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NCT Number: NCT06865417

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

The aim of this study is to evaluate the efficacy, safety, tolerability, and pharmacokinetics (PK) of filgotinib as a treatment for UC in children and adolescents aged from 8 to less than 18 years.

Approximately 80 subjects from 8 to <18 years of age with moderately to severely active UC, including a minimum of 8 subjects from 8 to <12 years of age, will be enrolled in this study.

During the study, eligible subjects will take the investigational product (IP) on-site at Week 4, Week 10, and Week 22 (in the morning; with or without food). On all other days, subjects will take IP at home (in the morning; with or without food).

Subjects who do not achieve mMCS remission and/or MCS response at Week 10 will continue with induction treatment until Week 22. Subjects who do not achieve PUCAI remission at Week 22 will be permanently discontinued from the study.

Subjects will all receive a filgotinib dose targeting the same systemic exposure as that observed in adults with UC treated with 200 mg q.d.

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Key information

Conditions

Ulcerative Colitis Colitis Colitis, Ulcerative Colonic Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

8 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Association Hospitaliere De Bruxelles Hopital Universitaire Des Enfants Reine Fabiola, Brussels, Brussels Capital, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Filgotinib

Drug

IP will be provided as commercially developed film-coated tablets (100 and 200 mg strength) or reduced-strength (65 mg) age-appropriate film-coated tablets for use in pediatric subjects aged at least 8 years and needs to be taken orally q.d. at approximately the same time every morning (with or without food).

Primary outcomes

  1. Efficacy of filgotinib in induction of remission and maintenance of effect in pediatric subjects with ulcerative colitis (UC)

    Time frame: Week 10

    Proportion of subjects achieving clinical remission based on modified Mayo Clinical Score (mMCS)

  2. subjects with ulcerative colitis (UC)

    Time frame: Week 58

    Proportion of subjects achieving clinical remission based on mMCS

Secondary outcomes

  1. Safety and tolerability of filgotinib in pediatric subjects with UC

    Time frame: Week 62

    Incidence of treatment-emergent adverse events (TEAEs), adverse events of interest, and laboratory abnormalities through follow-up

  2. Safety and tolerability of filgotinib in pediatric subjects with UC

    Time frame: Week 58

    Change from baseline in body mass index (BMI)

  3. Safety and tolerability of filgotinib in pediatric subjects with U

    Time frame: Week 58

    Change from baseline in height velocity

Study contacts

Contact information is provided by the study sponsor or research team.

Alexandra Mangili, MD

CONTACT

[email protected]

+041 795865622

Vincenzo Teneggi, MD

CONTACT

[email protected]

00800 7878 1345

Sponsors and collaborators

Lead sponsor

Alfasigma S.p.A.

Industry

Registry information

Official study title

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

Acronym: Galapeduca

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Mar 7, 2025
Registry last updated
Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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