A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics (PK) of RO7837195 in Participants With Moderately to Severely Active Ulcerative Colitis (UC)
Recruiting now · Phase 2 · Has a placebo group
Conditions studied: Ulcerative Colitis
In brief
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.
Key facts
- Study ID
- NCT06979336
- Run by
- Genentech, Inc.
- People needed
- 224
- Starts
- 2025-09-29
- Expected to finish
- 2028-10-31
- Last updated by the study team
- 2026-07-28
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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 is running
- Medical Associates Research Group, Inc. — San Diego, California, United States (enrolling)
- Peak Gastroenterology Associates — Colorado Springs, Colorado, United States (enrolling)
- Clinical Research of Osceola, LLC — Kissimmee, Florida, United States (enrolling)
- University of Chicago Medical Center — Chicago, Illinois, United States (enrolling)
- Intercity Gastroenterology — Fresh Meadows, New York, United States (enrolling)
- Monroe Biomedical Research — Monroe, North Carolina, United States (enrolling)
- University of Utah Hospitals & Clinics — Salt Lake City, Utah, United States (enrolling)
- Mater Misericordiae Limited — South Brisbane, Queensland, Australia (enrolling)
- HUWC - UFC - Hospital Universitrio Walter Cantdio - Universidade Federal do Cear — Fortaleza, Ceará, Brazil (enrolling)
- L2IP ?Instituto de Pesquisas Clínicas Ltda. — Brasília, Federal District, Brazil (enrolling)
- Chronos Pesquisa Clinica — Brasília, Federal District, Brazil (enrolling)
- Hospital Felicio Rocho — Belo Horizonte, Minas Gerais, Brazil (enrolling)
- Associao Paranaense de Cultura APC — Curitiba, Paraná, Brazil (enrolling)
- Centro Digestivo de Curitiba — Curitiba, Paraná, Brazil (enrolling)
- Hospital de Clnicas de Porto Alegre — Porto Alegre, Rio Grande do Sul, Brazil (enrolling)
- Hospital Ernesto Dornelles — Porto Alegre, Rio Grande do Sul, Brazil (enrolling)
- Newdata Clinical Trials — Aracaju, Sergipe, Brazil (enrolling)
- CECIP - Centro de Estudos Clínicos do Interior Paulista — Ja, São Paulo, Brazil (enrolling)
- Pesquisare Saude — Santo André, São Paulo, Brazil (enrolling)
- Kaiser Clinica — São José do Rio Preto, São Paulo, Brazil (enrolling)
- BR Trials - Ensaios Clnicos e Consultoria — São Paulo, São Paulo, Brazil (enrolling)
- CPQuali Pesquisa Clinica Ltda — So Paulo, São Paulo, Brazil (enrolling)
- Hospital Gloria DOr - Hospitais Integrados da Gavea S/A — Rio de Janeiro, Brazil (enrolling)
- London Digestive Disease Institute — London, Ontario, Canada (enrolling)
- Gastro Care Institute — Lancaster, California, United States (enrolling)
Full record on ClinicalTrials.gov
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