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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
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
Inclusion Criteria: * 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 Criteria: * 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
About the study
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.
What is being tested
- RO7837195 (drug)
- RO7837195 Matched Placebo (drug)
Sponsor: Genentech, Inc. · Participants: 224 · Started: Sep 29, 2025
Contact the study team
- Reference Study ID Number: GA45977 https://forpatients.roche.com/ No attachments to email below. · Phone: 888-662-6728 (U.S.)
Official record on ClinicalTrials.gov — NCT06979336
Locations in the U.S.
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.