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Am I eligible for a clinical trial?

Each trial has specific eligibility criteria including age, condition, medical history, and current treatments. TrialConnect shows you trials that may match your situation, but only the trial team can confirm eligibility.

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

View on ClinicalTrials.gov ↗

At a glance

What the study gets you: Access to the study treatment being tested
Type of study: Interventional (receives a drug or procedure)
Time in hospital: In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention: Tilpisertib Fosmecarbil (drug), Placebo (drug)
How long the study runs: Study runs about 50 months (dates as stated)
About the drug or intervention: Tilpisertib Fosmecarbil — drug: Tablets administered orally · Placebo — drug: Tablets administered orally
Patient visit burden: Not specified by the sponsor

Type of study: Testing a treatment
Ages: 18 Years to 75 Years
Who: All
Number of participants: 176
Started: 2023-12-05
Last checked: 2026-09

Plain English Summary

What is this study?

• Testing a new treatment for ulcerative colitis
• Phase2 - 176 participants
• 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

Who can take part?

• Ages 18 Years to 75 Years
• Diagnosed with ulcerative colitis

Where?

• Bury - Fairfield General Hospital
• Cambridge - Cambridge University Hospitals NHS Foundation Trust
• London - Barts Health NHS Trust
• Norwich - Norfolk and Norwich University Hospital Nhs Foundation Trust
• +1 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

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.

Ulcerative Colitis

How this trial compares with your answers

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What we know so far

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

Age: 18 Years - 75 Years
Who can join: All genders

Treatment history

Treatments you must have had:

✓ hist
✓ to randomization if indicated by regional guidelines for individuals with UC

What the study is looking for

✓Individuals assigned male at birth, or nonpregnant, nonlactating individuals assigned female at birth, 18 to 75...
✓A surveillance colonoscopy for dysplasia is required prior to randomization if indicated by regional guidelines for...

Who cannot take part

✗Current diagnosis of Crohn's Disease (CD) or diagnosis of indeterminate colitis due to an enteric pathogen,...
✗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...
✗of randomization; or any infection requiring oral anti-infective therapy within 6 weeks of randomization.

See the full criteria

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.