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

August 11, 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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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
        • Not yet recruiting
        • Centre Hospitalier Regional De La Citadelle
        • Contact:
    • Namur
      • Namur, Namur, Belgium, 5000
  • Croatia
    • Croatia
      • Osijek, Croatia, Croatia, 31000
        • 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 Gesu
        • 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:
      • 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
        • Recruiting
        • Hospital Germans Trias i Pujol
        • Contact:
      • Córdoba, Spain, Spain
  • United Kingdom
      • Bristol, United Kingdom, BS2 8HW
      • Glasgow, United Kingdom, G51 4TF
      • Liverpool, United Kingdom
        • Recruiting
        • Alder Hey Children's Hospital
        • Contact:
          • Fiona Cameron
      • 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:
          • David Campbell
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 29, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 4, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 4, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 7, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 12, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 11, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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