Filgotinib for children and teenagers with ulcerative colitis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Association Hospitaliere De Bruxelles Hopital Universitaire Des Enfants Reine Fabiola
  Brussels, Brussels Capital, Belgium Recruiting
• Centre Hospitalier Regional De La Citadelle
  Liège, Liege, Belgium Recruiting
• Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur
  Namur, Namur, Belgium Recruiting
• Klinicki Bolnicki Centar Osijek
  Osijek, Croatia, Croatia Recruiting
• Children's Hospital Zagreb
  Zagreb, Croatia, Croatia Recruiting
• University Hospital Centre Zagreb
  Zagreb, Croatia, Croatia Recruiting

Study contacts

• Study coordinator: Vincenzo Teneggi, MD
• Email: vincenzo.teneggi@external.alfasigma.com
• Phone: 00800 7878 1345

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.