Cure8 trial brief
This trial could expand approved treatment options for children with moderate to severe UC by testing the safety, pharmacokinetics, and maintenance dosing of risankizumab in pediatric age groups.
Pediatric patients with moderate to severe ulcerative colitis, parents and caregivers, pediatric gastroenterologists, and researchers involved in pediatric IBD drug development.
This is a multi-cohort Phase 3 interventional trial (recruiting) designed to enroll about 120 pediatric participants across three age cohorts. The study includes an open-label 12-week IV induction (SS1), a 52-week double-blind randomized maintenance period with two dose options (SS2), and a long-term open-label extension (SS3) with subcutaneous dosing.
Primary measurements include pharmacokinetic endpoints (Cmax, Tmax, AUC) and safety and disease activity assessments. The trial is sponsored by AbbVie and is explicitly testing risankizumab in children; risankizumab is already approved for adult UC in some countries but is being developed here for pediatric use.
Participation involves regular hospital/clinic visits, blood tests, colonoscopic confirmation for eligibility, and a potentially higher treatment burden than routine care.
This is a trial record (Phase 3, recruiting) describing planned interventions and outcomes; it does not report results. The primary endpoints include pharmacokinetic measures at specific time points. Eligibility requires documented moderate-to-severe UC and prior inadequate response or intolerance to other therapies.
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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