A Study Evaluating the Effects of Filgotinib in Children and Teenagers With Ulcerative Colitis
NCT ID: NCT06865417
Last Updated: 2025-12-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
80 participants
INTERVENTIONAL
2025-09-29
2028-06-30
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Filgotinib
Filgotinib
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).
Interventions
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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).
Eligibility Criteria
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Inclusion Criteria
* 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 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.
8 Years
18 Years
ALL
No
Sponsors
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Alfasigma S.p.A.
INDUSTRY
Responsible Party
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Locations
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Association Hospitaliere De Bruxelles Hopital Universitaire Des Enfants Reine Fabiola
Brussels, Brussels Capital, Belgium
Centre Hospitalier Regional De La Citadelle
Liège, Liege, Belgium
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur
Namur, Namur, Belgium
Klinicki Bolnicki Centar Osijek
Osijek, Croatia, Croatia
Children's Hospital Zagreb
Zagreb, Croatia, Croatia
University Hospital Centre Zagreb
Zagreb, Croatia, Croatia
Hospital Femme Mere Enfant
Bron, France, France
Centre Hospitalier Universitaire De Dijon
Dijon, France, France
Hopital Saint Vincent de Paul - GHICL Lille
Lille, France, France
CHU de Montpellier
Montpellier, France, France
Centre Hospitalier Universitaire De Rennes
Rennes, France, France
Centre Hospitalier Regional Universitaire De Tours
Tours, France, France
Universitaetsklinikum Aachen AöR
Aachen, Germany, Germany
Universitaetsklinikum Leipzig AöR
Leipzig, Germany, Germany
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
Mainz, Germany, Germany
Universitaetsklinikum Tuebingen AöR
Tübingen, Germany, Germany
Athens General Children's Hospital Panagioti And Aglaia Kyriakou
Athens, Greece, Greece
University General Hospital Attikon
Athens, Greece, Greece
General Hospital Of Thessaloniki Papageorgiou
Efkarpia, Greece, Greece
Hippokration Hospital
Thessaloniki, Greece, Greece
Children's Health Ireland
Dublin, Ireland, Ireland
Azienda Ospedaliero-Universitaria Ss Antonio E Biagio E Cesare Arrigo
Alessandria, Italy, Italy
Azienda Ospedaliero Universitaria dell Marche I G M Lancisi G Salesi
Ancona, Italy, Italy
ASST Fatebenefratelli Sacco
Milan, Italy, Italy
Azienda Ospedaliera Universitaria Federico II Di Napoli
Naples, Italy, Italy
Azienda Ospedaliero-Universitaria Policlinico Umberto I
Rome, Italy, Italy
Ospedale Pediatrico Bambino Gesu
Rome, Italy, Italy
IRCCS Materno Infantile Burlo Garofolo
Trieste, Italy, Italy
Oslo University Hospital HF
Oslo, Norway, Norway
Sykehuset I Vestfold HF
Tønsberg, Norway, Norway
In Vivo Sp. z o.o.
Bydgoszcz, Poland, Poland
Copernicus Podmiot Leczniczy Sp. z o.o.
Gdansk, Poland, Poland
Uniwersytecki Szpital Dzieciecy W Krakowie
Krakow, Poland, Poland
Instytut Centrum Zdrowia Matki Polki
Lodz, Poland, Poland
Gabinet Lekarski Bartosz Korczowski
Rzeszów, Poland, Poland
Instytut Pomnik Centrum Zdrowia Dziecka
Warsaw, Poland, Poland
CCAB Centro Clinico Academico Braga Associacao
Braga, Portugal, Portugal
Hospital Pediátrico de Coimbra
Coimbra, Portugal, Portugal
Unidade Local De Saude Do Alto Minho E.P.E.
Viana do Castelo, Portugal, Portugal
Dr. Victor Gomoiu Clinical Children Hospital
Bucharest, Romania, Romania
Spitalul Clinic De Urgenta Pentru Copii Louis Turcanu Timisoara
Timișoara, Romania, Romania
Hospital Germans Trias I Pujol
Badalona, Spain, Spain
Hospital Universitario Reina Sofia
Córdoba, Spain, Spain
Bristol Royal Infirmary
Bristol, , United Kingdom
Noah's Ark Children's Hospital
Cardiff, , United Kingdom
Ninewells Hospital
Glasgow, , United Kingdom
Alder Hey Children's Hospital
Liverpool, , United Kingdom
Chelsea and Westminster Hospital
London, , United Kingdom
The Newcastle upon Tyne Hospital FT
Newcastle, , United Kingdom
John Radcliffe Hospital
Oxford, , United Kingdom
Sheffield Children's Hospital
Sheffield, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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GLPG0634-CL-331
Identifier Type: -
Identifier Source: org_study_id
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