What is filgotinib studying for ulcerative colitis in children and teenagers?

Filgotinib is being studied to evaluate its effects on ulcerative colitis in children and adolescents aged 8 to less than 18 years. Researchers want to learn about how well the medicine works, how safe and tolerable it is, and how the body processes it. The study is sponsored by Alfasigma S.p.A. and focuses on those with moderately to severely active ulcerative colitis.

Who may be eligible for this ulcerative colitis clinical trial?

Children and teenagers aged 8 to less than 18 years with a diagnosis of ulcerative colitis lasting at least 3 months may be eligible. Participants must weigh at least 15 kg and have certain disease activity scores. Those who have used Janus kinase inhibitors before or have certain infections or surgeries may be excluded. Please review eligibility criteria for more details.

Is there any cost to participate in this ulcerative colitis clinical trial?

Study-related care, including the study drug and all trial visits, is provided at no cost. However, personal travel expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any travel or accommodation costs.

Actively Recruiting

Phase 3

Age: 8Years - 18Years

All Genders

ID06865417

A Multicenter Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Filgotinib, With Single Arm Induction and Maintenance, in Pediatric Subjects 8 to 18 Years of Age With Moderately to Severely Active Ulcerative Colitis

Led by Alfasigma S.p.A. · Updated on 2026-02-06

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating filgotinib in children and adolescents aged 8 to less than 18 years with moderately to severely active ulcerative colitis UC. This study aims to assess the medicines efficacy, safety, tolerability, and how the body processes it. About 80 participants will be enrolled, including at least 8 children aged 8 to under 12 years. The study focuses on those who have had insufficient response or intolerance to other treatments like corticosteroids or biologics. Participants will take filgotinib tablets once daily in the morning, with or without food. Doses are designed to achieve similar blood levels as seen in adults treated with 200 mg daily. On-site dosing will occur at Weeks 4, 10, and 22, while other doses are taken at home. Those not showing remission or response by Week 10 will continue induction treatment until Week 22. If remission is not reached by Week 22, participants will stop the study treatment. During the study, researchers will monitor participants health, collecting data on remission rates and response at Week 10 and beyond. Safety and tolerability will be assessed through Week 58 and Week 62. Participants will have regular visits to take medicines, report symptoms, and undergo examinations. The total participation time can last over a year as the study tracks long-term effects and treatment outcomes.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 8Years - 18Years

All Genders

Eligibility Criteria

You may qualify if you...

Participant must weigh at least 15 kg
Aged 8 to less than 18 years
Have a documented diagnosis of ulcerative colitis lasting at least 3 months
Have a modified Mayo Clinic Score (mMCS) between 5 to 9
Have an endoscopic Mayo Clinic Score (MCS) of 2 or higher
Have rectal bleeding score of 1 or higher
Have stool frequency score of 1 or higher
Have had inadequate response, loss of response, intolerance, or contraindications to corticosteroids, immunosuppressants, or biologic therapy
Includes those dependent on corticosteroids who worsen when tapering off

You will not qualify if you...

Diagnosis of inflammatory bowel disease unclassified, indeterminate colitis, isolated proctitis, or toxic megacolon
Active infection at the time of screening
History of complicated herpes zoster infection involving multiple dermatomes, dissemination, eyes, or central nervous system
Currently on therapy for chronic infections like pneumocystis, cytomegalovirus, herpes simplex, herpes zoster, or atypical mycobacteria
History of colectomy or extensive small bowel resection
Psychological or cognitive difficulties interfering with participation
Previous exposure to Janus kinase inhibitors or similar medications (e.g., tofacitinib, baricitinib, upadacitinib)
Female participants who are pregnant, breastfeeding, or intending to become pregnant or breastfeed during the study

Research Team

Vincenzo Teneggi, MD

Alexandra Mangili, MD

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