NCT06979336

A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics (PK) of RO7837195 in Participants With Moderately to Severely Active Ulcerative Colitis (UC)

A Phase IIb, Multicenter, Double-blind, Placebo-controlled Induction Study With an Active Treatment Extension to Assess the Efficacy, Safety, and Pharmacokinetics of RO7837195 in Patients With Moderately to Severely Active Ulcerative Colitis

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 224 (estimated)
• Sponsor: Genentech, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy of RO7837195 compared with placebo in participants with moderately to severely active ulcerative colitis for whom prior treatment with conventional and/or advanced therapies has failed.

Detailed description

This study consists of up to 5-week screening period, a 12-week induction phase, a 40-week active treatment extension, and a safety follow-up period following the last dose of study treatment. The induction phase will be placebo-controlled and after its completion, all participants will receive treatment with active study drug, regardless of the treatment response.

Conditions

• Ulcerative Colitis

Interventions

Type	Name	Description
DRUG	RO7837195	RO7837195 will be administered as per the schedule specified in the protocol.
DRUG	RO7837195 Matched Placebo	RO7837195 matched placebo will be administered as per the schedule specified in the protocol.

Timeline

• Start date: 2025-09-29
• Primary completion: 2027-08-25
• Completion: 2028-10-31
• First posted: 2025-05-18
• Last updated: 2026-04-03

Locations

64 sites across 13 countries: United States, Brazil, Canada, China, Czechia, France, Germany, Italy, Japan, Mexico, Poland, South Korea, United Kingdom

Regulatory

• FDA-regulated drug study