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Safety, Tolerability, Pharmacokinetics, and Efficacy of Filgotinib for the Treatment of Polyarticular-course Juvenile Idiopathic Arthritis in Children and Adolescents
Sponsor: Alfasigma S.p.A.
Summary
This is a multicenter Phase 3, open-label, single-arm study to evaluate the safety, tolerability, PK, and efficacy of orally administered filgotinib for up to 18 weeks.
Official title: Multicenter, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of Filgotinib in Children and Adolescents From 8 Years to Less Than 18 Years of Age With Polyarticular-course Juvenile Idiopathic Arthritis
Key Details
Gender
All
Age Range
8 Years - 18 Years
Study Type
INTERVENTIONAL
Enrollment
65
Start Date
2026-05-21
Completion Date
2027-06
Last Updated
2026-06-12
Healthy Volunteers
No
Interventions
Filgotinib
IP will be provided as commercially developed film-coated tablets or age-appropriate film- coated tablets for use in paediatric 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)
Locations (14)
UZ Leuven
Leuven, Belgium
Vseobecna fakultni nemocnice v Praze
Prague, Czechia
Hôpital Bicêtre
Le Kremlin-Bicêtre, France
Charité - Campus Virchow-Klinikum
Berlin, Germany
Hamburger Zentrum fuer Kinder und Jugendrheumatologie
Hamburg, Germany
Pecsi Tudomanyegyetem Klinikai Kozpont
Pécs, Hungary
Istituto Giannina Gaslini-Ospedale Pediatrico IRCCS
Genova, Italy
Centrum Medyczne Hipokrates S C Elzbieta I Grzegorz Grzesk
Bydgoszcz, Poland
MICS Centrum Medyczne Torun
Torun, Poland
ETG JustMed
Warsaw, Poland
Hospital Sant Joan de Deu
Barcelona, Spain
Bristol Royal Hospital for Children
Bristol, United Kingdom
Leicester Royal Infirmary
Leicester, United Kingdom
Nottingham University Hospitals Queen's Medical Centre
Nottingham, United Kingdom