Cure8 trial brief
This trial explores whether oral ozanimod can induce and maintain remission in children and adolescents with moderate to severe ulcerative colitis who have not responded to standard therapies. Pediatric-specific evidence for IBD medications is limited, so results could expand treatment options.
Pediatric patients with moderate to severe ulcerative colitis, parents and caregivers, pediatric gastroenterologists, and IBD clinical researchers.
This is a randomized trial with two ozanimod dosing arms (high dose and low dose) aiming to evaluate the drug’s effectiveness and safety for inducing and maintaining clinical remission, with a primary endpoint measured at Week 52. The study plans to enroll about 120 pediatric participants and excludes patients with Crohn’s disease, positive C.
difficile testing, or certain immunodeficiencies, among other criteria. The record is a trial registration (Phase 2/3, interventional) and does not report results. If you are considering participation, discuss eligibility, potential risks, and unknown benefits with your child’s gastroenterologist and the study team.
This is a trial registry entry (Phase 2/3) and does not present study results. Ozanimod is an S1P receptor modulator; safety and effectiveness in children are under investigation. Enrollment, inclusion/exclusion details, and study procedures are available on the clinicaltrials.gov record; contact the listed sites for up-to-date information.
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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