NCT06029972

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

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 176 (estimated)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Ulcerative Colitis

Interventions

Type	Name	Description
DRUG	Tilpisertib Fosmecarbil	Tablets administered orally
DRUG	Placebo	Tablets administered orally

Timeline

• Start date: 2023-12-05
• Primary completion: 2027-01-01
• Completion: 2028-02-01
• First posted: 2023-09-08
• Last updated: 2026-02-11

Locations

129 sites across 14 countries: United States, Australia, Austria, Belgium, Canada, France, Germany, Hungary, Italy, Japan, Poland, South Korea, Switzerland, United Kingdom

Regulatory

• FDA-regulated drug study