Last updated 31 days ago
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics (PK) of RO7837195 in Participants With Moderately to Severely Active Ulcerative Colitis (UC)
224 patients around the world
Available in United States, Brazil
This study consists of up to 5-week screening period, a 12-week induction phase, a 40-week active treatment extension, and a safety follow-up period following the last dose of study treatment. The induction phase will be placebo-controlled and after its completion, all participants will receive treatment with active study drug, regardless of the treatment response.
Genentech, Inc.
1Research sites
224Patients around the world
This study is for people with
Ulcerative colitis
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- 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.
- 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.
Sites
Centro Digestivo de Curitiba - Instituto de Pesquisa Clínica
Recruiting
SponsorGenentech, Inc.
Study typeInterventional
Conditions
Ulcerative colitis
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06979336
