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

Launched by GENENTECH, INC. · May 16, 2025

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment called RO7837195 for people with moderately to severely active ulcerative colitis (UC), a condition that causes inflammation in the digestive tract. The goal is to see if RO7837195 is more effective than a placebo (a treatment that looks like the real medicine but has no active ingredients) in helping patients who haven't responded well to other treatments. The trial is currently not recruiting participants but will be looking for individuals aged 65 to 74 who have been diagnosed with ulcerative colitis for at least three months and have not had adequate relief from previous therapies.

To participate, individuals must have moderate to severe symptoms and must have tried other treatments without success. However, those who have had certain surgeries for UC or have been diagnosed with other similar conditions may not qualify. Participants in the trial can expect to receive either the new treatment or a placebo and will be closely monitored throughout the study to assess the safety and effectiveness of RO7837195. This research aims to provide new options for patients struggling with this challenging condition.

Gender

ALL

Eligibility 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