compared With Alglucosidase Alfa/Placebo
Phase:  III
Principal investigator: Sanchez-Valle, Amarilis
Department: Pediatrics
Sponsor: Amicus
Opening date: 4/10/2019

Title:  A Phase 2b dose-finding study for SAR442168, a Bruton’s tyrosine kinase inhibitor, in participants with relapsing multiple sclerosis
Phase:  IIb
Principal investigator: Robertson, Derrick
Department: Neurology
Sponsor: Sanofi-Genzyme
Opening date: 4/5/2019 

Title:  A Phase 2 Randomized Double-Blind Placebo-Controlled Trial to Evaluate the Efficacy and Safety of BHV-4157 in Patients with Mild to Moderate Alzheimer’s Disease
Phase:  II
Principal investigator: Smith, Amanda
Department: Psychiatry
Sponsor: UCSD
Opening date: 4/5/2019 

Title:  A Phase 3 Multi-center, Long-term Extension Study Investigating The Efficacy And Safety Of Pf-04965842, With Or Without Topical Medications, Administered To Subjects Aged 12 Years And Older With Moderate To Severe Atopic Dermatitis
Phase:  III
Principal investigator: Casale, Thomas
Department: Internal Medicine
Sponsor: Pfizer
Opening date: 4/2/2019

Title:  An Open-label, Long term Extended Access Protocol for Rapastinel as Adjunctive or Monotherapy Treatment in Patients with Major Depressive Disorder
Phase:  Pending
Principal investigator: Currier, Glenn
Department: Psychiatry
Sponsor: Allergan
Opening date: 4/2/2019 

Title:  Immune Cell Profiling Protocol for WHIM Syndrome
Phase:  Investigator Initiated
Principal investigator: Walter, Jolan
Department: Pediatrics
Sponsor: X4 Pharmaceuticals
Opening date: 3/28/2019

Title:  A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multi-Center Trial to Evaluate the Efficacy and Safety of a Single Treatment of DaxibotulinumtoxinA for Injection in Adults with Isolated Cervical Dystonia (ASPEN-1)
Phase:  III
Principal investigator: Hauser, Robert
Department: Neurology
Sponsor: Revance Therapeutics
Opening date: 3/27/2019

Title:  Efficacy of Repeat Treatments of DaxibotulinumtoxinA for Injection in Adults with Isolated Cervical Dystonia (ASPEN-OLS)
Phase:  III
Principal investigator: Hauser, Robert
Department: Neurology
Sponsor: Revance Therapeutics
Opening date: 3/27/2019

Title:  Exploring the safety and tolerability of conversion from oral or injectable disease modifying therapies to dose-titrated Oral Siponimod in patients with advancing forms of relapsing multiple sclerosis: A 6-month open label, multi-center Phase IIIb study (EXCHANGE)
Phase:  IIIb
Principal investigator: Robertson, Derrick
Department: Neurology
Sponsor: Novartis
Opening date: 3/25/2019

Title:  An Extension Study of ABBV-8E12 in Early Alzheimer’s Disease
Phase:  II
Principal investigator: Smith, Amanda
Department: Psychiatry
Sponsor: Abbvie
Opening date: 3/19/2019

Title:  A prospective, multi-center, Phase 1b/2a study to assess the safety and tolerability of different doses of AG019 administered alone or in association with teplizumab in subjects with clinical recent-onset Type 1 Diabetes Mellitus (T1D).
Phase:  Ib/IIa
Principal investigator: Rodriguez, Henry
Department: Pediatrics
Sponsor: Intrexon
Opening date: 3/7/2019

Title:  A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Ravulizumab in Complement-Inhibitor-Naïve Adult Patients With Generalized Myasthenia Gravis
Phase:  III
Principal investigator: Vu, Tuan
Department: Neurology
Sponsor: Alexion
Opening date: 3/5/2019

Title:  A Randomized Controlled Study to Compare the Safety and Efficacy of IPX203 with Immediate Release-Carbidopa-Levodopa in Parkinson’s disease Patients with Motor Fluctuations
Phase:  III
Principal investigator: Hauser, Robert
Department: Neurology
Sponsor: Impax
Opening date: 2/28/2019

***

Title:  Evaluation of the Performance and Sensitivity of the Clinical Genomics Colvera Test in Predicting Recurrence of Colorectal Cancer (Paired Analysis of Sensitivity for Colorectal Cancer using COLVERA : PASCAL)
Phase:  Observational
Principal investigator: Williams, James
Department: Surgery
Sponsor: Clinical Genomics
Opening date: 2/21/2019

Title:  A double-blind, randomised, placebo-controlled, parallel group trial to evaluate the efficacy and safety of empagliflozin and linagliptin over 26 weeks, with a double-blind active treatment safety extension period up to 52 weeks, in children and adolescents with type 2 diabetes mellitus
Phase:  III
Principal investigator: Rodriguez, Henry
Department: Diabetes
Sponsor: Boehringer Ingelheim Pharmaceuticals (BIPI)
Opening date: 2/19/2019

Title:  A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Phase III Clinical Study to Evaluate the Efficacy and Safety of Intrathecally Administered RO7234292 (RG6042) in Patients With Manifest Huntington’s Disease
Phase:  III
Principal investigator: Sanchez-Ramos, Juan
Department: Neurology
Sponsor: Genentech
Opening date: 2/19/2019

Title:  MammaPrint, BluePrint, and Full-genome Data Linked with Clinical Data to Evaluate New Gene EXpression Profiles: An Adaptable Registry (FLEX Registry)
Phase:  Registry
Principal investigator: Cox, Charles
Department: Surgery
Sponsor: Agendia
Opening date: 2/13/2019

Title:  A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of GBR830 in Adult Subjects with Moderate to Severe Atopic Dermatitis
Phase:  IIb
Principal investigator: Seminario-Vidal, Lucia
Department: Dermatology
Sponsor: Glenmark Pharmaceuticals
Opening date: 2/7/2019

Title:  A Multicenter, Randomized, Double-Blind, Active (Oseltamivir)-Controlled Study to Assess the Safety, Pharmacokinetics, and Efficacy of Baloxavir Marboxil in Otherwise Healthy Pediatric Patients 1 to <12 Years of Age With Influenza-Like Symptoms
Phase:  III
Principal investigator: Rodriguez, Carina
Department: Pediatrics
Sponsor: Genentech
Opening date: 2/5/2019

Title:  A Multi-Center, Randomized, Double-Blind, Placebo- and Active Comparator-Controlled Phase 3 Study with Randomized Withdrawal and Retreatment to Evaluate the Efficacy and Safety of BMS-986165 in Subjects with Moderate-to-Severe Plaque Psoriasis
Phase:  III
Principal investigator: Seminario-Vidal, Lucia
Department: Dermatology
Sponsor: Bristol-Myers Squibb

Opening date: 2/5/2019
Title:  A Randomized, Controlled, Open-Label, Rater-Blinded, Phase 3b Study of the Efficacy, Safety, and Tolerability of 6-Week Extended Interval Dosing of Natalizumab (BG00002) in Subjects With Relapsing-Remitting Multiple Sclerosis Switching From Treatment With 4-Week Natalizumab Standard Interval Dosing (SID) in Relation to Continued SID Treatment
Phase:  IIIb
Principal investigator: Robertson, Derrick
Department: Neurology
Sponsor: Biogen
Opening date: 1/25/2019

