Ulcerative ColitisPhase 3GalapeducaNCT06865417
A Study Evaluating the Effects of Filgotinib in Children and Teenagers With Ulcerative Colitis
A Phase 3 study testing Filgotinib in people with Ulcerative Colitis, run by Alfasigma S.p.A. at 46 sites in 13 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- Filgotinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 46 sitesin 13 countries
- Study dates
- 29 Sep 2025to Jun 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
46 sites in 13 countries. Contact the study team or a site near you to ask about taking part.
46 sites in 13 countries
Italy7 sites, 7 recruiting
- Recruiting
Azienda Ospedaliero-Universitaria Ss Antonio E Biagio E Cesare Arrigo
Alessandria, Italy, 15121
Enrico Felici, MD, 0131207212, enrico.felici@ospedale.al.it
- Recruiting
Azienda Ospedaliero Universitaria dell Marche I G M Lancisi G Salesi
Ancona, Italy, 60123
Simona Gatti, MD, 0715962114, s.gatti@staff.univpm.it
- Recruiting
ASST Fatebenefratelli Sacco
Milan, Italy, 20154
Lorenzo Norsa, MD, 352673103, lorenzo.norsa@asst-fbf-sacco.it
- Recruiting
Azienda Ospedaliera Universitaria Federico II Di Napoli
Naples, Italy, 80131
Annamaria Staiano, MD, 0817462679, staiano@unina.it
- Recruiting
Azienda Ospedaliero-Universitaria Policlinico Umberto I
Rome, Italy, 00161
Salvatore Oliva, MD, 3928607214, salvatore.oliva@uniroma1.it
- Recruiting
Ospedale Pediatrico Bambino Gesu
Rome, Italy, 00165
Daniela Knafelz, MD, 668592243, aniela.knafelz@opbg.net
- Recruiting
IRCCS Materno Infantile Burlo Garofolo
Trieste, Italy, 34137
Matteo Bramuzzo, MD, 0403785380, matteo.bramuzzo@burlo.trieste.it
France6 sites, 6 recruiting
- Recruiting
Hospital Femme Mere Enfant
Bron, France, 69500
Remi Duclaux-Loras, MD, +33427856030, remi.duclaux-loras@chu-lyon.fr
- Recruiting
Centre Hospitalier Universitaire De Dijon
Dijon, France, 21000
Raphaëlle Maudinas, MD, +33380295464, raphaelle.maudinas@chu-dijon.fr
- Recruiting
Hopital Saint Vincent de Paul - GHICL Lille
Lille, France, 59020
Ahlem Bouazza, MD, +33320877612, bouazza.ahlem@ghicl.net
- Recruiting
CHU de Montpellier
Montpellier, France, 34295
Grégoire Lavaud, MD, +330467339170, Gregoire.lavaud@chu-montpellier.fr
- Recruiting
Centre Hospitalier Universitaire De Rennes
Rennes, France, 35200
Laure Bridoux-Henno, MD, +33299267177, laure.bridoux-henno@chu-rennes.fr
- Recruiting
Centre Hospitalier Regional Universitaire De Tours
Tours, France, 37000
Stéphanie Willot, MD, +33247474755, s.willot@chu-tours.fr
United Kingdom5 sites, 5 recruiting
- Recruiting
Bristol Royal Infirmary
Bristol, BS2 8HW
Christine Spray, +441173420154, christine.spray@uhbw.nhs.uk
- Recruiting
Ninewells Hospital
Glasgow, G51 4TF
Richard Hansen, +441414516543, richard.hansen2@nhs.scot
- Recruiting
Alder Hey Children's Hospital
Liverpool
Fiona Cameron
- Recruiting
Chelsea and Westminster Hospital
London, SW10 9NH
Dhamyanthi Thangarajah, +442033156642, anthi.thangarajah@nhs.net
- Recruiting
Sheffield Children's Hospital
Sheffield, S10 2TH
Akshay Kapoor, +447765449469, akshay.kapoor1@nhs.net
Germany4 sites, 4 recruiting
- Recruiting
Universitaetsklinikum Aachen AöR
Aachen, Germany, 52074
Tobias Wenzl, MD, +492418088700, twenzl@ukaachen.de
- Recruiting
Universitaetsklinikum Leipzig AöR
Leipzig, Germany, 04103
Gunter Flemming, MD, +493419726822, gunter.flemming@medizin.uni-leipzig.de
- Recruiting
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
Mainz, Germany, 55131
Stephan Gehring, MD, +496131173560, stephan.gehring@uni-mainz.de
- Recruiting
Universitaetsklinikum Tuebingen AöR
Tübingen, Germany, 72076
Johannes Hilberath, MD, +49070712981328, johannes.hilberath@med.uni-tuebingen.de
Greece4 sites, 4 recruiting
- Not yet recruiting
Athens General Children's Hospital Panagioti And Aglaia Kyriakou
Athens, Greece, 11527
Ioanna Argyri, MD, 2132009469, ioarg@yahoo.gr
- Recruiting
University General Hospital Attikon
Athens, Greece, 12462
Smaragdi Fessatou, MD, 2105832228, sfessatou@gmail.com
- Recruiting
General Hospital Of Thessaloniki Papageorgiou
Efkarpia, Greece, 56429
Maria Fotoulaki, MD, 6944949964, mfotoul@otenet.gr
- Recruiting
Hippokration Hospital
Thessaloniki, Greece, 54642
Ioannis Xinias, MD, 2310992877, xinias@email.com
Poland4 sites, 4 recruiting
- Recruiting
In Vivo Sp. z o.o.
