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

February 4, 2026 updated by: Alfasigma S.p.A.

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Belgium
    • Brussels Capital
      • Brussels, Brussels Capital, Belgium, 1020
        • Not yet recruiting
        • Association Hospitaliere De Bruxelles Hopital Universitaire Des Enfants Reine Fabiola
        • Contact:
    • Liege
      • Liège, Liege, Belgium, 4000
        • Recruiting
        • Centre Hospitalier Régional de la Citadelle
        • Contact:
    • Namur
      • Namur, Namur, Belgium, 5000
        • Not yet recruiting
        • Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur
        • Contact:
  • Croatia
    • Croatia
      • Osijek, Croatia, Croatia, 31000
        • Not yet recruiting
        • Klinicki Bolnicki Centar Osijek
        • Contact:
      • Zagreb, Croatia, Croatia, 10000
        • Recruiting
        • Children's Hospital Zagreb
        • Contact:
      • Zagreb, Croatia, Croatia, 10000
        • Recruiting
        • University Hospital Centre Zagreb
        • Contact:
  • France
    • France
      • Bron, France, France, 69500
      • Dijon, France, France, 21000
      • Lille, France, France, 59020
        • Recruiting
        • Hopital Saint Vincent de Paul - GHICL Lille
        • Contact:
      • Montpellier, France, France, 34295
      • Rennes, France, France, 35200
      • Tours, France, France, 37000
        • Recruiting
        • Centre Hospitalier Régional Universitaire de Tours
        • Contact:
  • Germany
    • Germany
      • Aachen, Germany, Germany, 52074
        • Recruiting
        • Universitaetsklinikum Aachen AöR
        • Contact:
      • Leipzig, Germany, Germany, 04103
      • Mainz, Germany, Germany, 55131
        • Recruiting
        • Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
        • Contact:
      • Tübingen, Germany, Germany, 72076
  • Greece
    • Greece
      • Athens, Greece, Greece, 11527
        • Not yet recruiting
        • Athens General Children's Hospital Panagioti And Aglaia Kyriakou
        • Contact:
      • Athens, Greece, Greece, 12462
        • Recruiting
        • University General Hospital Attikon
        • Contact:
      • Efkarpia, Greece, Greece, 56429
        • Recruiting
        • General Hospital Of Thessaloniki Papageorgiou
        • Contact:
      • Thessaloniki, Greece, Greece, 54642
        • Recruiting
        • Hippokration Hospital
        • Contact:
  • Ireland
    • Ireland
      • Dublin, Ireland, Ireland, D12 PN40
        • Not yet recruiting
        • Children's Health Ireland
        • Contact:
  • Italy
    • Italy
      • Alessandria, Italy, Italy, 15121
        • Recruiting
        • Azienda Ospedaliero-Universitaria SS Antonio e Biagio e Cesare Arrigo
        • Contact:
      • Ancona, Italy, Italy, 60123
        • Recruiting
        • Azienda Ospedaliero Universitaria dell Marche I G M Lancisi G Salesi
        • Contact:
      • Milan, Italy, Italy, 20154
      • Naples, Italy, Italy, 80131
        • Recruiting
        • Azienda Ospedaliera Universitaria Federico II di Napoli
        • Contact:
      • Rome, Italy, Italy, 00165
        • Recruiting
        • Ospedale Pediatrico Bambino Gesù
        • Contact:
      • Rome, Italy, Italy, 00161
        • Recruiting
        • Azienda Ospedaliero-Universitaria Policlinico Umberto I
        • Contact:
      • Trieste, Italy, Italy, 34137
  • Norway
    • Norway
      • Oslo, Norway, Norway, 0372
        • Recruiting
        • Oslo University Hospital HF
        • Contact:
      • Tønsberg, Norway, Norway, 3116
        • Recruiting
        • Sykehuset i Vestfold HF
        • Contact:
          • Johannes Rolin, MD
          • Phone Number: +4795993543
          • Email: rolijo@siv.no
  • Poland
    • Poland
      • Bydgoszcz, Poland, Poland, 85-048
        • Recruiting
        • IN VIVO Sp. z o.o.
        • Contact:
      • Gdansk, Poland, Poland, 80-803
        • Not yet recruiting
        • COPERNICUS Podmiot Leczniczy Sp. z o.o.
        • Contact:
      • Krakow, Poland, Poland, 30-663
        • Not yet recruiting
        • Uniwersytecki Szpital Dzieciecy w Krakowie
        • Contact:
      • Lodz, Poland, Poland, 93-338
      • Rzeszów, Poland, Poland, 35-302
        • Recruiting
        • Gabinet Lekarski Bartosz Korczowski
        • Contact:
      • Warsaw, Poland, Poland, 04-730
        • Recruiting
        • Instytut Pomnik Centrum Zdrowia Dziecka
        • Contact:
  • Portugal
    • Portugal
      • Braga, Portugal, Portugal, 4710-243
      • Coimbra, Portugal, Portugal, 3000-602
      • Viana do Castelo, Portugal, Portugal, 4904-858
  • Romania
    • Romania
      • Bucharest, Romania, Romania, 022102
        • Recruiting
        • Dr. Victor Gomoiu Clinical Children Hospital
        • Contact:
      • Timișoara, Romania, Romania, 300011
        • Recruiting
        • Spitalul Clinic de Urgenta pentru Copii Louis Turcanu Timisoara
        • Contact:
  • Spain
    • Spain
      • Badalona, Spain, Spain, 08916
        • Not yet recruiting
        • Hospital Germans Trias I Pujol
        • Contact:
      • Córdoba, Spain, Spain
  • United Kingdom
      • Bristol, United Kingdom, BS2 8HW
      • Cardiff, United Kingdom, CF14 4XW
        • Not yet recruiting
        • Noah's Ark Children's Hospital
        • Contact:
      • Glasgow, United Kingdom, G51 4TF
        • Not yet recruiting
        • Ninewells Hospital
        • Contact:
      • Liverpool, United Kingdom
      • London, United Kingdom, SW10 9NH
        • Not yet recruiting
        • Chelsea and Westminster Hospital
        • Contact:
      • Newcastle, United Kingdom, NE1 4LP
        • Not yet recruiting
        • The Newcastle upon Tyne Hospital FT
        • Contact:
      • Oxford, United Kingdom, OX3 9DU
        • Not yet recruiting
        • John Radcliffe Hospital
        • Contact:
      • Sheffield, United Kingdom, S10 2TH
        • Recruiting
        • Sheffield Children's Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Filgotinib
Drug: Filgotinib
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Week 10
subjects with ulcerative colitis (UC)
Time Frame: Week 58
Proportion of subjects achieving clinical remission based on mMCS
Week 58

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Week 62
Safety and tolerability of filgotinib in pediatric subjects with UC
Time Frame: Week 58
Change from baseline in body mass index (BMI)
Week 58
Safety and tolerability of filgotinib in pediatric subjects with U
Time Frame: Week 58
Change from baseline in height velocity
Week 58

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alfasigma S.p.A.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 29, 2025

Primary Completion (Estimated)

June 1, 2028

Study Completion (Estimated)

June 1, 2028

Study Registration Dates

First Submitted

March 4, 2025

First Submitted That Met QC Criteria

March 4, 2025

First Posted (Actual)

March 7, 2025

Study Record Updates

Last Update Posted (Actual)

February 6, 2026

Last Update Submitted That Met QC Criteria

February 4, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GLPG0634-CL-331

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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