Title:  A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study in Pediatric Subjects With Peanut Allergy to Evaluate the Efficacy and Safety of Dupilumab as Adjunct to AR101-CODIT (Peanut Oral Immunotherapy)
Phase:  II
Principal investigator: Casale, Thomas
Department: Internal Medicine
Sponsor: Regeneron
Opening date: 1/24/2019

Title:  A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Parallel-Group Study to Evaluate the Efficacy, Safety, and Tolerability of Multiple Dosing Regimens of Oral Atogepant for the Prevention of Migraine in Patients With Episodic Migraine
Phase:  III
Principal investigator: Kalidas, Kavita
Department: Neurology
Sponsor: Allergan
Opening date: 1/24/2019

Title:  An International Phase 3 Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study to Evaluate Relugolix Administered with and without Low-Dose Estradiol and Norethindrone Acetate in Women with Endometriosis-Associated Pain
Phase:  Pending
Principal investigator: Mikhail, Emad
Department: OB/GYN
Sponsor: Myovant Sciences
Opening date: 1/22/2019

Title:  An open-label, single arm, multi-center extension study evaluating long-term safety, tolerability and effectiveness of ofatumumab in subjects with relapsing multiple sclerosis
Phase:  IIIb
Principal investigator: Robertson, Derrick
Department: Neurology
Sponsor: Novartis
Opening date: 1/18/2019

Title:  A Phase III, Multicenter, Sham-Controlled, Randomized, Double-Masked Study Assessing the Efficacy and Safety of Intravitreal Injections of 440 μg DE-109 for the Treatment of Active, Non-Infectious Uveitis of the Posterior Segment of the Eye- LUMINA
Phase:  III
Principal investigator: Bhaleeya, Swetangi
Department: Ophthalmology
Sponsor: Santen
Opening date: 1/17/2019

Title:  Corrona Inflammatory Bowel Disease (IBD) Registry Study
Phase:  Registry
Principal investigator: Marchioni Beery, Renee
Department: Internal Medicine
Sponsor: Corrona
Opening date: 1/15/2019

Title:  Interviews of English Speaking Patients Completing a Randomized, Controlled Phase 3 Trial in Endometriosis
Phase:  III
Principal investigator: Mikhail, Emad
Department: OB/GYN
Sponsor: Myovant Sciences
Opening date: 1/15/2019
T

Title:  A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Cenobamate Adjunctive Therapy in Subjects with Primary Generalized Tonic-Clonic Seizures
Phase:  III
Principal investigator: Benbadis, Selim
Department: Neurology
Sponsor: SK Life Sciences
Opening date: 1/7/2019

Title:  Multi-center, double-blind, randomized, placebo-controlled, Phase II study to evaluate efficacy, safety and tolerability of a single intravenous dose of BI 655130 in patients with Generalized Pustular Psoriasis (GPP) presenting with an acute flare of moderate to severe intensity.
Phase:  II
Principal investigator: Seminario-Vidal, Lucia
Department: Dermatology
Sponsor: Boehringer Ingelheim Pharmaceuticals (BIPI)Opening date: 1/2/2019

Title:  A randomized, double-blind, placebo-controlled multicenter dose-ranging study to assess the safety and efficacy of multiple oral ZPL389 doses in patients with moderate to severe atopic dermatitis (ZEST trial)
Phase:  II
Principal investigator: Seminario-Vidal, Lucia
Department: Dermatology
Sponsor: Novartis

Opening date: 12/18/2018
Title:  A Phase III, Multicenter, Randomized, Double-Masked, Active Comparator-Controlled Study to Evaluate the Efficacy and Safety of RO6867461 in Patients With Diabetic Macular Edema (YOSEMITE)
Phase:  III
Principal investigator: Pavan, Peter
Department: Ophthalmology
Sponsor: Genentech
Opening date: 12/18/2018

Title:  Internal Medicine Atrial Fibrillation Screening and Educational Initiative
Phase:  Observational
Principal investigator: Oxner, Asa
Department: Internal Medicine
Sponsor: Heart Rhythm Society
Opening date: 12/17/2018

Title:  Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous or Heterozygous for the F508del Mutation
Phase:  III
Principal investigator: Patel, Kapil
Department: Internal Medicine
Sponsor: Vertex
Opening date: 12/12/2018

Title:  A Post-approval Observational Study to Evaluate the Long-term Effectiveness and Safety of Orkambi in US Patients Who Completed Study VX12-809-105 Part A
Phase:  Registry
Principal investigator: Patel, Kapil
Department: Internal Medicine
Sponsor: Vertex
Opening date: 12/11/2018

Title:  A multi-center, randomized, double-blind, active and placebo-controlled study to investigate the efficacy and safety of ligelizumab (QGE031) in the treatment of Chronic Spontaneous Urticaria (CSU) in adolescents and adults inadequately controlled with H1- antihistamines
Phase:  N/A
Principal investigator: Ledford, Dennis
Department: Internal Medicine
Sponsor: Novartis
Opening date: 12/11/2018

Title:  A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of CX-8998 for Essential Tremor – Open Label Digital Substudy #2
Phase:  II
Principal investigator: Hauser, Robert
Department: Neurlogy
Sponsor: Cavion
Opening date: 12/10/2018

Title:  A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study to Evaluate Safety, Tolerability and Efficacy or Orally Administered ENT-01 for the Treatment of Parkinson’s Disease-Related Constipation (KARMET)
Phase:  IIb
Principal investigator: Hauser, Robert
Department: Neurology
Sponsor: Enterin
Opening date: 12/10/2018

Title:  A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Effects of SOtagLiflozin on Clinical Outcomes in HemOdynamIcally STable Patients with Type 2 Diabetes POST Worsening Heart Failure
Phase:  III
Principal investigator: Fernandez, Joel
Department: Cardiology
Sponsor: Sanofi
Opening date: 12/5/2018

Title:  A Multicenter, single-arm, open-label study to assess the safety, pharmacokinetics, and efficacy of Baloxavir Marboxil in otherwise healthy pediatric patients from Birth to <1 year of age with influenza-like sympotoms
Phase:  III
Principal investigator: Rodriguez, Carina
Department: Pediatrics
Sponsor: Genentech
Opening date: 12/5/2018

Title:  A Phase III, multicenter, randomized, double-blind, placebo-controlled, parallel-group, efficacy, and safety study of Gantenerumab in patients with early Prodromal to Mild Alzheimer’s Disease
Phase:  III
Principal investigator: Smith, Amanda
Department: Byrd Alzheimer’s Insitute
Sponsor: Genentech
Opening date: 12/5/2018

Title:  A multicenter, multinational, randomized, controlled, open label study, performed in children with thermal burns, to evaluate the efficacy and safety of NexoBrid compared to Standard of Care (SOC) treatment – MW2012-01-01”
Phase:  III
Principal investigator: Smith, David
Department: Plastic Surgery
Sponsor: MediWound
Opening date: 11/29/2018

Title:  Tolerability, Pharmacokinetics, and Efficacy of MP-101 in the Treatment of Psychosis in Patients with Alzheimer’s Disease
Phase:  I
Principal investigator: Fils, Jean
Department: Psychiatry
Sponsor: Mediti Pharma
Opening date: 11/27/2018

Title:  A Phase III, Long-Term, Randomized, Double-blind, Placebo-controlled Trial of BHV-4157 in Adult Subjects with Spinocerebellar Ataxia
Phase:  III
Principal investigator: Zesiewicz, Theresa
Department: Neurology
Sponsor: Biohaven
Opening date: 11/21/2018

