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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

RecruitingPhase 3Ages 2 Years - 17 YearsAllHoffmann-La Roche
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In plain words

What the trial is, and whether it could suit you

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).

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: * 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) Exclusion Criteria: * 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
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What it tests

  • Afimkibart
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Where

17 sites
NYU Langone Health
New York, United States
Mater Hospital Brisbane
South Brisbane, Australia
Royal Children's Hospital
Parkville, Australia
Perth Children's Hospital
Nedlands, Australia
Santa Casa de Misericordia de Porto Alegre
Porto Alegre, Brazil
CECIP - Centro de Estudos Clínicos do Interior Paulista
Jaú, Brazil
BR Trials - Pesquisa Clínica
São Paulo, Brazil
Centro de Investigación Clínica Acelerada, S.C
Mexico City, Mexico

…and 9 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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