A Study of RO7837195 for Moderately to Severely Active Ulcerative Colitis

This study is looking into a new treatment called RO7837195 for people with moderately to severely active ulcerative colitis (UC), a chronic inflammatory bowel disease. You might be able to join if you are 18 or older, have had UC for at least three months, and your current treatments haven't worked well enough. The study will compare RO7837195 to a placebo (an inactive substance) to see how well it helps people achieve clinical remission (a period where symptoms are reduced or absent) after 12 weeks. The study also aims to understand the safety of RO7837195 and how your body processes it. The current status of this study is unclear, and it plans to enroll 224 participants.

Study design
This interventional study will involve comparing RO7837195 to a placebo in 224 participants. It includes a 12-week induction phase where some participants receive the drug and others receive placebo, followed by an active treatment extension for all participants.
What's involved
You would participate in a screening period of up to 5 weeks, followed by a 12-week induction phase, and then a 40-week active treatment extension. There will also be a safety follow-up period after your last dose of the study treatment.
Compensation
Not stated in the trial record.
Follow-up
There will be a safety follow-up period after the last dose of study treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06979336

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
Genentech, Inc.
~224 participants
Updated 2026-08-27 on ClinicalTrials.gov
What's tested:RO7837195RO7837195 Matched Placebo

At a glance

Recruiting sites
103 of 106 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percentage of Participants With Clinical Remission at Week 12
Measured over At Week 12
Ulcerative Colitis
106 sites across 62 states
Poland18
South Korea8
São Paulo6
Lombardy5
Guangdong3
California2
Federal District2
Paraná2
  • Clinical Trials · STUDY_DIRECTOR · Genentech, Inc.
Reference Study ID Number: GA45977 https://forpatients.roche.com/ No attachments to email below.
Email the study team

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Do you actually qualify for this trial?

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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
  • Percentage of Participants With Clinical Remission at Week 12At 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.