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RO7837195 for moderate to severe ulcerative colitis after other treatments failed

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

Phase 2 Interventional Genentech, Inc. · NCT06979336

This 12-week test will see if the experimental drug RO7837195 helps people with moderate to severe ulcerative colitis whose prior conventional or advanced treatments did not work or caused intolerable side effects.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment224 (estimated)
Ages18 Years and up
SexAll
SponsorGenentech, Inc. Industry-sponsored
Locations82 sites (Lancaster, California and 81 other locations)
Trial IDNCT06979336 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are people with moderately to severely active ulcerative colitis of at least three months' duration who have had inadequate response, loss of response, or intolerance to conventional or advanced UC therapies.

Not a fit: Patients with a history of extensive colonic resection or planned colectomy, a diagnosis of Crohn's disease or indeterminate colitis, or prior treatment targeting TL1A or with failed IL-12/23-targeted therapy are unlikely to benefit or are excluded from participation.

Why it matters

Potential benefit: If effective, RO7837195 could offer a new treatment option to induce remission and reduce inflammation in patients with ulcerative colitis who have not responded to existing therapies.

How similar studies have performed: Other biologic and small-molecule agents targeting inflammatory pathways have shown benefit in similar refractory UC populations, but TL1A-targeted approaches like RO7837195 are relatively new and have limited published clinical data to date.

Eligibility criteria

Show full inclusion / exclusion 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

Where this trial is running

Lancaster, California and 81 other locations

+32 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Ulcerative Colitis
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.