Title:  TRaditional versus Early Aggressive Therapy for Multiple Sclerosis (TREAT-MS) Trial
Phase:  IV
Principal investigator: Robertson, Derrick
Department: Neurology
Sponsor: Johns Hopkins School of Medicine
Opening date: 11/16/2018

***
Title:  An Open-label Extension Study to Evaluate the Safety and Efficacy of Subcutaneous Injections of Pegvaliase (> 40 mg/day Dose) in Adults with Phenylketonuria
Phase:  III
Principal investigator: Sanchez-Valle, Amarilis
Department: Pediatrics
Sponsor: BioMarin
Opening date: 10/31/2018

Title:  A Phase III, Multi-Center, Randomized, Double-Masked, Sham-Controlled Study to Compare the Efficacy and Safety of Intravitreal APL-2 Therapy with Sham Injections in Patients with Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (AMD)
Phase:  III
Principal investigator: Pavan, Peter
Department: Ophthalmology
Sponsor: Apellis
Opening date: 10/30/2018

Title:  A Randomized, Placebo-Controlled Study of the Efficacy and Safety of Intracerebral Stem Cells (CTX0E03 DP) in subjects with Disability Following an Ischemic Stroke (PISCES III)
Phase:  IIb
Principal investigator: Burgin, William
Department: Neurology
Sponsor: ReNeuron
Opening date: 10/29/2018

Title:  A Phase 3 Randomized Withdrawal, Double-blind, Placebo-controlled, Multi-center Study Investigating The Efficacy And Safety Of Pf-04965842 In Subjects Aged 12 Years And Over, With Moderate To Severe Atopic Dermatitis With The Option Of Rescue Treatment In Flaring Subjects
Phase:  III
Principal investigator: Casale, Thomas
Department: Internal Medicine
Sponsor: Pfizer
Opening date: 10/23/2018

Title:  Benefits of µCor in Ambulatory Decompensated Heart Failure
Phase:  Device
Principal investigator: Fernandez, Joel
Department: Cardiology
Sponsor: ZOLL Services, LLC
Opening date: 10/16/2018

Title:  A Durability Study of the Cala TWO Device to Aid in the Transient Relief of Essential Tremor
Phase:  N/A
Principal investigator: Zesiewicz, Theresa
Department: Neurology
Sponsor: Cala Health, Inc.
Opening date: 10/11/2018

Title:  A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase 3 Trial to Evaluate the Efficacy, Safety and Tolerability of ARGX-113 in Patients with Myasthenia Gravis Having Generalized Muscle Weakness
Phase:  III
Principal investigator: Vu, Tuan
Department: Neurology
Sponsor: Argenx
Opening date: 10/11/2018

 Title:  A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Fixed Dose Combination of Bictegravir/Emtricitabine/Tenofovir Alafenamide versus Dolutegravir + Emtricitabine/Tenofovir Disoproxil Fumarate in Treatment Naïve, HIV-1 and Hepatitis B Co-Infected Adults
Phase:  III
Principal investigator: Morano, Jamie
Department: Internal Medicine
Sponsor: Gilead
Opening date: 10/9/2018

Title:  Case-Control Comparison of Separation of Components Repair with Retrorectus Gentrix™ Surgical Matrix versus Biologic Mesh Underlay and Prosthetic Mesh Overlay “Sandwich” Repair of Open Ventral Hernias
Phase:  N/A
Principal investigator: Velanovich, Vic
Department: Surgery
Sponsor: ACell, Inc.
Opening date: 10/9/2018

Title:  Phase III, open-label, single-dose, multi-center multinational trial investigating an serotype 5 adeno-associated viral vector containing the Padua variant of a codon-optimized human factor IX gene (AAV5-hFIXco-Padua, AMT-061) administered to adult subjects with severe or moderately severe hemophilia B
Phase:  III
Principal investigator: Visweshwar, Nathan
Department: Internal Medicine
Sponsor: uniQure
Opening date: 10/2/2018 

Title:  A 52-Week Open-Label Extension Study of Pimavanserin in Adult and Elderly Subjects With Neurodegenerative Disorders
Phase:  IIIb
Principal investigator: Fils, Jean
Department: Psychiatry
Sponsor: Acadia Pharmaceuticals
Opening date: 9/28/2018 

Title:  A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)
Phase:  III
Principal investigator: Patel, Kapil
Department: Internal Medicine
Sponsor: Vertex
Opening date: 9/25/2018 

Title:  A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous for the F508del Mutation (F/F)
Phase:  III
Principal investigator: Patel, Kapil
Department: Internal Medicine
Sponsor: Vertex
Opening date: 9/25/2018

Title:  A Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of AGB101on Slowing Progression of Mild Cognitive Impairment Due to Alzheimer’s Disease
Phase:  III
Principal investigator: Fils, Jean
Department: Psychiatry
Sponsor: AgeneBio, Inc.
Opening date: 9/18/2018

Title:  A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Molindone Hydrochloride Extended-Release Tablets for the Treatment of Impulsive Aggression in Pediatric Patients with Attention Deficit/Hyperactivity Disorder (ADHD) in Conjunction with Standard ADHD Treatment”
Phase:  III
Principal investigator: Fallon, Daniel
Department: Psychiatry
Sponsor: Supernus Pharmaceuticals
Opening date: 9/17/2018

***

Title:  A Multicenter, Open-Label, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib in Adult Patients with Moderate to Severe Atopic Dermatitis
Phase:  III
Principal investigator: Patel, Nishit
Department: Dermatology
Sponsor: Eli Lilly
Opening date: 9/13/2018

Title:  A 12-week randomized open label parallel group multicenter study to evaluate bioequivalence of 20 mg subcutaneous ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients
Phase:  II
Principal investigator: Robertson, Derrick
Department: Neurology
Sponsor: Novartis
Opening date: 9/7/2018

Title:  Functional Neuroimaging Study to Evaluate the Treatment Effect of SPN-810 (Molindone Hydrochloride Extended-Release Tablets) on Impulsive Aggression (IA) in Patients with Attention- Deficit/Hyperactivity Disorder (ADHD) in Conjunction with Standard ADHD Treatment
Phase:  II
Principal investigator: Fallon, Daniel
Department: Psychiatry
Sponsor: Supernus Pharmaceuticals
Opening date: 8/31/2018

Title:  Safety and efficacy of EvomelaR vs propylene glycol melphalan (pg-mel) in high dose melphalan treated hematopoietic stem cell transplant (HSCT) patients
Phase:  N/A
Principal investigator: Perkins, Janelle
Department: Pharmacy
Sponsor: Spectrum Pharmaceuticals
Opening date: 8/29/2018

Title:  Induction Study #2 – A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn’s Disease
Phase:  III
Principal investigator: Marcet, Jorge
Department: Surgery
Sponsor: Celgene
Opening date: 8/27/2018

Title:  A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Maintence Therapy for Moderately to Severely Active Crohn’s Disease
Phase:  III
Principal investigator: Marcet, Jorge
Department: Surgery
Sponsor: Celgene
Opening date: 8/27/2018

Title:  A Phase 3, Multicenter, Open-Label Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn’s Disease
Phase:  III
Principal investigator: Marcet, Jorge
Department: Surgery
Sponsor: Celgene
Opening date: 8/27/2018

