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Study to Measure Filgotinib in the Blood of Children and Teenagers With Arthritis Taking Filgotinib (SCALESIA)
Sponsor: Alfasigma S.p.A.
Summary
A Study to evaluate the pharmacokinetics, safety, and tolerability in paediatric population for treating juvenile idiopathic arthritis (JIA).
Official title: An Open-label, Multiple Dose, Multicenter Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Filgotinib in Children and Adolescents From 8 to Less Than 18 Years of Age With Juvenile Idiopathic Arthritis
Key Details
Gender
All
Age Range
8 Years - 18 Years
Study Type
INTERVENTIONAL
Enrollment
10
Start Date
2024-05-13
Completion Date
2026-08
Last Updated
2025-12-10
Healthy Volunteers
No
Conditions
Interventions
Filgotinib
Film-coated mini-tablets administered orally once daily
Filgotinib
Commercially developed film-coated tablet administered orally once daily
Locations (10)
CHU Amiens - Hopital Nord
Amiens, France
Bicêtre University Hospital
Le Kremlin-Bicêtre, France
Children's university hospital Charité, Campus Virchow, SPZ
Berlin, Germany
Hamburger Zentrum fur Kinder und Jugendrheumatologie
Hamburg, Germany
Asklepios Klinik Sankt Augustin GmbH
Sankt Augustin, Germany
Malopolskie Badania Kliniczne
Krakow, Poland
Hospital Universitari Vall d'Hebron
Barcelona, Spain
Hospital Sant Joan de Deu
Barcelona, Spain
Hospital Universitari i Politecnic La Fe
Valencia, Spain
Great Ormond Street Hospital
London, United Kingdom