Clinical Research Directory
Browse clinical research sites, groups, and studies.
OLE Study With Filgotinib in JIA
Sponsor: Alfasigma S.p.A.
Summary
This OLE study is designed to evaluate long-term safety, tolerability, and efficacy of filgotinib in patients with polyarticular or systemic juvenile idiopathic arthritis (pJIA-sJIA) who have completed the treatment period/prolonged treatment period of the parent studies and demonstrated clinical benefit defined as control of disease activity through improvement in signs and symptoms as per Investigator judgement.
Official title: Open-label Extension (OLE), Multiple Dose Study to Evaluate Safety, Tolerability, and Efficacy of Filgotinib in Children and Adolescents From 8 Years to Less Than 18 Years of Age With Juvenile Idiopathic Arthritis (JIA)
Key Details
Gender
All
Age Range
8 Years - 18 Years
Study Type
INTERVENTIONAL
Enrollment
80
Start Date
2026-04-20
Completion Date
2027-12
Last Updated
2026-04-27
Healthy Volunteers
No
Conditions
Interventions
Filgotinib
Investigational product (IP) will be provided as commercially developed film-coated tablets or age-appropriate film-coated tablets for use in pediatric subjects aged at least 8 years and needs to be taken orally once daily (q.d.) at approximately the same time every morning (with or without food)
Locations (4)
Bicetre Hospital
Le Kremlin-Bicêtre, France
Hamburger Zentrum für Kinder- und Jugendrheumatologie
Hamburg, Germany
Asklepios Klinik Sankt Augustin GmbH
Sankt Augustin, Germany
Great Ormond Street Hospital for Children
London, United Kingdom