Cure8 trial brief
Mirikizumab is being tested specifically in children with moderate-to-severe Crohn’s disease; successful results could expand treatment options for pediatric IBD. The study measures both symptom-based and endoscopic responses, which are important to assess disease control in children.
Parents and caregivers of pediatric Crohn’s patients; pediatric gastroenterologists; researchers focused on pediatric IBD and biologic therapies.
This is a Phase 3, interventional trial (NCT05509777) testing mirikizumab in pediatric participants aged 2–17 with moderately to severely active Crohn’s disease.
The study includes a 12-week induction period, a maintenance period through Week 52, and a safety follow-up; primary outcomes are clinical response by PCDAI at Week 12 and endoscopic response by SES-CD at Week 52.
The trial plans weight-based IV or subcutaneous dosing and enrolls participants with prior inadequate response or intolerance to at least one CD medication (including biologics or JAK inhibitors). Planned enrollment is about 90 participants across multiple U.S. pediatric centers.
This entry is a clinicaltrials.gov record (Phase 3, recruiting) and does not provide study results. Interested families should consult their care team about eligibility and whether participation is appropriate.
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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