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RECRUITING
NCT07553182
PHASE3

OLE Study With Filgotinib in JIA

Sponsor: Alfasigma S.p.A.

View on ClinicalTrials.gov

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

Interventions

DRUG

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