Cure8 trial brief
A Phase 3 study is testing whether upadacitinib is safe and effective for children with moderate-to-severe Crohn's disease who have not responded to or cannot take other therapies. Positive results could expand treatment options for pediatric IBD.
Pediatric Crohn's patients and their caregivers, pediatric gastroenterology clinicians, and IBD researchers tracking drug development.
This study enrolls roughly 110 pediatric participants and includes a 12-week open-label induction, a 52-week randomized double-blind maintenance comparing two doses, and a 156-week open-label extension.
Primary outcomes include PCDAI-defined clinical response at Week 12 and clinical remission and endoscopic response at Week 64; safety (adverse events) is tracked through Week 156. Dosing is weight-based with oral tablets or solution.
This is a clinicaltrials.gov registry entry (Phase 3, active not recruiting) describing study design and planned outcomes; it does not present study results. Enrollment criteria require prior inadequate response or intolerance to corticosteroids, immunomodulators, and/or biologics.
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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