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Study of Tilpisertib Fosmecarbil for Ulcerative Colitis

This study is testing a new drug called tilpisertib fosmecarbil to see if it's safe and effective for people with moderately to severely active ulcerative colitis (UC). You would receive either tilpisertib fosmecarbil or a placebo (an inactive substance). Researchers will compare these groups to see if the drug helps improve your UC symptoms. To join, you must be between 18 and 75 years old and have UC that has been confirmed by medical tests and affects at least 15 cm of your colon. The main goal is to see how many participants show a clinical response (improvement in symptoms) after 12 weeks. The study plans to enroll 176 participants, but its current recruitment status is unclear.

Study design
This interventional study plans to enroll 176 participants. It compares the effects of tilpisertib fosmecarbil tablets to a placebo.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome is measured at Week 12, indicating follow-up for at least that duration.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06029972

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

Recruiting
PHASE2Ages 18–75InterventionalTreatment
Gilead Sciences
~176 participants
Updated 2026-02-11 on ClinicalTrials.gov
What's tested:Tilpisertib FosmecarbilPlacebo

At a glance

Recruiting sites
102 of 129 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Proportion of Participants Achieving Clinical Response Per Modified Mayo Clinic Score at Week 12
Measured over Week 12

Conditions

Ulcerative Colitis

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Ulcerative Colitis

Where it's being run

129 sites across 32 states
Florida14
Japan12
Poland11
California10
Texas9
France8
South Korea8
Ohio5

Study leadership

  • Gilead Study Director · STUDY_DIRECTOR · Gilead Sciences

Who to contact

Gilead Clinical Study Information Center
[email protected]
1-833-445-3230 (GILEAD-0)
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Eligibility criteria

Inclusion

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.

Exclusion

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.
History of opportunistic infection.
Current diagnosis of acute severe colitis, fulminant colitis, or toxic megacolon.

What this trial measures

  • Proportion of Participants Achieving Clinical Response Per Modified Mayo Clinic Score at Week 12Week 12

    Clinical Response is defined as a decrease from baseline of ≥ 2 points and at least 30% in 3 components of the modified Mayo Clinic Score, Stool Frequency, Rectal Bleeding, and Endoscopic Findings, in addition to a ≥ 1 point decrease from baseline in the Rectal Bleeding subscore or Rectal Bleeding subscore of ≤ 1. The modified Mayo Clinic Score is a scoring system for assessment of UC activity and is composed of subscores from endoscopy (range: 0 to 3, where 0 = normal or inactive disease and 3 = severe disease \[spontaneous bleeding, ulceration\]), rectal bleeding (range: 0 to 3, where 0 = no blood seen and 3 = blood alone passes), and stool frequency (range: 0 to 3, where 0 = normal number of stools and 3 = at least 5 or more stools more than normal). Total score for modified Mayo Clinic Score ranges from 0 to 9 (sum of all subscores), with higher scores indicating higher disease activity.