Tests RO7837195 against placebo in moderate to severe ulcerative colitis
Tests RO7837195 against placebo in adults with active ulcerative colitis.
Plain-language title generated from the registry record
Registry title: A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics (PK) of RO7837195 in Participants With Moderately to Severely Active Ulcerative Colitis (UC)
Key facts
- Where
- Busan, Daejeon, Gwangju, Seoul, and Wŏnju, South KoreaSee the 9 sites
- Phase
- Phase 2
Where in South Korea
- Inje University Haeundae Paik HospitalBusan, South KoreaTaking people
- The Catholic University of Korea, Daejeon ST.Mary's HospitalDaejeon, South KoreaTaking people
- Chosun University HospitalGwangju, South KoreaTaking people
- Asan Medical CenterSeoul, South KoreaTaking people
- Chung ang University HospitalSeoul, South KoreaTaking people
- Kangbuk Samsung HospitalSeoul, South KoreaTaking people
- Samsung Medical CenterSeoul, South KoreaTaking people
- The Catholic University of Korea, Eunpyeong St. Mary's HospitalSeoul, South KoreaTaking people
- Yonsei University Wonju Severance Christian HospitalWŏnju, South KoreaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Genentech, Inc.
- Trial code
- NCT06979336EU 2025-520690-39-00
- Record updated
- 27 October 2026
- Original description
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.Read full original descriptionShow less
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
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.
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; 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; Diagnosis of Crohn's disease or indeterminate colitis.