Bydgoszcz, Poland, 85-048
Piotr Korbal, MD, 723351052, kontakt@in-vivo.pl
- Recruiting
Instytut Centrum Zdrowia Matki Polki
Lodz, Poland, 93-338
Elżbieta Czkwianianc, MD, +48501750855, elzbieta.czkwianianc@iczmp.edu.pl
- Recruiting
Gabinet Lekarski Bartosz Korczowski
Rzeszów, Poland, 35-302
Bartosz Korczowski, MD, +48604481752, korczowski@op.pl
- Recruiting
Instytut Pomnik Centrum Zdrowia Dziecka
Warsaw, Poland, 04-730
Jarosław Kierkuś, MD, +48500111648, j.kierkus@wip.waw.pl
Belgium3 sites, 3 recruiting
- Recruiting
Association Hospitaliere De Bruxelles Hopital Universitaire Des Enfants Reine Fabiola
Brussels, Brussels Capital, 1020
Patrick Bontems, MD, +3224773216, patrick.bontems@huderf.be
- Recruiting
Centre Hospitalier Regional De La Citadelle
Liège, Liege, 4000
Marie Leonard, MD, +3243215259, marie.leonard@citadelle.be
- Recruiting
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur
Namur, Namur, 5000
Sabine Jespers, MD, 003281720745, sabine.jespers@chuuclnamur.uclouvain.be
Croatia3 sites, 3 recruiting
- Recruiting
Klinicki Bolnicki Centar Osijek
Osijek, Croatia, 31000
Vlatka Konjik, MD, +38531511511, vlatkajurkovic@yahoo.com
- Recruiting
Children's Hospital Zagreb
Zagreb, Croatia, 10000
Iva Hojsak, MD, +385914600342, ivahojsak@gmail.com
- Recruiting
University Hospital Centre Zagreb
Zagreb, Croatia, 10000
Irena Senečić Čala, MD, +385914922687, isenecic@yahoo.com
Portugal3 sites, 3 recruiting
- Recruiting
CCAB Centro Clinico Academico Braga Associacao
Braga, Portugal, 4710-243
Henedina Antunes, MD, 253604870, henedina.antunes@hb.min-saude.pt
- Recruiting
Hospital Pediátrico de Coimbra
Coimbra, Portugal, 3000-602
Juliana Roda, MD, 239488700, juroda@ulscoimbra.min-saude.pt
- Recruiting
Unidade Local De Saude Do Alto Minho E.P.E.
Viana do Castelo, Portugal, 4904-858
Isabel Martinho, MD, 258802444, isabel.martinho@ulsam.min-saude.pt
Norway2 sites, 2 recruiting
- Recruiting
Oslo University Hospital HF
Oslo, Norway, 0372
Gori Perminow, MD, +4791721497, goeper@ous-hf.no
- Recruiting
Sykehuset I Vestfold HF
Tønsberg, Norway, 3116
Johannes Rolin, MD, +4795993543, rolijo@siv.no
Romania2 sites, 2 recruiting
- Recruiting
Dr. Victor Gomoiu Clinical Children Hospital
Bucharest, Romania, 022102
Iulia Florentina Tincu, MD, +40725535100, if_boian@yahoo.com
- Recruiting
Spitalul Clinic De Urgenta Pentru Copii Louis Turcanu Timisoara
Timișoara, Romania, 300011
Oana Belei, MD, 0256203356, oana22_99@yahoo.com
Spain2 sites, 2 recruiting
- Recruiting
Hospital Germans Trias I Pujol
Badalona, Spain, 08916
Maria Victoria Bovo, MD, +34934978928, mariavictoriabovo@gmail.com
- Recruiting
Hospital Universitario Reina Sofia
Córdoba, Spain
Rafael González de Caldas, MD, 957010350, rgonzalezdecaldasmarchal@gmail.com
Ireland1 site, 1 recruiting
- Not yet recruiting
Children's Health Ireland
Dublin, Ireland, D12 PN40
Seamus Hussey, MD, +35314096100, seamus.hussey@olchc.ie
About this study
Official 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
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.
