Digestive Health Clinical Research

Clinical Research Studies in Digestive Health

Biliary and Liver Disease

A Phase 3 Study to Evaluate the Efficacy and Safety of Pegozafermin in Subjects with Compensated Cirrhosis due to Metabolic Dysfunction-Associated Steatohepatitis (MASH)
Principal Investigator: Asma Siddique, MD
Status: Enrolling

ALTUS: PERFORMANCE OF A MULTI-TARGET HEPATOCELLULAR CARCINOMA (HCC) TEST IN SUBJECTS WITH INCREASED RISK
Principal Investigator: Asma Siddique, MD
Status: Enrolling

 

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A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO ASSESS THE EFFICACY AND SAFETY OF RIFAXIMIN SOLUBLE SOLID DISPERSION (SSD) TABLETS FOR THE DELAY OF ENCEPHALOPATHY DECOMPENSATION IN CIRRHOSIS (RED-C)
Principal Investigator: Blaire Burman, MD
Status: Closed to Enrollment

 

Clostridioides difficile (C. diff)

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED PHASE 3 STUDY OF VE303 FOR PREVENTION OF RECURRENT CLOSTRIDIOIDES DIFFICILE INFECTION: THE RESTORATIVE303 STUDY

Principal Investigator: Gautam Mankaney, MD
Status: Enrolling

 

Crohn's Disease

A Randomized, Double-blind, Placebo-Controlled Phase 3b Study to Evaluate the Shortand Long-term Efficacy and Safety of Dual Targeted Therapy With Intravenous Vedolizumab and Oral Upadacitinib Compared With Intravenous Vedolizumab Monotherapy for the Treatment of Adult Participants With Moderately to Severely Active Crohn’s Disease
Principal Investigator: Tim Zisman, MD
Status: Enrolling

 

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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 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 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: 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

Crohn's Disease: Risankizumab versus Ustekinumab for Subjects with 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

Familial Adenomatous Polyposis (FAP)

REC-4881-201 A PHASE 2, MULTICENTER, TRIAL TO EVALUATE THE EFFICACY, SAFETY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF REC-4881 IN PATIENTS WITH FAMILIAL ADENOMATOUS POLYPOSIS (FAP)
Principal Investigator: Gautam Mankaney, MD
Status: Enrolling

Gastroparesis

Examination of Programming with the Enterra® Therapy System in a Double-Blinded, randomized, Prospective Study In the Treatment of Nausea and Vomiting Symptoms using Gastric Electrical Stimulation
Principal Investigator: Pierre Blais, MD 
Status: Enrolling

Stricture

Paclitaxel Coated balloon for the Treatment of chronic bEnigN sTricture- Bowel
Principal Investigator: Joanna Law, MD
Status: Enrolling

 

Ulcerative Colitis

Casting Light on Urgency and Effectiveness of Advanced Therapies in Ulcerative Colitis (CLUES-UC): A Non-interventional, Observational Cohort Study of Mirikizumab and Other Biologics in Adult 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 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: 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