Title:  A Phase 3, Multinational, Randomized, Placebo-controlled Study of ARRY-371797 in Patients with Symptomatic Dilated Cardiomyopathy Due to a Lamin A/C Gene Mutation
Phase:  III
Principal investigator: McDonald, Thomas
Department: Cardiology
Sponsor: Array BioPharma
Opening date: 8/17/20

Title:  A Phase 2, Prospective, Interventional, Open-Label, Multi-Site, Extension Study to Assess the Long-Term Safety and Tolerability of TAK-935 as Adjunctive Therapy in Patients with Rare Epilepsy
Phase:  II
Principal investigator: Benbadis, Selim
Department: Neurology
Sponsor: Ovid Therapeutics
Opening date: 8/16/2018

Title:  A randomized, double-blind, multicenter study assessing short (16 weeks) and long-term efficacy (up to 1 year), safety, and tolerability of sub-cutaneous secukinumab in subjects of body weight 90 kg or higher with moderate to severe chronic plaque-type psoriasis
Phase:  IIIb
Principal investigator: Seminario-Vidal, Lucia
Department: Dermatology
Sponsor: Novartis
Opening date: 8/14/2018

Title:  An Open-Label, Single-Arm 4-Year Study to Evaluate Effectiveness and Safety of Ocrelizumab Treatment in Patients With Progressive Multiple Sclerosis
Phase:  IIb
Principal investigator: Robertson, Derrick
Department: Neurology
Sponsor: Genentech
Opening date: 8/2/2018

Title:  A Phase 3b, Multicenter, Randomized, Double-blind, Placebo-controlled, Safety Study of Pimavanserin Therapy in Adult and Elderly Subjects Experiencing Psychosis Related to Neurodegenerative Disease
Phase:  IIIb
Principal investigator: Fils, Jean
Department: Psychiatry
Sponsor: Acadia Pharmaceuticals
Opening date: 8/1/2018

Title:  A 26-week Randomized, Double-blind, Controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Sotagliflozin compared to Empagliflozin, and Placebo in Patients with Type 2 Diabetes Who Have Inadequate Glycemic Control on Dipeptidyl Peptidase 4 Inhibitor (DPP4(i)) With or Without Metformin
Phase:  Pending
Principal investigator: Jacovino, Crystal
Department: Internal Medicine
Sponsor: Sanofi
Opening date: 7/31/2018

Title:  A randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of CNP520 in participants at risk for the onset of clinical symptoms of Alzheimer’s Disease (AD)
Phase:  II/III
Principal investigator: Smith, Amanda
Department: Psychiatry
Sponsor: Novartis
Opening date: 7/27/2018

Title:  A single-center prospective measurement of upper extremity strength in non-ambulatory multiple sclerosis patients treated with Ocrevus
Phase:  Investigator Initiated
Principal investigator: Maldonado, Janice
Department: Neurology
Sponsor: Genentech
Opening date: 7/26/2018

Title:  A Randomized, Double-Blind, Placebo-Controlled Study of Galcanezumab in Adults with Treatment-Resistant Migraine – the CONQUER Study
Phase:  III
Principal investigator: Kalidas, Kavita
Department: Neurology
Sponsor: Eli Lilly
Opening date: 7/17/2018

***

Title:  A Double-Blind, Placebo-Controlled, Randomized Withdrawal, Multicenter Clinical Trial Evaluating The Efficacy, Safety, And Tolerability Of Cariprazine In A Dose-Reduction Paradigm In The Prevention Of Relapse In Bipolar I Disorder Patients Whose Current Episode Is Manic Or Depressive With Or Without Mixed Features
Phase:  IIIb
Principal investigator: Fils, Jean
Department: Psychiatry
Sponsor: Allergan
Opening date: 6/25/2018

Title:  An Open-Label, Long-Term Safety Study Including a Double-Blind, Placebo-Controlled, Randomized Withdrawal Period of TEV-50717 (deutetrabenazine) for the Treatment of Tourette Syndrome in Children and Adolescents
Phase:  III
Principal investigator: Murphy, Tanya
Department: Pediatrics
Sponsor: Nuvelution
Opening date: 6/4/2018

Title:  A Prospective, Open-Label, Multicenter Study of the Efficacy, Safety, Tolerability, and Pharmacokinetics of Therapure PlasmaCap IG in Adults and Children with Primary Immune Deficiency Diseases
Phase:  III
Principal investigator: Leiding, Jennifer
Department: Pediatrics
Sponsor: Therapure
Opening date: 5/17/2018

Title:  A Randomized, Double-Blind, Placebo-Controlled Study of Galcanezumab in  Patients 6 to 17 Years of Age with Episodic Migraine
Phase:  N/A
Principal investigator: Kalidas, Kavita
Department: Neurology
Sponsor: Eli Lilly
Opening date: 5/17/2018 

 Title:  A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Alogliptin Compared With Placebo in Pediatric Subjects With Type 2 Diabetes Mellitus Phase 3 Alogliptin Pediatric Study
Phase:  III
Principal investigator: Rodriguez, Henry
Department: Diabetes Center
Sponsor: Takeda
Opening date: 5/11/2018

Title:  A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial to Evaluate Efficacy and Safety of Lenabasum in Cystic Fibrosis
Phase:  III
Principal investigator: Patel, Kapil
Department: Internal Medicine
Sponsor: Corbus Pharmaceuticals
Opening date: 5/9/2018 

Title:  Evaluation of Treatment Strategies for Severe CaLcIfic Coronary Arteries: Orbital Atherectomy vs. Conventional Angioplasty Technique Prior to Implantation of Drug-Eluting StEnts (ECLIPSE)
Phase:  Device
Principal investigator: Matar, Fadi
Department: Cardiology
Sponsor: Cardiovascular Systems
Opening date: 4/27/2018

Title:  A Phase III, randomized, multicenter, parallel-group, non-inferiority study evaluating the efficacy, safety, and tolerability of switching to dolutegravir plus lamivudine in HIV-1 infected adults who are virologically suppressed
Phase:  III
Principal investigator: Casanas, Beata
Department: Internal Medicine
Sponsor: GlaxoSmithKline
Opening date: 4/25/2018 

Title:  Development of Population Health Software
Phase:  N/A
Principal investigator: Berlowitz, Michael
Department: Cardiology
Sponsor: Medtronic
Opening date: 4/19/2018

Title:  Evaluation of the Safety, Tolerability, Efficacy and Activity of AMX0035, a Fixed Combination of Phenylbutyrate (PB) and Tauroursodeoxycholic Acid (TUDCA), for Treatment of Amyotrophic Lateral Sclerosis (ALS)
Phase:  II
Principal investigator: Vu, Tuan
Department: Neurology
Sponsor: Amylyx
Opening date: 4/18/2018

Title:  A phase 2, Multicenter, Open-Label Study to Assess PK/PD of SEG101 (crizanlizumab), with or without Hydroxyurea/Hydroxycarbamide, in Adult Sickle Cell Patients with Vaso-Occlusive Crisis
Phase:  II
Principal investigator: Rico, Juan
Department: Pediatrics
Sponsor: Novartis
Opening date: 4/13/2018 

Title:  A Study of EZN-2279 (Polyethylene Glycol Recombinant Adenosine Deaminase [PEG-rADA]) Administered as a Weekly Intramuscular Injection in Patients With Adenosine Deaminase (ADA)-Deficient Combined Immunodeficiency
Phase:  III
Principal investigator: Walter, Jolan
Department: Pediatrics
Sponsor: Leadiant Biosciences
Opening date: 4/4/2018

