Skip to main content
TTrialFinder
TrialFinder is for informational purposes only and does not provide medical advice. Always talk to your doctor.
RECRUITINGPhase 2INTERVENTIONAL

Study of Tilpisertib Fosmecarbil in Participants With Moderately to Severely Active Ulcerative Colitis

A Phase 2, Double-Blinded, Randomized, Placebo-Controlled, Dose-Ranging Study Evaluating the Efficacy and Safety of GS-5290 in Participants With Moderately to Severely Active Ulcerative Colitis

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

The goal of this study is to learn if tilpisertib fosmecarbil (formerly known as GS-5290) is effective and safe in treating participants with moderate to severe ulcerative colitis. The study will compare participants in different treatment groups treated with tilpisertib fosmecarbil with participants treated with placebo. The primary objective of this study is to demonstrate the efficacy of tilpisertib fosmecarbil, compared to placebo control, in achieving Clinical Response at Week 12.

Who May Be Eligible (Plain English)

Key Who May Qualify: - Individuals assigned male at birth, or nonpregnant, nonlactating individuals assigned female at birth, 18 to 75 years of age based on the date of the screening visit. - Ulcerative colitis (UC) of at least 90-day duration before randomization confirmed by endoscopy and histology at any time in the past AND a minimum disease extent of 15 cm from the anal verge. Documentation of endoscopy and histology consistent with the diagnosis of UC must be available in the source documents prior to the initiation of screening. - Moderately to severely active UC as determined during screening with a modified Mayo Clinic Score based on the sum of Stool Frequency, Rectal Bleeding, and Endoscopic Finding of 5 to 9 points and an endoscopic subscore of 2 to 3 (determined by central reader). - Previous treatment history of approved UC therapy with at least one advanced therapy mechanisms of action but failure (ie, loss of response or lack of response) of no more than 3 different advanced therapy mechanisms of action. - A surveillance colonoscopy for dysplasia is required prior to randomization if indicated by regional guidelines for individuals with UC. Key Who Should NOT Join This Trial: - Current diagnosis of Crohn's Disease (CD) or diagnosis of indeterminate colitis due to an enteric pathogen, lymphocytic or collagenous colitis. - Individuals with disease limited to the rectum (ulcerative proctitis) during screening endoscopy. - Requirement for ongoing therapy with or prior use of any prohibited medications. - Active clinically significant infection, or any infection requiring hospitalization or treatment with intravenous anti-infectives within 8 weeks. of randomization; or any infection requiring oral anti-infective therapy within 6 weeks of randomization. - History of opportunistic infection. - Current diagnosis of acute severe colitis, fulminant colitis, or toxic megacolon. Note: Other protocol-defined Inclusion/Exclusion criteria may apply. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Key Inclusion Criteria: * Individuals assigned male at birth, or nonpregnant, nonlactating individuals assigned female at birth, 18 to 75 years of age based on the date of the screening visit. * Ulcerative colitis (UC) of at least 90-day duration before randomization confirmed by endoscopy and histology at any time in the past AND a minimum disease extent of 15 cm from the anal verge. Documentation of endoscopy and histology consistent with the diagnosis of UC must be available in the source documents prior to the initiation of screening. * Moderately to severely active UC as determined during screening with a modified Mayo Clinic Score based on the sum of Stool Frequency, Rectal Bleeding, and Endoscopic Finding of 5 to 9 points and an endoscopic subscore of 2 to 3 (determined by central reader). * Previous treatment history of approved UC therapy with at least one advanced therapy mechanisms of action but failure (ie, loss of response or lack of response) of no more than 3 different advanced therapy mechanisms of action. * A surveillance colonoscopy for dysplasia is required prior to randomization if indicated by regional guidelines for individuals with UC. Key Exclusion Criteria: * Current diagnosis of Crohn's Disease (CD) or diagnosis of indeterminate colitis due to an enteric pathogen, lymphocytic or collagenous colitis. * Individuals with disease limited to the rectum (ulcerative proctitis) during screening endoscopy. * Requirement for ongoing therapy with or prior use of any prohibited medications. * Active clinically significant infection, or any infection requiring hospitalization or treatment with intravenous anti-infectives within 8 weeks. of randomization; or any infection requiring oral anti-infective therapy within 6 weeks of randomization. * History of opportunistic infection. * Current diagnosis of acute severe colitis, fulminant colitis, or toxic megacolon. Note: Other protocol-defined Inclusion/Exclusion criteria may apply.

Treatments Being Tested

DRUG

Tilpisertib Fosmecarbil

Tablets administered orally

DRUG

Placebo

Tablets administered orally

Locations (20)

GI Alliance
Sun City, Arizona, United States
GastroSb Weight Loss Clinic
Chula Vista, California, United States
Southern California Research Centers
Coronado, California, United States
VVCRD Research
Garden Grove, California, United States
UC San Diego Health System
La Jolla, California, United States
Gastro Care Institute
Lancaster, California, United States
Om Research LLC
Lancaster, California, United States
United Medical Doctors
Murrieta, California, United States
University of California, Davis
Sacramento, California, United States
University of California San Francisco
San Francisco, California, United States
Amicis Research Center
Valencia, California, United States
Luna Research
Coral Gables, Florida, United States
University of Florida
Gainesville, Florida, United States
The Medici Medical Research
Hollywood, Florida, United States
Encore Medical Research, LLC
Hollywood, Florida, United States
Clinical Research of Osceola
Kissimmee, Florida, United States
Florida Research Institute
Largo, Florida, United States
Wellness Research Center
Miami, Florida, United States
IMIC Inc
Miami, Florida, United States
Reserka LLC
Miami, Florida, United States