Recruiting NCT06029972

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

Phase II Interventional Ulcerative Colitis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Tilpisertib Fosmecarbil, Placebo.
Who it may be relevant to: Registry conditions: Ulcerative Colitis. Basic parameters: 18 years — 75 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States, Australia, Austria, Belgium, Canada +9
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

Drug Tilpisertib Fosmecarbil
Tablets administered orally
Drug Placebo
Tablets administered orally

Primary outcome measures

Proportion of Participants Achieving Clinical Response Per Modified Mayo Clinic Score at Week 12 [Time frame: Week 12]

Secondary outcome measures (5)

Proportion of Participants Achieving Clinical Remission Per Modified Mayo Clinic Score at Week 12 [Time frame: Week 12]
Proportion of Participants Achieving Endoscopic Response at Week 12 [Time frame: Week 12]
Proportion of Participants Achieving Histologic Endoscopic Mucosal Improvement at Week 12 [Time frame: Week 12]
Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) [Time frame: First dose date up to Week 52 (responders) or Week 64 (non-responders) plus 30 days]
Percentage of Participants Experiencing Clinically Significant Laboratory Abnormalities [Time frame: First dose date up to Week 52 (responders) or Week 64 (non-responders) plus 30 days]

Eligibility criteria

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.

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Randomized
Model: Parallel assignment
Masking: Double blind
Primary purpose: Treatment