Title:  A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of RA101495 in Subjects with Generalized Myasthenia Gravis
Phase:  II
Principal investigator: Vu, Tuan
Department: Neurology
Sponsor: Ra Pharma
Opening date: 3/28/2018

Title:  A Multicenter, Prospective, Double-Blind, Randomized, Placebo-Controlled, Phase 3 Study of BB3 to Reduce the Severity of Delayed Graft Function in Recipients of a Deceased Donor Kidney
Phase:  III
Principal investigator: Jarmi, Tambi
Department: Internal Medicine
Sponsor: TGH
Opening date: 3/26/2018  

Title:  An Extension Study of ABBV-8E12 in Progressive Supranuclear Palsy (PSP)
Phase:  II
Principal investigator: Zesiewicz, Theresa
Department: Neurology
Sponsor: Abbvie
Opening date: 3/16/2018 

Title:  A Prospective Outcome Study on Patients with Profound Combined Immunodeficiency
Phase:  N/A
Principal investigator: Walter, Jolan
Department: Pediatrics
Sponsor: Medical Center University of Freiburg
Opening date: 3/12/201 

Title:  A Phase 3, Twelve-week, Multi-Center, Multinational, Randomized, Double-Blind, Double-Dummy, Parallel Group Study to Determine the Efficacy, Safety and Tolerability of P2B001 Once Daily Compared to its Individual Components in Subjects With Early Parkinson’s Disease and to a Calibration Arm of Pramipexole ER
Phase:  III
Principal investigator: Hauser, Robert
Department: Neurology
Sponsor: Pharma Two B
Opening date: 3/6/2018 

Title:  Open-label, single-arm, multiple-dose safety, titration, and pharmacokinetic study of AFREZZA® in pediatric subjects ages 4 to 17 years with type 1 diabetes mellitus
Phase:  II
Principal investigator: Rodriguez, Henry
Department: Diabetes Center
Sponsor: MannKind Corp.
Opening date: 2/28/2018 

Title:  Open-Label Extension Study to Evaluate the Long Term Safety and Efficacy of SPN-812 ER for the Treatment of Pediatric Patients with Attention Deficit/Hyperactivity Disorder (ADHD).
Phase:  II/III
Principal investigator: Fallon, Daniel
Department: Psychiatry
Sponsor: Supernus Pharmaceuticals
Opening date: 2/19/2018 

Title:  Phenotypic, Genotypic, and Functional Characterization of Primary Immune Deficiencies
Phase:  N/A
Principal investigator: Leiding, Jennifer
Department: Pediatrics
Sponsor: Horizon
Opening date: 2/12/2018 

Title:  Assessing Relationships Between Cognitive Function and Brain Atrophy in MS Patients
Phase:  I
Principal investigator: Robertson, Derrick
Department: Neurology
Sponsor: Prime Education, Inc.
Opening date: 1/16/2018 

Title:  A randomized, subject- and investigator-blinded, placebo-controlled, multi-center, multiple dose study to assess the efficacy and safety of CJM112 in patients with inadequately controlled moderate to severe asthma
Phase:  II
Principal investigator: Casale, Thomas
Department: Internal Medicine
Sponsor: Novartis
Opening date: 1/11/2018

Title:  A Clinical Study to Demonstrate Safety and Efficacy of E7777 in Persistent or Recurrent Cutaneous T-Cell Lymphoma
Phase:  III
Principal investigator: Seminario-Vidal, Lucia
Department: Dermatology
Sponsor: Eisai
Opening date: 1/3/2018

Title:  TAAA Debranching System comprised of the Thoracic Bifurcation and the Visceral Manifold
Phase:  I
Principal investigator: Shames, Murray
Department: Surgery
Opening date: 12/4/2017

Title:  Multicenter 1 -Year Observational Study of Patients Who Are Initiating Brivaracetam
Phase:  I
Principal investigator: Benbadis, Selim
Department: Neurology
Sponsor: UCB Biosciences
Opening date: 12/4/2017 

Title:  A phase III randomised, double-blind trial to evaluate efficacy and safety of once daily empagliflozin 10 mg compared to placebo, in patients with chronic Heart Failure with preserved Ejection Fraction (HFpEF)
Phase:  III
Principal investigator: Labovitz, Arthur
Department: Cardiology
Sponsor: Boehringer Ingelheim Pharmaceuticals (BIPI)
Opening date: 12/4/2017

Title:  A Randomized, Double-Blind, Placebo-Controlled, Phase IIa, Parallel Group, Two-Cohort Study to Define the Safety, Tolerability, Clinical and Exploratory Biological Activity of the Chronic Administration of Nilotinib in Participants with Parkinson’s Disease
Phase:  IIa
Principal investigator: Hauser, Robert
Department: Neurology
Sponsor: Northwestern University
Opening date: 12/4/2017

Title:  A multicenter, randomized, double-blind, placebo controlled, parallel group clinical study investigating the efficacy, tolerability, and safety of continuous subcutaneous ND0612 infusion Given as adjunct treatment to oral levOdopa in patients with Parkinson’s Disease with motor fluctuations (iNDiGO)
Phase:  III
Principal investigator: Hauser, Robert
Department: Neurology
Sponsor: NeuroDerm Ltd.
Opening date: 11/30/2017 

Title:  A Phase 1/2, Open-Label, Adaptive, Dose-Ranging Study to Assess the Safety and Tolerability of SB-525 (recombinant AAV2/6 human Factor 8 Gene Therapy) in Adult Subjects with Severe Hemophilia A
Phase:  I/II
Principal investigator: Visweshwar, Nathan
Department: Internal Medicine
Sponsor: Sangamo Therapeutics
Opening date: 11/30/2017

 Title:  A Phase 2b, Randomized, Double-Blind, Placebo-Controlled, Dose-Optimization Study to Assess the Safety, Tolerability, and Efficacy of NBI-98854 for the Treatment of Pediatric Subjects with Tourette Syndrom
Phase:  IIb
Principal investigator: Murphy, Tanya
Department: Pediatrics
Sponsor: Neurocrine Biosciences
Opening date: 11/30/2017

 Title:  Real-World AR101 Market-Supporting Experience Study in Peanut-Allergic Children, Active Treatment Arm Open-Label Extension Study (RAMSES OLE)
Phase:  III
Principal investigator: Casale, Thomas
Department: Internal Medicine
Sponsor: Aimmune Therapeutics, Inc.
Opening date: 11/30/2017

Title:  A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Pharmacokinetics, and Pharmacodynamics of BIIB054 in Subjects with Parkinson’s Disease
Phase:  IIa
Principal investigator: Hauser, Robert
Department: Neurology
Sponsor: Biogen Idec
Opening date: 11/28/2017

Title:  A Randomized, Double-Blind, Controlled, Parallel Group Study to Evaluate the  Efficacy and Safety of FLX-787-ODT for Treatment of  Muscle Cramps in Adult Subjects with Charcot-Marie-Tooth Disease
Phase:  I
Principal investigator: Vu, Tuan
Department: Neurology
Sponsor: Flex Pharma, Inc.
Opening date: 11/28/2017

Title:  A Phase 3, Randomized, Double-blind, Multicenter, Parallel-group, Placebo-controlled, Fixed-dose Safety and Efficacy Study of SPD489 Compared with Placebo in Preschool Children Aged 4-5 Years with Attention-deficit/Hyperactivity Disorder
Phase:  III
Principal investigator: Murphy, Tanya
Department: Pediatrics
Sponsor: Shire
Opening date: 11/28/2017

