A Phase III, Multicenter, Double-Blind, Placebo-Controlled, Treat-Through Study to Assess the Efficacy and Safety of Induction and Maintenance 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 treat-through study will evaluate the efficacy and safety of induction and maintenance 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. Placebo matching SC afimkibart.
Locations (362)
- Digestive Health Specialists of the Southeast (Gastroenterology Associates of Dothan) - DothanDothan, Alabama
- Mayo Clinic HospitalPhoenix, Arizona
- Arizona Digestive Health, P.C (ADH)Sun City, Arizona
- University of Arizona-CATS Research CenterTucson, Arizona
- Valley View Internal MedicineGarden Grove, California
- 310 Clinical ResearchInglewood, California