Digestive Health Clinical Research

Clinical Research Studies in Digestive Health

Biliary and Liver Disease

A Multicenter, Prospective Study of EUS-Guided Transluminal Gallbladder Drainage in Patients with Acute Cholecystitis as an Alternative to Percutaneous Gallbladder Drainage
Principal Investigator: Shayan Irani, MD
Status: Closed to Enrollment

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, and Efficacy of GS-9674 in Non-Cirrhotic Subjects with Primary Sclerosing Cholangitis
Principal Investigator: Asma Siddique, MD
Status: Closed to Enrollment

Crohn's Disease

A Phase 2b Randomized, Double-blind, Active- and Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Induction and Maintenance Combination Therapy with Guselkumab and Golimumab in Participants with Moderately to Severely Active Crohn’s Disease
Principal Investigator: Tim Zisman, MD
Status: Enrolling

 

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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
Principal Investigator: Tim Zisman, MD
Status: Closed to Enrollment

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic Therapy
Principal Investigator: Tim Zisman, MD
Status: Closed to Enrollment

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn's Disease who Completed the Studies M14-431 or M14-433
Principal Investigator: Tim Zisman, MD
Status: Closed to Enrollment

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Assess the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease Who Failed Prior Biologic Treatment
Status: Closed to Enrollment

A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS-986165 in Subjects with Moderate to Severe Crohn's Disease
Principal Investigator: Tim Zisman, MD
Status: Closed to Enrollment

A Phase 2, Multicenter, Open-Label Extension (OLE) Study to Observe the Long-Term Efficacy, Safety, and Tolerability of Repeated Administration of Upadacitinib (ABT-494) in Subjects with Crohn's Disease
Principal Investigator: Tim Zisman, MD
Status: Closed to Enrollment

A Phase 3, Multicenter, Open-Label, Long-Term Extension Study to Evaluate the Long-Term Efficacy and Safety of Mirikizumab in Patients with Crohn's Disease
Principal Investigator: Tim Zisman, MD
Status: Closed to Enrollment

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
Principal Investigator: Tim Zisman, MD
Status: Closed to Enrollment

A phase III, randomized, double blind, parallel group, placebo controlled, international, multicentre 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
Principal Investigator: Tim Zisman, MD
Status: Closed to Enrollment

Crohn's Disease: Risankizumab versus Ustekinumab for Subjects with Crohn's Disease
Principal Investigator: Tim Zisman, MD
Status: Closed to Enrollment

GA29145-An Open-Label Extension and Safety Monitoring Study of Patients with Moderately to Severly Active Crohn's Disease Previously Enrolled in the Etrolizumab Phase II PRotocol GA29144
Principal Investigator: Tim Zisman, MD
Status: Closed to Enrollment

Phase 3b Open-label Study to Determine the Long-term Safety and Efficacy of Vedolizumab Subcutaneous in Subjects with Ulcerative Colitis and Crohn's Disease
Principal Investigator: Tim Zisman, MD
Status: Closed to Enrollment

Diverticulitis

Protocol for the Comparison of Surgery and Medicine on the Impact of Diverticulitis (COSMID) Trial
Principal Investigator: Val Simianu, MD
Status: Enrolling

Non Alcoholic Steatohepatitis (NASH)

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Semaglutide, and the Fixed-Dose Combination of Cilofexor and Firsocostat, Alone and in Combination, in Subjects with Compensated Cirrhosis due to NASH
Principal Investigator: Asma Siddique, MD
Status: Closed to Enrollment

A Phase 3, Double-Blind, Randomized, Long-Term, Placebo-Controlled, Multicenter Study Evaluating the Safety and Efficacy of Obeticholic Acid in Subjects with Nonalcoholic Steatoohepatitis
Principal Investigator: Asma Siddique, MD
Status: Closed to Enrollment

A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Obeticholic Acid in Subjects with Compensated Cirrhosis due to Nonalcoholic Steatohepatitis
Principal Investigator: Asma Siddique, MD
Status: Closed to Enrollment

Pancreatitis

SHARP Trial SpHincterotomy for Acute Recurrent Pancreatitis Trial
Principal Investigator: Andrew Ross, MD
Status: Enrolling

 

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NI03-001-A Phase 1, Single Dose PK and Safety Study with NI-03 Followed by a Phase 2, Randomized, Double-Blind, Parallel-Group Dose-Ranging Study to Evaluate the Safety and Efficacy of NI-03 Compared to Placebo in Subjects with Chronic Pancreatitis
Principal Investigator: Shayan Irani, MD
Status: Closed to Enrollment

Stent vs. Indomethacin for Preventing Post-ERCP Pancreatitis: The SVI Trial A Multicenter Randomized Non-inferiority Clinical Trial of Rectal Indomethacin Alone vs. Indomethacin & Prophylactic Pancrea
Principal Investigator: Joanna Law, MD
Status: Closed to Enrollment

Patients Having an Endoscopic Retrograde Cholangiopancreatography (ERCP)

Global Prospective Case Series using a Single-Use Duodenoscope
Principal Investigator: Andrew Ross, MD
Status: Closed to Enrollment

Initial Case Series with Exalt Single-Use Duodenoscope – Expanded User Experience
Principal Investigator: Andrew Ross, MD
Status: Closed to Enrollment

 

Ulcerative Colitis

A Phase 2b Randomized, Double-blind, Active- and Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Induction and Maintenance Combination Therapy with Guselkumab and Golimumab in Participants with Moderately to Severely Active Ulcerative Colitis
Principal Investigator: Tim Zisman, MD
Status: Enrolling

 

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A Multicenter, Randomized, Double-Blind, Placebo-Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis Who Responded to Induction Treatment in M16-067 or M16-065
Principal Investigator: Tim Zisman, MD
Status: Closed to Enrollment

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Ulcerative Colitis Who Have Failed Prior Biologic Therapy
Principal Investigator: Tim Zisman, MD
Status: Closed to Enrollment

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of ABT-494 for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis
Principal Investigator: Tim Zisman, MD
Status: Closed to Enrollment

A Phase 3 Multicenter, Open-Label Extension (OLE) Study to Evaluate the Long-Term Safety and Efficacy of ABT-494 in Subjects with Ulcerative Colitis (UC)
Principal Investigator: Tim Zisman, MD
Status: Closed to Enrollment

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
Principal Investigator: Tim Zisman, MD
Status: Closed to Enrollment

A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Safety and Efficacy of Ustekinumab Induction and Maintenance Therapy in Subjects with Moderate to Severe Ulcerative Colitis
Principal Investigator: James Lord, MD
Status: Closed to Enrollment

A Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately Active Ulcerative Colitis
Principal Investigator: Tim Zisman, MD
Status: Closed to Enrollment

An Open-Label Extension Study of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis
Principal Investigator: Tim Zisman, MD
Status: Closed to Enrollment