Title:  A Phase 3, Open-label, Multicenter, 12-Month Safety and Tolerability Study of SPD489 in Preschool Children Aged 4-5 Years Diagnosed with Attention-deficit/Hyperactivity Disorder
Phase:  III
Principal investigator: Murphy, Tanya
Department: Pediatrics
Sponsor: Shire
Opening date: 11/28/2017

Title:  Protocol Title  SPIRIT 2: An International Phase 3 Randomized, Double Blind, Placebo-Controlled Efficacy and Safety Study to Evaluate Relugolix Administered with and without Low-Dose Estradiol and Norethindrone Acetate in Women with Endometriosis-Associated Pain
Phase:  III
Principal investigator: Imudia, Anthony
Department: OB/GYN
Sponsor: Myovant Sciences
Opening date: 11/22/2017

Title:  An International Phase 3 Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study to Evaluate Relugolix Co-Administered with and without Low-Dose Estradiol and Norethindrone Acetate in Women with Heavy Menstrual Bleeding Associated with Uterine Fibroids
Phase:  III
Principal investigator: Imudia, Anthony
Department: OB/GYN
Sponsor: Myovant Sciences
Opening date: 11/22/2017 

Title:  Multicenter, Prospectively Defined Observational Registry With Retrospective Data Collection, Evaluating Premature and Term-Near-Term Neonates With Pulmonary Hypertension Receiving Inhaled Nitric Oxide via Invasive or Noninvasive Ventilator Support at U.S. Centers
Phase:  Observational
Principal investigator: Maheshwari, Akhil
Department: Pediatrics
Sponsor: Mallinckrodt Pharmaceuticals
Opening date: 11/21/2017

Title:  A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Trial of X4P-001 in Patients with Mutations of CXCR4 Associated with a Primary Immunodeficiency (WHIM Syndrome)
Phase:  II/III
Principal investigator: Walter, Jolan
Department: Pediatrics
Sponsor: X4 Pharmaceuticals
Opening date: 11/15/2017

Title:  Evaluation of SPN-812 ER 200 and 400 mg Efficacy and Safety in Children with ADHD – A Double-Blind, Placebo-Controlled, Pivotal Trial
Phase:  III
Principal investigator: Fallon, Daniel
Department: Psychiatry
Sponsor: Supernus Pharmaceuticals
Opening date: 11/3/2017

Title:  Evaluation of SPN-812 ER 400 and 600 mg Efficacy and Safety in Adolescents with ADHD – A Double-Blind, Placebo-Controlled, Pivotal Trial
Phase:  III
Principal investigator: Fallon, Daniel
Department: Psychiatry
Sponsor: Supernus Pharmaceuticals
Opening date: 11/3/2017

Title:  A Phase 3, Randomized, Double-Blind, Study Comparing ABT-494 to Placebo in Subjects with Active Psoriatic Arthritis Who Have a History of Inadequate Response to at Least One Biologic Disease Modifying Anti-Rheumatic Drug
Phase:  III
Principal investigator: Carter, John
Department: Internal Medicine
Sponsor: Abbvie
Opening date: 10/31/2017 

Title:  A Double-blind, Randomized, Placebo-controlled Study to Evaluate the Efficacy and Safety of Intranasal Esketamine in Addition to Comprehensive Standard of Care for the Rapid Reduction of the Symptoms of Major Depressive Disorder, Including Suicidal Ideation, in Subjects Assessed to be at Imminent Risk for Suicide
Phase:  III
Principal investigator: Currier, Glenn
Department: Psychiatry
Sponsor: Janssen
Opening date: 10/31/2017

Title:  A Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Testicular Safety of Filgotinib in Adult Males with Moderately to Severely Active Ulcerative Colitis
Phase:  II
Principal investigator: Marcet, Jorge
Department: Surgery
Sponsor: Gilead
Opening date: 10/24/2017 

Title:  A Multicenter, Open-Label, Long-Term Safety Study of AR101 Characterized Oral Desensitization Immunotherapy in Subjects who Participated in a Prior AR101 Study
Phase:  I
Principal investigator: Casale, Thomas
Department: Internal Medicine
Sponsor: Aimmune Therapeutics, Inc.
Opening date: 10/24/2017 

Title:  A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel-Arm Study to Evaluate Efficacy, Tolerability, and Pharmacokinetics of Multiple Doses of Oral TAK-831 in Adult Subjects With Friedreich Ataxia
Phase:  II
Principal investigator: Zesiewicz, Theresa
Department: Neurology
Sponsor: Takeda
Opening date: 10/19/2017

Title:  UbLiTuximab In Multiple Sclerosis Treatment Effects (ULTIMATE II STUDY)
Phase:  III
Principal investigator: Robertson, Derrick
Department: Neurology
Sponsor: TG Therapeutics
Opening date: 10/16/2017

 Title:  VOLTAIRE-X: Pharmacokinetics, safety, immunogenicity and efficacy of BI 695501 versus Humira® in patients with moderate to severe chronic plaque psoriasis: a randomized, double-blind, parallel-arm, multiple-dose, active comparator trial.
Phase:  III
Principal investigator: Patel, Nishit
Department: Dermatology
Sponsor: Boehringer Ingelheim Pharmaceuticals (BIPI)
Opening date: 10/13/2017

Title:  A clinical investigation to study the effect of Exufiber Ag+ and other gelling fibre dressings on wound exudate and bioburden in medium to high exuding wound.
Phase:  Device
Principal investigator: Davis, Donald
Department: Surgery
Sponsor: Mölnlycke Health Care
Opening date: 10/12/2017

Title:  A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Escalation Study With an Open-Label Phase to Examine the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of TAK-935 as an Adjunctive Therapy in Subjects With Developmental and/or Epileptic Encephalopathies
Phase:  I
Principal investigator: Benbadis, Selim
Department: Neurology
Sponsor: Takeda
Opening date: 10/10/2017

Title:  A Phase 2, Open Label Extension Study To Investigate the Long-term Safety and Tolerability of PF-06649751 in Subjects With Motor Fluctuations Due To Parkinson’s Disease
Phase:  II
Principal investigator: Hauser, Robert
Department: Neurology
Sponsor: Pfizer
Opening date: 10/10/2017

Title:  Effect of MD1003 in progressive multiple sclerosis: a randomized double blind placebo controlled study
Phase:  III
Principal investigator: Robertson, Derrick
Department: Neurology
Sponsor: MEDDAY Pharmaceuticals
Opening date: 10/6/2017

Title:  A Phase 3, Randomized, Double-Blind, Study Comparing ABT-494 to Placebo and to Adalimumab in Subjects with Active Psoriatic Arthritis Who Have a History of Inadequate Response to at Least One Non-Biologic Disease Modifying Anti-Rheumatic Drug (DMARD) – SELECT – PsA 1
Phase:  III
Principal investigator: Carter, John
Department: Internal Medicine
Sponsor: Abbvie
Opening date: 10/5/2017 

Title:  Parallel-Group, Placebo-Controlled Randomized Study Investigating the Effect of Intravenous Iso-osmolar Iodinated Contrast Material Iodixanol (Visipaque™ Injection 320 mgI/mL) on Renal Function in adults with Chronic Kidney Disease (CKD) Stage III or Stage IV Who Have Undergone Endovascular Aneurysm Repair (EVAR)
Phase:  IV
Principal investigator: Shames, Murray
Department: Surgery
Sponsor: GE Healthcare
Opening date: 10/4/2017

