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Recruiting Phase 3

OLE Study With Filgotinib in JIA

NCT07553182 · tracked via the Priya Life Science France tracker
Phase
Phase 3
Started
2026-04-20
Last updated
2026-08-10

Condition(s) studied

Juvenile Idiopathic Arthritis (JIA)

Investigational drug(s) / intervention(s)

Filgotinib →

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)

Study 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.

Eligibility

Sex
ALL
Min age
8 Years
Max age
18 Years
Healthy volunteers
No
Inclusion Criteria: * Subject must have completed treatment with filgotinib in at least one parent study and achieved a clinical benefit at the end of the parent protocols * Subject and/or parent/legal guardian must be able and willing to comply with the clinical study protocol requirements and must sign and date the informed consent form and assent (if required per local regulation) as approved by the Independent Ethics Committee/ Institutional Review Board, prior to any protocol evaluations * Female or male subject 8 to \<18 years of age, on the date of signing the informed consent and assent (per local regulation) form * Female subject of childbearing potential who is sexually active and at risk for pregnancy must agree to use contraception/preventive exposure measures as described in the clinical study protocol. Exclusion Criteria: * Development of any condition during the parent study that would preclude safe continuation * Pregnancy * Active infection that is clinically significant, as per Investigator's judgement * Subject with known hypersensitivity to the components of potential study therapy * Subjects with any condition or circumstances (including abnormalities in laboratory parameters) that, in the opinion of the investigator, may make a subject unlikely or unable to complete the study or comply with study procedures and requirements

Primary outcome measure(s)

  • Frequency and severity of treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (SAEs), and TEAEs leading to treatment discontinuation at each visit throughout the duration of the study. — From baseline (Day 1) up to Week 78

Trial sites (4)

FacilityCityRegionStatus
Bicetre Hospital Le Kremlin-Bicêtre France Recruiting
Hamburger Zentrum für Kinder- und Jugendrheumatologie Hamburg Germany Recruiting
Asklepios Klinik Sankt Augustin GmbH Sankt Augustin Germany Not Yet Recruiting
Great Ormond Street Hospital for Children London United Kingdom Not Yet Recruiting

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07553182 on ClinicalTrials.gov ↗ ← All trials in France