RO7837195 for moderate to severe ulcerative colitis after other treatments failed

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2, randomized interventional trial compares RO7837195 with placebo during a 12-week induction period in adults with moderately to severely active ulcerative colitis who have had inadequate response, loss of response, or intolerance to prior therapies. The overall program includes up to a 5-week screening period, a 12-week placebo-controlled induction, and a 40-week active treatment extension during which all participants receive the study drug, followed by a safety follow-up after the last dose. Key outcomes include clinical efficacy measures, safety and tolerability, and pharmacokinetic profiling of RO7837195. Participants are enrolled at several U.S. gastroenterology centers and must meet disease activity and prior-treatment failure criteria to qualify.

Why it matters

Who can join: the full rules

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

Where it's running

• Gastro Care Institute
  Lancaster, California, United States Recruiting
• Medical Associates Research Group, Inc.
  San Diego, California, United States Recruiting
• Peak Gastroenterology Associates
  Colorado Springs, Colorado, United States Recruiting
• Clinical Research of Osceola, LLC
  Kissimmee, Florida, United States Recruiting
• University of Chicago Medical Center
  Chicago, Illinois, United States Recruiting
• Intercity Gastroenterology
  Fresh Meadows, New York, United States Recruiting

+61 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Reference Study ID Number: GA45977 https://forpatients.roche.com/ No attachments to email below.
• Email: global-roche-genentech-trials@gene.com
• Phone: 888-662-6728 (U.S.)

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.