RecruitingRecruiting
A Study Evaluating the Effects of Filgotinib in Children and Teenagers With Ulcerative Colitis
NCT06865417 · Alfasigma S.p.A.
In plain English
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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
About this study
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.
Eligibility criteria
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 design
Enrollment target: 80 participants
Allocation: na
Masking: none
Age groups: child, adult
Timeline
Starts: 2025-09-29
Estimated completion: 2028-06
Last updated: 2026-06-12
Interventions
Drug: Filgotinib
Primary outcomes
- • Efficacy of filgotinib in induction of remission and maintenance of effect in pediatric subjects with ulcerative colitis (UC) (Week 10)
- • subjects with ulcerative colitis (UC) (Week 58)
Sponsor
Alfasigma S.p.A. · industry
Contacts & investigators
ContactVincenzo Teneggi, MD · contact · vincenzo.teneggi@external.alfasigma.com · 00800 7878 1345
ContactAlexandra Mangili, MD · contact · alexandra.mangili@alfasigma.com · +041 795865622
All locations (47)
Association Hospitaliere De Bruxelles Hopital Universitaire Des Enfants Reine FabiolaNot Yet Recruiting
Brussels, Brussels Capital, Belgium
Centre Hospitalier Regional De La CitadelleNot Yet Recruiting
Liège, Liege, Belgium
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-NamurRecruiting
Namur, Namur, Belgium
Klinicki Bolnicki Centar OsijekRecruiting
Osijek, Croatia, Croatia
Children's Hospital ZagrebRecruiting
Zagreb, Croatia, Croatia
University Hospital Centre ZagrebRecruiting
Zagreb, Croatia, Croatia
Hospital Femme Mere EnfantRecruiting
Bron, France, France
Centre Hospitalier Universitaire De DijonRecruiting
Dijon, France, France
Hopital Saint Vincent de Paul - GHICL LilleRecruiting
Lille, France, France
CHU de MontpellierRecruiting
Montpellier, France, France
Centre Hospitalier Universitaire De RennesRecruiting
Rennes, France, France
Centre Hospitalier Regional Universitaire De ToursRecruiting
Tours, France, France
Universitaetsklinikum Aachen AöRRecruiting
Aachen, Germany, Germany
Universitaetsklinikum Leipzig AöRRecruiting
Leipzig, Germany, Germany
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöRRecruiting
Mainz, Germany, Germany
Universitaetsklinikum Tuebingen AöRRecruiting
Tübingen, Germany, Germany
Athens General Children's Hospital Panagioti And Aglaia KyriakouNot Yet Recruiting
Athens, Greece, Greece
University General Hospital AttikonRecruiting
Athens, Greece, Greece
General Hospital Of Thessaloniki PapageorgiouRecruiting
Efkarpia, Greece, Greece
Hippokration HospitalRecruiting
Thessaloniki, Greece, Greece
Children's Health IrelandNot Yet Recruiting
Dublin, Ireland, Ireland
Azienda Ospedaliero-Universitaria Ss Antonio E Biagio E Cesare ArrigoRecruiting
Alessandria, Italy, Italy
Azienda Ospedaliero Universitaria dell Marche I G M Lancisi G SalesiRecruiting
Ancona, Italy, Italy
ASST Fatebenefratelli SaccoRecruiting
Milan, Italy, Italy
Azienda Ospedaliera Universitaria Federico II Di NapoliRecruiting
Naples, Italy, Italy
Azienda Ospedaliero-Universitaria Policlinico Umberto IRecruiting
Rome, Italy, Italy
Ospedale Pediatrico Bambino GesuRecruiting
Rome, Italy, Italy
IRCCS Materno Infantile Burlo GarofoloRecruiting
Trieste, Italy, Italy
Oslo University Hospital HFRecruiting
Oslo, Norway, Norway
Sykehuset I Vestfold HFRecruiting
Tønsberg, Norway, Norway
In Vivo Sp. z o.o.Recruiting
Bydgoszcz, Poland, Poland
Instytut Centrum Zdrowia Matki PolkiRecruiting
Lodz, Poland, Poland
Gabinet Lekarski Bartosz KorczowskiRecruiting
Rzeszów, Poland, Poland
Instytut Pomnik Centrum Zdrowia DzieckaRecruiting
Warsaw, Poland, Poland
CCAB Centro Clinico Academico Braga AssociacaoRecruiting
Braga, Portugal, Portugal
Hospital Pediátrico de CoimbraRecruiting
Coimbra, Portugal, Portugal
Unidade Local De Saude Do Alto Minho E.P.E.Recruiting
Viana do Castelo, Portugal, Portugal
Dr. Victor Gomoiu Clinical Children HospitalRecruiting
Bucharest, Romania, Romania
Spitalul Clinic De Urgenta Pentru Copii Louis Turcanu TimisoaraRecruiting
Timișoara, Romania, Romania
Hospital Germans Trias I PujolRecruiting
Badalona, Spain, Spain
Hospital Universitario Reina SofiaRecruiting
Córdoba, Spain, Spain
Bristol Royal InfirmaryRecruiting
Bristol, United Kingdom
Ninewells HospitalNot Yet Recruiting
Glasgow, United Kingdom
Alder Hey Children's HospitalRecruiting
Liverpool, United Kingdom
Chelsea and Westminster HospitalNot Yet Recruiting
London, United Kingdom
The Newcastle upon Tyne Hospital FTNot Yet Recruiting
Newcastle, United Kingdom
Sheffield Children's HospitalRecruiting
Sheffield, United Kingdom