NCT06290934

Study of GS-1427 in Participants With Moderately to Severely Active Ulcerative Colitis

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Dose-Ranging Study Evaluating the Efficacy and Safety of GS-1427 in Adult Participants With Moderately to Severely Active Ulcerative Colitis (UC)

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 228 (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 emvistegrast (formerly GS-1427) is effective in treating participants with moderate to severe ulcerative colitis. The study will compare participants in different treatment groups treated with emvistegrast with participants treated with placebo. The primary objective of this study is to assess the efficacy of emvistegrast, compared with placebo control, in achieving clinical response at Week 12.

Conditions

• Ulcerative Colitis

Interventions

Type	Name	Description
DRUG	emvistegrast	Administered orally
DRUG	Placebo-to-match emvistegrast	Administered orally

Timeline

• Start date: 2024-03-27
• Primary completion: 2026-03-04
• Completion: 2028-04-01
• First posted: 2024-03-04
• Last updated: 2026-04-09

Locations

181 sites across 22 countries: United States, Australia, Austria, Belgium, Canada, Czechia, France, Georgia, Germany, Hong Kong, Hungary, Italy, Malaysia, Moldova, New Zealand, Poland, Romania, Serbia, South Korea, Spain, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study