A Multicenter Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Filgotinib in Children and Adolescents With Moderately to Severely Active Ulcerative Colitis

What this Trial Is About

Researchers are studying the effects of filgotinib in children and adolescents aged 8 to less than 18 years who have moderately to severely active ulcerative colitis UC. The study aims to evaluate how well filgotinib works, its safety, how well it is tolerated, and how the body processes the drug in this young population. About 80 participants will be enrolled, including at least 8 children aged 8 to less than 12 years. Participants will take filgotinib once daily in the morning, either with or without food, using age-appropriate tablets. Doses are designed to match the systemic exposure seen in adults treated with 200 mg daily. Participants will take the medication at home except for on-site dosing at Weeks 4, 10, and 22. Those not reaching remission or response by Week 10 will continue induction treatment until Week 22, after which lack of remission will lead to discontinuation. During the study, participants will be monitored regularly to assess the drugs effectiveness and safety. The primary measure is remission at Week 10, with further assessments continuing through Week 58 and Week 62 to evaluate longer-term safety and tolerability. The total study duration extends to the primary completion date in June 2028.

A Study Evaluating the Effects of Filgotinib in Children and Teenagers With Ulcerative Colitis