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
Genentech, Inc.
224 participants
Sep 29, 2025
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria3
- 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 Criteria4
- 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
Interventions
RO7837195 will be administered as per the schedule specified in the protocol.
RO7837195 matched placebo will be administered as per the schedule specified in the protocol.
Locations(51)
View Full Details on ClinicalTrials.gov
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NCT06979336