A Study to Assess the Pharmacokinetics, Effectiveness and Safety of Afimkibart for Induction and Maintenance Therapy in Children With Moderately to Severely Active Crohn's Disease
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CONTACT
Lead
Hoffmann-La Roche
Age
2–17
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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)
You may not be if
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
Presence of abdominal or perianal abscess
Current diagnosis or suspicion of primary sclerosing cholangitis
