Cure8 trial brief
A new pediatric Phase 3 trial of filgotinib could broaden approved treatment choices for children and teens with moderate-to-severe ulcerative colitis, especially for those who have not responded to or cannot tolerate existing therapies.
Pediatric patients with moderate-to-severe ulcerative colitis, parents and caregivers of children with UC, pediatric gastroenterologists, and clinical researchers focused on IBD therapies.
This ClinicalTrials.gov record describes a randomized interventional Phase 3 study enrolling about 80 pediatric subjects to assess efficacy, safety, tolerability, and pharmacokinetics of filgotinib for ulcerative colitis.
Eligible participants have moderate-to-severe UC and prior inadequate response or intolerance to corticosteroids, immunosuppressants, or biologics; prior exposure to other JAK inhibitors is excluded. The record lists multiple European pediatric sites.
The study is recruiting and is sponsored by Alfasigma S.p.A.; the ClinicalTrials.gov entry provides full trial design details, inclusion/exclusion criteria, and site information.
This is a trial record (Phase 3, recruiting) describing planned research — it does not report study results. Filgotinib is in the JAK-inhibitor class; the entry excludes patients with prior exposure to JAK inhibitors. Consult clinical teams or the trial sponsor/registry for enrollment and up-to-date protocol details.
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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