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Clinical Trials in the UK / NCT06029972
Active, not recruiting Phase 2

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

NCT06029972 · tracked via the Priya Life Science UK tracker
Sponsor
Gilead Sciences
Phase
Phase 2
Started
2023-12-05
Last updated
2026-09-11

Condition(s) studied

Ulcerative Colitis

Investigational drug(s) / intervention(s)

Tilpisertib FosmecarbilPlacebo

Tilpisertib Fosmecarbil: Tablets administered orally

Placebo: Tablets administered orally

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (102)

FacilityCityRegionStatus
GI Alliance Sun City Arizona
GastroSb Weight Loss Clinic Chula Vista California
Southern California Research Centers Coronado California
VVCRD Research Garden Grove California
UC San Diego Health System La Jolla California
Gastro Care Institute Lancaster California
Om Research LLC Lancaster California
University of California, Davis Sacramento California
University of California San Francisco San Francisco California
Luna Research Coral Gables Florida
University of Florida Gainesville Florida
The Medici Medical Research Hollywood Florida
Clinical Research of Osceola Kissimmee Florida
Florida Research Institute Largo Florida
GI PROS Research Naples Florida
Clinical One Research Orlando Florida
Digestive and Liver Center of Florida, LLC Orlando Florida
Advanced Medical Research Center Port Orange Florida
Corewell Health Grand Rapids Michigan
Mayo Clinic Rochester Minnesota
Gastroenterology Associates of North Mississippi Oxford Mississippi
Digestive Health Specialists Tupelo Mississippi
St. Charles Clinical Research St Louis Missouri
NYU Langone Long Island Clinical Research Associates Great Neck New York
Gastroenterology & Hepatology Specialists Inc Canton Ohio
The Ohio State University Wexner Medical Centre Columbus Ohio
Skyline Gastroenterology of West Tennessee Jackson Tennessee
Gastroenterology Research of Hill Country Boerne Texas
GI Alliance Lubbock Texas
Clinical Associates in Research Therapeutics of America San Antonio Texas
Gastroenterology Research of San Antonio San Antonio Texas
Tyler Research Institute, LLC Tyler Texas
Gastroenterology Associates of Tidewater Chesapeake Virginia
Emeritas Group Research Lansdowne Town Center Virginia
Gastroenterology Consultants of Southwest Virginia Roanoke Virginia
Sunshine Coast University Hospital Birtinya Queensland
Mater Adult Hospital South Brisbane Queensland
Princess Alexandra Hospital Woolloongabba Queensland
Royal Adelaide Hospital Adelaide South Australia
Queen Elizabeth Hospital Woodville South Australia

+ 62 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06029972 on ClinicalTrials.gov ↗ ← All trials in the UK