Home › Trials › NCT06029972

Treatment of moderate to severe ulcerative colitis with tilpisertib fosmecarbil

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

Phase 2 Interventional Gilead Sciences · NCT06029972

This study is testing if a new treatment called tilpisertib fosmecarbil can help people with moderate to severe ulcerative colitis who haven't had success with other therapies.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment176 (estimated)
Ages18 Years to 75 Years
SexAll
SponsorGilead Sciences Industry-sponsored
Locations129 sites (Sun City, Arizona and 128 other locations)
Trial IDNCT06029972 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the effectiveness and safety of tilpisertib fosmecarbil in individuals with moderately to severely active ulcerative colitis. Participants will be randomly assigned to receive either the treatment or a placebo, with the primary goal of assessing clinical response at Week 12. The study will include individuals aged 18 to 75 who have a confirmed diagnosis of ulcerative colitis and have experienced inadequate response to previous therapies. The results will help determine if tilpisertib fosmecarbil can provide a new treatment option for this condition.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 18 to 75 with a confirmed diagnosis of moderately to severely active ulcerative colitis.

Not a fit: Patients who have not previously failed at least one advanced therapy for ulcerative colitis may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a new effective option for patients suffering from moderate to severe ulcerative colitis.

How similar studies have performed: Other studies have shown promise with similar therapeutic approaches, but the specific efficacy of tilpisertib fosmecarbil is still being evaluated.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Sun City, Arizona and 128 other locations

+79 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Ulcerative Colitis
Last reviewed 2026-06-10 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.