Recruiting
Phase 2

RO7837195

Sponsor:

Genentech, Inc.

Code:

NCT06979336

Conditions

Ulcerative Colitis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

RO7837195

RO7837195 Matched Placebo

Study Details

Brief summary:

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.

Conditions

Ulcerative Colitis

Study ID

NCT06979336

Start date

Sep 29, 2025

Status verified date

Aug, 2026

Completion date

Oct 31, 2028

Anticipated

Primary completion date

Aug 25, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

224 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: RO7837195 Dose Regimen 1

Participants will receive RO7837195 per the pre-defined dosing regimen during the 12-week induction and 40-week active treatment extension phases.

experimental: RO7837195 Dose Regimen 2

Participants will receive RO7837195 per the pre-defined dosing regimen during the 12-week induction and 40-week active treatment extension phases.

experimental: RO7837195 Dose Regimen 3

Participants will receive RO7837195 per the pre-defined dosing regimen during the 12-week induction and 40-week active treatment extension phases.

experimental: RO7837195 Dose Regimen 4

Participants will receive RO7837195 per the pre-defined dosing regimen during the 12-week induction and 40-week active treatment extension phases.

experimental: RO7837195 Matched Placebo/ 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.

Interventions

RO7837195

RO7837195 will be administered as per the schedule specified in the protocol.

RO7837195 Matched Placebo

RO7837195 matched placebo will be administered as per the schedule specified in the protocol.

Primary outcome measure

  • Percentage of Participants With Clinical Remission at Week 12 [ Time Frame: At Week 12 ]

Central Contacts and Locations

Central contacts

Reference Study ID Number: GA45977 https://forpatients.roche.com/ No attachments to email below.

888-662-6728 (U.S.)global-roche-genentech-trials@gene.com

Locations

Gastro Care Institute

Recruiting

Lancaster, California, United States, 93534

Medical Associates Research Group, Inc.

Recruiting

San Diego, California, United States, 92123

Peak Gastroenterology Associates

Recruiting

Colorado Springs, Colorado, United States, 80907

Clinical Research of Osceola, LLC

Recruiting

Kissimmee, Florida, United States, 34741

University of Chicago Medical Center

Recruiting

Chicago, Illinois, United States, 60637

Intercity Gastroenterology

Recruiting

Fresh Meadows, New York, United States, 11366

Monroe Biomedical Research

Recruiting

Monroe, North Carolina, United States, 28112

University of Utah Hospitals & Clinics

Recruiting

Salt Lake City, Utah, United States, 84132

London Digestive Disease Institute

Recruiting

London, Ontario, Canada, N6K 1M6

Hopital Maisonneuve-Rosemont d/b/a CIUSSS de l'Est-de-l'le-de-Montral

Recruiting

Montreal, Quebec, Canada, H1T 2M4

Clinique IMD

Recruiting

Montreal, Quebec, Canada, H3H 1E8

More Information

Sponsor

Genentech, Inc.

Last update posted

Aug 27, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-28. This information was provided to ClinicalTrials.gov by Genentech, Inc. on 2026-08-27. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.