Title:  A Phase 3, Double-Blind, Randomized, Multicenter, Controlled Study to Evaluate the Immunogenicity, Safety, and Tolerability of VARIVAX™ Passage Extension 34 (PE34)Process Administered Concomitantly with M-M-R™ II
Phase:  III
Principal investigator: Soylu, Lana
Department: Pediatrics
Sponsor: Merck
Opening date: 10/4/2017 

Title:  A Phase 3 Study to Compare the Efficacy and Safety of Humacyte’s Human Acellular Vessel with that of an Autologous Arteriovenous Fistula in Subjects with End-Stage Renal Disease
Phase:  III
Principal investigator: Illig, Karl
Department: Surgery
Sponsor: Humacyte, Inc.
Opening date: 10/3/2017

 Title:  An Open-Label, Repeat-Dose Pharmacokinetics Study of NRL-1 in Epilepsy Subjects Under Seizure and Normal Conditions
Phase:  I
Principal investigator: Benbadis, Selim
Department: Neurology
Sponsor: Neurelis
Opening date: 9/21/2017 

Title:  The VALUE Study: VAlidation of a Lower cost aneUploidy scrEen
Phase:  N/A
Principal investigator: Odibo, Anthony
Department: OB/GYN
Sponsor: Women & Infants Hospital of Rhode Island
Opening date: 9/21/2017

Title:  A Phase 2a, Double-Blind, Placebo-Controlled Two-Part Study To Investigate the Safety and Efficacy of Increasing Doses Of DNS-7801 In Parkinson’s Disease (PD) Subjects With Motor Fluctuations
Phase:  IIa
Principal investigator: Hauser, Robert
Department: Neurology
Sponsor: Dart NeuroScience
Opening date: 9/21/2017

Title:  A Phase 2, Multi-Center, Double-Blind, Randomized, Dose-Ranging, Placebo-Controlled Study to Evaluate the Efficacy, Safety and Tolerability of CK-2127107 in Patients With Amyotrophic Lateral Sclerosis (ALS)
Phase:  II
Principal investigator: Vu, Tuan
Department: Neurology
Sponsor: Cytokinetics, Inc.
Opening date: 9/19/2017

Title:  A Multicenter, Open-Label Study to Evaluate the Safety and Tolerability of Tozadenant as Adjunctive Therapy in Levodopa-Treated Patients with Parkinson’s Disease Experiencing End of Dose “Wearing-Off”
Phase:  III
Principal investigator: Hauser, Robert
Department: Neurology
Sponsor: Biotie Therapies
Opening date: 9/18/2017

 Title:  A Phase 3, Open-label, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR
Phase:  III
Principal investigator: Patel, Kapil
Department: Internal Medicine
Sponsor: TGH
Opening date: 9/14/2017

Title:  Real‐World Evaluation Screening Study and Registry of Dyskinesia in Patients Taking Antipsychotic Agents (RE‐Kinect)
Phase:  Registry
Principal investigator: Fils, Jean
Department: Psychiatry
Sponsor: Neurocrine Biosciences
Opening date: 9/1/2017

Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Intravenously Administered BMS-986168 in Participants With Progressive Supranuclear Palsy
Phase: IIb
Principal investigator: Zesiewicz, Theresa
Department: Neurology
Sponsor: Bristol-Myers Squibb
Opening date: 8/24/2017

Title: A Randomized, Double-Blind, Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of FLX-787-ODT (orally disintegrating tablet) for Treatment of Muscle Cramps in Adult Subjects With Motor Neuron Disease
Phase: II
Principal investigator: Vu, Tuan
Department: Neurology
Sponsor: Flex Pharma, Inc.
Opening date: 8/24/2017

Title: A Randomized, Crossover, Open-Label, Multiple Dose, Pivotal Pharmacokinetic Bioequivalence Study
Comparing Paliperidone Palmitate Extended-Release IM 156 mg/1 mL (100 mg eq) With Invega Sustenna®
(U.S Product Reference) in Subjects with Schizophrenia or Schizoaffective Disorder
Phase: Bioequivalence with pharmacokinetics endpoints
Principal investigator: Currier, Glenn
Department: Psychiatry
Sponsor: PharmaScience
Opening date: 8/24/2017

Title: A Pilot, Prospective, Randomized, Controlled, Multicenter Technical Feasibility Clinical Study Comparing Standard Anastomosis Closure Technique to Standard Closure Techniques Plus Sylys® Surgical Sealant
Phase: I
Principal investigator: Marcet, Jorge
Department: Surgery
Sponsor: Cohera Medical
Opening date: 8/22/2017

Title: A Multicenter, International, Open-Label Safety Study of ND0612, a Solution of Levodopa/Carbidopa Delivered Via a Pump System as a Continuous Subcutaneous Infusion in Subjects With Advanced Parkinson’s Disease
Phase: IIb
Principal investigator: Hauser, Robert
Department: Neurology
Sponsor: NeuroDerm Ltd.
Opening date: 8/18/2017

Title: A Multicenter, Randomized, Investigator-and Subject-Blind, Placebo-Controlled, Treatment Sequence Study Evaluating the Safety, Tolerability and Efficacy of UCB7665 in Subjects With Moderate to Severe Myasthenia Gravis
Phase: IIa
Principal investigator: Vu, Tuan
Department: Neurology
Sponsor: UCB Biosciences
Opening date: 8/17/2017

Title: Evaluation of the Safety, Tolerability, Efficacy and Activity of AMX0035, a Fixed Combination of Phenylbutyrate (PB) and Tauroursodeoxycholic Acid (TUDCA), for Treatment of Amyotrophic Lateral Sclerosis (ALS)
Phase: II
Principal investigator: Vu, Tuan
Department: Neurology
Sponsor: Amylyx
Opening date: 8/16/2017

Title: Safety and Efficacy of Hizentra in Pediatric Hematopoietic Stem Cell Recipients
Phase: N/A
Principal investigator: Sriaroon, Panida
Department: Pediatrics
Sponsor: Carolinas Healthcare
Opening date: 8/15/2017

Title: A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Etrolizumab as an Induction and Maintenance Treatment For Patients With Moderately to Severely Active Crohn’s Disease
Phase: III
Principal investigator: Marcet, Jorge
Department: Surgery
Sponsor: Roche
Opening date: 8/15/2017

Title: An Open-Label Extension and Safety Monitoring Study of Patients With Moderately to Severely Active Crohn’s Disease Previously Enrolled in the Etrolizumab Phase III Protocol GA29144
Phase: III
Principal investigator: Marcet, Jorge
Department: Surgery
Sponsor: Roche
Opening date: 8/15/2017

Title: An Open-Label Multicenter Study to Evaluate the Safety and Tolerability of Higher Infusion Parameters of Immune Globulin Subcutaneous (Human), 20% Liquid (Hizentra®) in Subjects With Primary Immunodeficiency
Phase: IV
Principal investigator: Sriaroon, Panida
Department: Pediatrics
Sponsor: CSL Behring
Opening date: 8/14/2017

Title: A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of CX-8998 for Essential Tremor
Phase: II
Principal investigator: Zesiewicz, Theresa
Department: Neurology
Sponsor: Cavion
Opening date: 8/14/2017

