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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
100 patients around the world
Available in Brazil, Mexico, United States
Hoffmann-La Roche
2Research sites
100Patients around the world
This study is for people with
Crohn's disease
Moderate to severe crohn's disease
Requirements for the patient
To 17 Years
All Gender
Medical requirements
- 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.Presence of abdominal or perianal abscess.Current diagnosis or suspicion of primary sclerosing cholangitis.
Sites
CECIP Jau - Centro de Estudos Clínicos do Interior Paulista Ltda
Recruiting
FAICIC Clinical Research
Recruiting
StudySIBERITE-PEDS
SponsorHoffmann-La Roche
Study typeInterventional
Conditions
Moderate to severe crohn's disease
Requirements
To 17 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT07298421
