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 Ulcerative Colitis
Hoffmann-La Roche
Summary
This Phase III, multicenter, double-blind, placebo-controlled study will evaluate the efficacy and safety of induction therapy with Afimkibart (RO7790121) compared with placebo in participants with moderately to severely active ulcerative colitis (UC).
Eligibility
- Age range
- 16–80 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Confirmed diagnosis of UC * Moderately to severely active UC assessed by mMS * Bodyweight \>= 40 kilogram (kg) * Up to date with colorectal cancer (CRC) screening performed according to local standards * Demonstrated inadequate response, loss of response and/or intolerance to at least one protocol-specified conventional or advanced UC therapy * Males and females of childbearing potential must meet protocol criteria for contraception requirements Exclusion Criteria: * Currently known complications of UC (e.g. fulminant colitis, toxic megacolon) * Current diagnosis of Cr…
Interventions
- DrugAfimkibart
Participants will receive afimkibart IV followed by afimkibart subcutaneous SC injection.
- DrugPlacebo
Placebo matching IV afimkibart. Placebo matching SC afimkibart.
Locations (199)
- Digestive Health Specialists of the Southeast (Gastroenterology Associates of Dothan) - DothanDothan, Alabama
- Mayo Clinic HospitalScottsdale, Arizona
- Arizona Digestive Health, P.C (ADH)Sun City, Arizona
- Om Research LLCApple Valley, California
- Valley View Internal MedicineGarden Grove, California
- Gastro Care AssociatesLancaster, California