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
Genentech, Inc.
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.
Description
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 t…
Interventions
- DrugRO7837195
RO7837195 will be administered as per the schedule specified in the protocol.
- DrugRO7837195 Matched Placebo
RO7837195 matched placebo will be administered as per the schedule specified in the protocol.
Locations (82)
- Gastro Care InstituteLancaster, California
- Medical Associates Research Group, Inc.San Diego, California
- Peak Gastroenterology AssociatesColorado Springs, Colorado
- Clinical Research of Osceola, LLCKissimmee, Florida
- University of Chicago Medical CenterChicago, Illinois
- Intercity GastroenterologyFresh Meadows, New York