Cure8 trial brief
A Phase 3 study is testing whether oral tofacitinib can induce and maintain remission in children with moderate-to-severe ulcerative colitis — a key step before pediatric regulatory approvals and wider clinical use.
Pediatric patients with moderate-to-severe UC, parents/caregivers, pediatric gastroenterologists, and researchers in pediatric IBD drug development.
This is an open-label Phase 3 study (A3921210) sponsored by Pfizer for pediatric UC. All enrolled participants receive an initial weight-based dose equivalent to adult 5 mg twice daily, with the option for temporary escalation to a 10 mg twice-daily adult-equivalent dose if prespecified criteria are met, followed by return to the lower dose.
The study includes induction (8 or 16 weeks), a 44-week maintenance phase measured by central-read Mayo score, and a 24-month extension; total maximum participation is up to ~180 weeks. The trial enrolls children aged 2–17 with moderately to severely active UC (Mayo score and PUCAI thresholds specified).
Eligibility differs by region: in the US/EU participants must have prior inadequate response or intolerance to TNF inhibitors; outside those regions broader prior-therapy requirements (steroids, azathioprine/6-MP, or biologics) apply.
Standard baseline testing such as colonoscopy with central read and biopsy is incorporated for eligibility and outcome assessment.
This ClinicalTrials.gov record describes the study design and eligibility but does not present results. The study is open-label with weight-based dosing to match adult exposure; regional differences in prior-therapy requirements are specified. Safety exclusions include factors increasing venous thromboembolism risk.
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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