Title: A Double-Blind, Randomized, Placebo Controlled Study of the Efficacy and Safety of Three Doses of Orvepitant in Subjects With Chronic Refractory Cough
Phase: II
Principal investigator: Casale, Thomas
Department: Internal Medicine
Sponsor: NeRRe Therapeutics Ltd
Opening date: 8/11/2017

Title: An Open-Label, Expanded Access Protocol for Amifampridine Phosphate (3,4-Diaminopyridine Phosphate) Treatment in Patients with Lambert-Eaton Myasthenic Syndrome (LEMS), Congenital Myasthenic Syndrome and Downbeat Nystagmus
Phase: N/A
Principal investigator: Vu, Tuan
Department: Neurology
Sponsor: Catalyst Pharmaceuticals
Opening date: 8/9/2017

Title: A Phase 1 Study to Evaluate the Safety and Efficacy of 4 Transcranial Electromagnetic Treatment (TEMT) for the 5 Treatment of Alzheimer’s Disease.
Phase: I
Principal investigator: Smith, Amanda
Department: Psychiatry
Sponsor: NeuroEM
Opening date: 7/28/2017

Title: A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects With Crohn’s Disease
Phase: III
Principal investigator: Marcet, Jorge
Department: Surgery
Sponsor: Gilead
Opening date: 7/27/2017

Title: Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects With Ulcerative Colitis
Phase: III
Principal investigator: Marcet, Jorge
Department: Surgery
Sponsor: Gilead
Opening date: 7/27/2017

Title: A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Efficacy and Safety of Filgotinib in the Treatment of Small Bowel Crohn’s Disease (SBCD)
Phase: II
Principal investigator: Marcet, Jorge
Department: Surgery
Sponsor: Gilead
Opening date: 7/27/2017

Title: A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Efficacy and Safety of Filgotinib in the Treatment of Perianal Fistulizing Crohn’s Disease
Phase: II
Principal investigator: Marcet, Jorge
Department: Surgery
Sponsor: Gilead
Opening date: 7/27/2017

Title: An Open-Label, Randomized, Actual Use Study of Dupilumab Auto-Injector Device in Patients With Atopic Dermatitis
Phase: III
Principal investigator: Casale, Thomas
Department: Internal Medicine
Sponsor: Regeneron
Opening date: 7/25/2017

Title: A Randomized, Double-Blind, Placebo-Controlled, 52-Week Phase II Study to Evaluate the Efficacy of Intravenous RO7046015 (PRX002) in Participants With Early Parkinson’s Disease With a 52-Week Blinded Extension
Phase: II
Principal investigator: Hauser, Robert
Department: Neurology
Sponsor: Roche
Opening date: 7/25/2017

Title: An Open-Label, Multi-Center, Follow-Up Study Designed to Evaluate the Long-Term Effects of AP-CD/LD in Fluctuating Parkinson’s Disease Subjects Who Completed Study IN 11 004
Phase: IIIb
Principal investigator: Hauser, Robert
Department: Neurology
Sponsor: Intec Pharma
Opening date: 7/20/2017

Title: A Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Evaluate Safety, Tolerability and Efficacy on LDL-C of Evolocumab (AMG 145) in Subjects With HIV and With Hyperlipidemia and/or Mixed Dyslipidemia
Phase: IIIb
Principal investigator: Morano, Jamie
Department: Internal Medicine
Sponsor: Amgen
Opening date: 7/17/2017

Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of the Efficacy and Safety of Lemborexant in Subjects With Irregular Sleep-Wake Rhythm Disorder and Mild to Moderate Alzheimer’s Disease Dementia
Phase: II
Principal investigator: Fils, Jean
Department: Psychiatry
Sponsor: Eisai
Opening date: 7/17/2017

Title: A Multicenter, Randomized, Double Blind, Placebo-Controlled Parallel Group, Pilot Study to Assess the Efficacy and Safety of H.P. Acthar® Gel in Subjects With Relapsing-Remitting Multiple Sclerosis
Phase: IV
Principal investigator: Robertson, Derrick
Department: Neurology
Sponsor: Mallinckrodt Pharmaceuticals
Opening date: 7/14/2017

Title: A Randomized, Double-blind, Placebo-Controlled Phase II Study to Evaluate the Safety, Efficacy and Pharmacokinetics of ARGX-113 in Patients with Myasthenia Gravis Who Have Generalized Muscle Weakness
Phase: II
Principal investigator: Vu, Tuan
Department: Neurology
Sponsor: Argenx
Opening date: 7/11/2017

Title: Multicenter, Non-Comparative Extension to Study AC-058B301, to Investigate the Long-Term Safety, Tolerability and Control of Disease of Ponesimod 20 mg in Subjects With Relapsing Multiple Sclerosis
Phase: III
Principal investigator: Robertson, Derrick
Department: Neurology
Sponsor: Actelion
Opening date: 7/11/2017

Title: A Phase 3, Open-Label, Randomized, Multicenter, Controlled Trial to Evaluate the Pharmacokinetics Andpharmacodynamics of Edoxaban and to Compare the Efficacy and Safety of Edoxaban With Standard of Care Anticoagulant Therapy in Pediatric Subjects From Birth to Less Than 18 Years of Age With Confirmed Venous Thromboembolism (VTE)
Phase: III
Principal investigator: Rico, Juan
Department: Pediatrics
Sponsor: Daiichi Sankyo
Opening date: 6/29/2017

Title: A Phase 2a, Double-Blind, Placebo-Controlled, Randomized Withdrawal Proof of Concept Study Evaluating the Activity, Safety, Tolerability, and Pharmacokinetics of SAGE-217 Oral Solution in the Treatment of Subjects With Essential Tremor (ET)
Phase: IIa
Principal investigator: Zesiewicz, Theresa
Department: Neurology
Sponsor: SAGE Therapeutics, Inc.
Opening date: 6/23/2017

Title: Combined Phase 3, Double-blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects With Moderately to Severely Active Crohn’s Disease
Phase: III
Principal investigator: Marcet, Jorge
Department: Surgery
Sponsor: Gilead
Opening date: 6/21/2017

Title: A Multicenter, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of H.P. Acthar® Gel in the Treatment of Subjects With Amyotrophic Lateral Sclerosis
Phase: IIb
Principal investigator: Vu, Tuan
Department: Neurology
Sponsor: Mallinckrodt Pharmaceuticals
Opening date: 6/21/2017

Title: A Phase 3, Multinational, Multicenter, Open-Label Study of the Safety, Tolerability, Efficacy, and Pharmacokinetics of ProMetic BioTherapeutics Immune Globulin Intravenous (Human) 10% in Adults and Children With Primary Immunodeficiency Diseases
Phase: III
Principal investigator: Leiding, Jennifer
Department: Pediatrics
Sponsor: ProMetic BioTherapeutics
Opening date: 6/19/2017

Title: Combined Phase 2b/3, Double-Blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects With Moderately to Severely Active Ulcerative Colitis
Phase: IIb
Principal investigator: Marcet, Jorge
Department: Surgery
Sponsor: Gilead
Opening date: 6/14/2017

Title: Randomized, Controlled Trial Comparing Separation of Components Repair With Retrorectus MatriStem Surgical Matrix versus Underlay or Overlay Biologic or Prosthetic Mesh for Open Ventral Hernia Repair
Phase: I
Principal investigator: Velanovich, Vic
Department: Surgery
Sponsor: ACell, Inc.
Opening date: 6/12/2017