OLE Study With Filgotinib in JIA

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)

Overview

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.

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)

Primary outcome measures

• 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. [Time frame: From baseline (Day 1) up to Week 78]

Secondary outcome measures (4)

• Percentage of subjects with JIA American College of Rheumatology (ACR) 30 response over time. [Time frame: Week 1, Week 26, Week 52 and Week 78]
• Percentage of subjects with JIA ACR inactive disease. [Time frame: Week 1, Week 26, Week 52 and Week 78]
• Percentage of subjects with JIA ACR clinical remission over time. [Time frame: Week 1, Week 26, Week 52 and Week 78]
• Incidence of treatment-emergent uveitis (including severity). [Time frame: Week 1, Week 26, Week 52, Week 78]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

Germany · 2 centers

• Hamburger Zentrum für Kinder- und Jugendrheumatologie — Hamburg
• Asklepios Klinik Sankt Augustin GmbH — Sankt Augustin

France · 1 center

• Bicetre Hospital — Le Kremlin-Bicêtre

United Kingdom · 1 center

• Great Ormond Street Hospital for Children — London

Identifiers

NCT: NCT07553182 · GLPG0634-CL-333 · 2025-523239-21-00

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