Read more
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.
- Conditions
- Ulcerative Colitis
- Being tested
- Filgotinib
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FilgotinibDrug
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).
| Study group | Role | What they receive |
|---|---|---|
| Filgotinib | Experimental | Filgotinib Receives: Drug: Filgotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of filgotinib in induction of remission and maintenance of effect in pediatric subjects with ulcerative colitis (UC)
Proportion of subjects achieving clinical remission based on modified Mayo Clinical Score (mMCS)
Measured: Week 10
subjects with ulcerative colitis (UC)
Proportion of subjects achieving clinical remission based on mMCS
Measured: Week 58
Secondary outcomes (3)
Safety and tolerability of filgotinib in pediatric subjects with UC
Incidence of treatment-emergent adverse events (TEAEs), adverse events of interest, and laboratory abnormalities through follow-up
Measured: Week 62
Safety and tolerability of filgotinib in pediatric subjects with UC
Change from baseline in body mass index (BMI)
Measured: Week 58
Safety and tolerability of filgotinib in pediatric subjects with U
Change from baseline in height velocity
Measured: Week 58
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2025
- Study start29 Sep 2025
- Primary completionJun 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alfasigma S.p.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06865417
- Sponsor's protocol ID
- GLPG0634-CL-331
- Acronym
- Galapeduca
- Status last verified
- Oct 2026
- First submitted
- 4 Mar 2025
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06865417
- Acronym / sponsor ID
- Galapeduca / GLPG0634-CL-331
- Conditions
- Ulcerative Colitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Alfasigma S.p.A.Industry (pharma, biotech, devices)
- Study start
- 29 Sep 2025 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 7 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Filgotinib | Experimental | Drug: FilgotinibFilgotinib |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Subject must have a minimum body weight (BW) of 15 kg.
- Subject:
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FilgotinibIP 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). | Drug | Filgotinib |
Primary outcome
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)
subjects with ulcerative colitis (UC)
Time frame: Week 58
Proportion of subjects achieving clinical remission based on mMCS
3 secondary outcomes
Safety and tolerability of filgotinib in pediatric subjects with UC
Time frame: Week 62
Safety and tolerability of filgotinib in pediatric subjects with UC
Time frame: Week 58
Safety and tolerability of filgotinib in pediatric subjects with U
Time frame: Week 58
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
Related trials for Ulcerative Colitis
Not yet recruitingPhase 1
An Open-label, DDI Study to Investigate the Effects of Duvakitug on the PK of Selected Cytochrome P450 Substrates
Ulcerative Colitis, Crohn's Disease
RecruitingObservational study
Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease
Inflammatory Bowel Disease, Crohn's Disease
RecruitingObservational study
Ibd CAncer and seRious Infections in France (I-CARE 2)
IBD, Ulcerative Colitis
RecruitingObservational study
Characterization of Colorectal Dysplasic Lesions and Stratification of Their Evolving Risk in Inflammatory Bowel Disease Patients: a Prospective, Observational and Multicenter Study
Crohn Disease (CD), Colitis Ulcerative
Enrolling by invitationPhase 4
MOdel-Informed Precision Dosing of Ustekinumab and VEdolizumab in Inflammatory Bowel Disease
Inflammatory Bowel Diseases, Crohn Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
46 sites in 13 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Filgotinib in people with Ulcerative Colitis, run by Alfasigma S.p.A. at 46 sites in 13 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 46 sites in Italy, France, United Kingdom, Germany, Greece and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vincenzo Teneggi, MD (00800 7878 1345, vincenzo.teneggi@external.alfasigma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of filgotinib in induction of remission and maintenance of effect in pediatric subjects with ulcerative colitis (UC) (time frame: Week 10). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.