This Phase III, randomized, double-blind, multicenter, induction and maintenance study will evaluate the safety and efficacy of Afimkibart (RO7790121) in pediatric participants with moderate to severe active ulcerative colitis (UC).
Bodyweight >= 10 kilogram (kg)
Confirmed diagnosis of UC
Moderately to severely active UC, defined as modified Mayo Score (mMS) or 5 to 9 points, including endoscopic score of 2 or 3, confirmed by centrally read endoscopy (flexible sigmoidoscopy or colonoscopy)
Demonstrated intolerance or inadequate response (IR) to one or more of the following categories of drugs: systemic corticosteroids, immunomodulators, and/or biologic therapies as outlined in the protocol
Monogenic disorder pertaining to infant onset inflammatory bowel disease (IBD)
Current diagnosis of Crohn's disease (CD), abdominal/intrabdominal/perianal fistula and/or abscess, indeterminant colitis, IBD-unclassified, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, or active diverticular disease
Presence of an ostomy or ileoanal pouch
Current diagnosis or suspicion of primary sclerosing cholangitis
Parallel
Afimkibart
DrugAfimkibart will be administered as IV infusion. Afimkibart will be administered as SC injection.
Percentage of Participants With Clinical Remission at Week 52
Change From Baseline in Pediatric Ulcerative Colitis Activity Index (PUCAI) Response
Percentage of Participants With PUCAI Remission
Change From Baseline in Tummy Ulcerative Colitis (TUMMY-UC) Scores
Partial Modified Mayo Score (pmMS)
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