This phase III, double-blind, multi-center treat-through study will evaluate the efficacy and safety of Afimkibart (also known as RO7790121) in children with moderately to severely active Crohn's Disease (CD).
Body weight >= 10 kilogram (kg)
Active CD confirmed by endoscopy (ileocolonoscopy)
Moderately to severely active CD, defined as a Pediatric Crohn's Disease Activity Index (PCDAI) score >= 30, and Simple Endoscopic Score Crohn's Disease (SES-CD) >=6 (or >=4 for isolated ileal disease) confirmed through centrally-read ileocolonoscopy
Inadequate response, loss of response, and/or intolerance to at least one of the following conventional therapies (aminosalicylates, corticosteroids and/or immunosuppressants) or advanced therapies (including anti-tumor necrosis factor, anti-interleukin, anti-integrin, or Janus Kinase (JAK) inhibitors)
Monogenic disorder pertaining to infant onset Inflammatory Bowel Disease (IBD)
History of >= 3 bowel resections: > 2 missing segments of the following five segments: terminal ileum, right colon, transverse colon, sigmoid and left colon, and rectum
Current diagnosis of ulcerative colitis (UC), abdominal/intraabdominal/perianal fistula and/or abscess, indeterminant colitis, IBD-unclassified, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, or active diverticular disease.
Symptomatic bowel strictures, fulminant colitis, or toxic megacolon
Parallel
Afimkibart
DrugAfimkibart will be administered as IV infusion. Afimkibart will be administered as SC injection.
Percentage of Participants With Clinical Remission per Pediatric Crohn's Disease Activity Index (PCDAI)
Percentage of Participants With Endoscopic Response
Percentage of Participants With Clinical Remission
Percentage of Participants With Clinical Response
Percentage of Participants With CDAI Remission
Change From Baseline in Fecal Calprotectin
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