Cure8 trial brief
The trial tests ustekinumab dosing, safety, and pharmacokinetics specifically in children with moderate–severe Crohn’s — information that can affect pediatric treatment options and dosing guidance once results are available.
Pediatric Crohn’s patients and caregivers; pediatric gastroenterologists; researchers studying biologics in children.
This is the ClinicalTrials.gov record for a completed Phase 3 interventional study testing ustekinumab in pediatric participants with moderately to severely active Crohn’s disease.
The trial evaluated IV induction followed by subcutaneous maintenance (every 8‑ or 12‑weeks dosing schedules), and measured induction and maintenance clinical remission (including PCDAI and endoscopic/biomarker criteria), safety, and pharmacokinetics.
The entry lists key eligibility criteria (moderately–severe pediatric Crohn’s with endoscopic or biomarker evidence of active disease), planned enrollment (~101), exclusion criteria (e.g., symptomatic strictures, certain infections, prior malignancy), and multiple US pediatric clinical sites.
The record is a trial registry entry describing design, not trial results.
This is a registry (trial-record) entry describing study design and endpoints; it does not contain efficacy or safety results. Consult published study reports or regulatory summaries for outcome data.
Review the original publication for the complete reporting, methods, and context.
This Cure8 brief is based on source text from the linked article. Cure8 is informational only and is not a substitute for professional medical advice, diagnosis, or treatment.
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