Cure8 trial brief
Long-term safety information matters for people with ulcerative colitis considering or already taking filgotinib, because LTE studies track adverse events and lab changes over years. Findings from such a study can influence treatment decisions and monitoring plans.
Adults with ulcerative colitis who have received or are considering filgotinib, gastroenterologists and IBD clinicians, clinical researchers, and patients interested in long-term safety of JAK inhibitors.
This is a ClinicalTrials.gov record for a Phase 3 long-term extension (LTE) study of filgotinib in adults with ulcerative colitis who completed or met discontinuation criteria in prior filgotinib UC trials.
The study is interventional, completed, and planned to follow participants up to 336 weeks to evaluate long-term safety, with filgotinib dosed at 100 mg or 200 mg (blinded and open-label arms) and a placebo arm.
The trial enrolls adults previously treated with filgotinib in sponsor parent studies and focuses on safety outcomes (adverse events and laboratory abnormalities) over an extended period.
Eligibility requires prior participation in Gilead/Galapagos-sponsored filgotinib UC trials and standard contraception and pregnancy-testing requirements for participants of childbearing potential. Locations listed include multiple US clinical sites.
The registry record does not present results; it describes design, interventions, planned follow-up, and safety-focused primary outcomes.
This registry entry describes the trial design and planned outcomes but does not report study results. Filgotinib is a JAK inhibitor; any safety signals or efficacy implications would come from trial results or peer-reviewed publications, not this record alone.
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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