A Phase III, Multicenter, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Induction Therapy With RO7790121 in Patients With Moderately to Severely Active Crohn's Disease
Hoffmann-La Roche
Summary
This Phase III, multicenter, double-blind, placebo-controlled study will evaluate the efficacy and safety of induction therapy with Afimkibart (also known as RO7790121) in participants with moderately to severely active Crohn's disease (CD).
Eligibility
- Age range
- 16–80 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Confirmed diagnosis of CD * Moderately to severely active CD * Bodyweight \>= 40 kilogram (kg) * Demonstrated inadequate response, loss of response and/or intolerance to at least one protocol-specified conventional or advanced CD therapy * Males and females of childbearing potential must meet protocol criteria for contraception requirements Exclusion Criteria: * Current diagnosis of ulcerative colitis (UC) or indeterminate colitis, ischemic colitis, infectious colitis, radiation colitis, microscopic colitis * Participant with a history of \>= 3 bowel resections (\> 2 m…
Interventions
- DrugAfimkibart
Afimkibart will be administered as IV infusion. Afimkibart will be administered as SC injection.
- DrugPlacebo
Placebo matching IV afimkibart.
Locations (173)
- Sun City Clinical ResearchGlendale, Arizona
- Om Research LLCLancaster, California
- Hoag Memorial Hospital Presbyterian;Hoag Center for Research and EducationNewport Beach, California
- Empire Clinical ResearchPomona, California
- Stanford Medicine Outpatient CenterRedwood City, California
- Clinical Applications Laboratories, Inc.San Diego, California