Status:
RECRUITING
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics (PK) of RO7837195 in Participants With Moderately to Severely Active Ulcerative Colitis (UC)
Lead Sponsor:
Genentech, Inc.
Conditions:
Ulcerative Colitis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 conventiona...
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 ind...
Eligibility Criteria
Inclusion
- Diagnosis of ulcerative colitis (UC) established at least 3 months
- Moderately to severely active UC assessed by mMS
- Inadequate response, loss of response, or intolerance to conventional or advanced therapies for UC
Exclusion
- Prior extensive colonic resection, subtotal or total colectomy, or planned surgery for UC
- Diagnosis of Crohn's disease or indeterminate colitis
- Treatment with an advanced therapy targeted at tumor necrosis factor-like cytokine 1A (TL1a)
- Inadequate response, loss of response, or intolerance to treatment of UC with an advanced therapy targeted at IL-12 and/or IL-23
Key Trial Info
Start Date :
September 29 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 31 2028
Estimated Enrollment :
224 Patients enrolled
Trial Details
Trial ID
NCT06979336
Start Date
September 29 2025
End Date
October 31 2028
Last Update
January 6 2026
Active Locations (27)
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1
Gastro Care Institute
Lancaster, California, United States, 93534
2
Medical Associates Research Group, Inc.
San Diego, California, United States, 92123
3
Peak Gastroenterology Associates
Colorado Springs, Colorado, United States, 80907
4
Clinical Research of Osceola, LLC
Kissimmee, Florida, United States, 34741