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Filgotinib for children and teenagers with ulcerative colitis

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

Phase 3 Interventional Alfasigma S.p.A. · NCT06865417

This will test whether filgotinib helps children and teenagers (8 to under 18 years) with moderate-to-severe ulcerative colitis control their symptoms and reduce disease activity.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment80 (estimated)
Ages8 Years to 18 Years
SexAll
SponsorAlfasigma S.p.A. Industry-sponsored
Drugs / interventionstofacitinib, baricitinib, upadacitinib, filgotinib
Locations51 sites (Brussels, Brussels Capital and 50 other locations)
Trial IDNCT06865417 on ClinicalTrials.gov

What this trial studies

This Phase 3 interventional trial gives filgotinib to about 80 patients aged 8 to under 18 with moderately to severely active ulcerative colitis, targeting the same blood exposure seen in adults. Eligible participants take the study drug at home daily, with supervised on-site dosing at Weeks 4, 10, and 22, and nonresponders at Week 10 continue induction through Week 22. The trial collects efficacy, safety, tolerability, and pharmacokinetic data and requires endoscopic and clinical scoring to define response and remission. Patients who fail to achieve clinical remission by prespecified timepoints are discontinued per protocol.

Who should consider this trial

Good fit: Children and teenagers aged 8 to under 18 years, weighing at least 15 kg, with moderately to severely active ulcerative colitis and prior inadequate response, loss of response, intolerance, or contraindication to corticosteroids, immunosuppressants, or biologics are the intended candidates.

Not a fit: Patients with isolated proctitis, inflammatory bowel disease unclassified, toxic megacolon, active infection, or a history of complicated herpes zoster are excluded and unlikely to benefit from this trial.

Why it matters

Potential benefit: If successful, filgotinib could provide an effective oral treatment option that lowers disease activity and may reduce reliance on corticosteroids in pediatric UC.

How similar studies have performed: Adult trials of filgotinib and other JAK1 inhibitors have shown efficacy in ulcerative colitis, but pediatric data are limited, so this approach is being tested specifically in children and adolescents.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Subject must have a minimum body weight (BW) of 15 kg.
* Subject:

  * has documented diagnosis of UC with a minimum duration of 3 months,
  * has mMCS of 5 to 9, and an MCS endoscopic score \>=2, rectal bleeding \>=1, and stool frequency \>=1,
  * has had an inadequate response, loss of response, intolerance, or has medical contraindications to corticosteroids, immunosuppressants, and/or biologic therapy. This includes subjects who depend on corticosteroids to control their symptoms and who experience worsening of their disease when attempting to wean off corticosteroids.

Exclusion Criteria:

* Subject has a diagnosis of inflammatory bowel disease -unclassified or indeterminate colitis, isolated proctitis, or toxic megacolon.
* Subject has an active infection.
* Subject with a history of complicated herpes zoster infection (with multi-dermatomal, disseminated, ophthalmic, or central nervous system involvement).
* Currently on any therapy for chronic infection (such as pneumocystis, cytomegalovirus, herpes simplex, herpes zoster, or atypical mycobacteria).
* Subject has a history of colectomy or extensive small bowel resection.
* Subject with psychological or cognitive difficulties that might interfere with study participation.
* Subject has any previous exposure to a Janus kinase inhibitor or medication with a similar mode of action (e.g. tofacitinib, baricitinib, upadacitinib).
* Female subject is pregnant or breast feeding or intending to become pregnant or breastfeed during the study.

Where this trial is running

Brussels, Brussels Capital and 50 other locations

+1 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Ulcerative Colitis
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.