A Phase 2 interventional study of RO7837195 and RO7837195 Matched Placebo in Ulcerative Colitis, sponsored by Genentech, Inc.. Recruiting at 108 sites in 15 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-28.
Sponsored by Genentech, Inc. · Phase 2, Interventional, and Treatment
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.
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.
Exclusion Criteria:
Participants will receive RO7837195 per the pre-defined dosing regimen during the 12-week induction and 40-week active treatment extension phases.
Drug: RO7837195
Participants will receive RO7837195 per the pre-defined dosing regimen during the 12-week induction and 40-week active treatment extension phases.
Drug: RO7837195
Participants will receive RO7837195 per the pre-defined dosing regimen during the 12-week induction and 40-week active treatment extension phases.
Drug: RO7837195
Participants will receive RO7837195 per the pre-defined dosing regimen during the 12-week induction and 40-week active treatment extension phases.
Drug: RO7837195
Participants will receive RO7837195 matched placebo and RO7837195 per the pre-defined dosing regimen during the 12-week induction and 40-week active treatment extension phases, respectively.
Drug: RO7837195 · Drug: RO7837195 Matched Placebo
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.
Percentage of Participants With Clinical Remission at Week 12
Clinical remission is defined as the Modified Mayo Score (mMS) of ≤ 2, including stool frequency subscore of ≤ 1, rectal bleeding subscore of 0, and endoscopy subscore of ≤ 1.
Time frame: At Week 12
Percentage of Participants With Clinical Response at Week 12
Clinical response is defined as decrease from baseline in the mMS by ≥2 and ≥ 30% reduction from baseline, with either a decrease of ≥1 in the rectal bleeding subscore or an absolute rectal bleeding subscore of ≤1.
Time frame: At Week 12
Percentage of Participants With Endoscopic Improvement at Week 12
Endoscopic improvement is defined as a Mayo endoscopy subscore of ≤ 1.
Time frame: At Week 12
Percentage of Participants With Endoscopic Remission at Week 12
Endoscopic remission is defined as a Mayo endoscopy subscore of 0.
Time frame: At Week 12
Number of Participants With Adverse Events (AEs)
Time frame: Up to Weeks 65
Serum Concentration of RO7837195
Time frame: Up to Weeks 65
Percentage of Participants With Anti-drug Antibodies to RO7837195
Time frame: Up to Weeks 65
Showing the first 100 of 108 sites across 15 countries.
Plan to share: Yes — For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing
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Genentech, Inc.