OLE Study With Filgotinib in JIA
Condition(s) studied
Investigational drug(s) / intervention(s)
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
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)
| Facility | City | Region | Status |
|---|---|---|---|
| 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 |
More Alfasigma S.p.A. trials in France
Other trials for the same condition
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