OLE Study With Filgotinib in JIA

Официальное название

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)

Обзор

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.

Вмешательства

• Препарат 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)

Первичные конечные точки

• 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. [Срок оценки: From baseline (Day 1) up to Week 78]

Вторичные конечные точки (4)

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

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Германия · 2 центра

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

Франция · 1 центр

• Bicetre Hospital — Le Kremlin-Bicêtre

Великобритания · 1 центр

• Great Ormond Street Hospital for Children — London

Идентификаторы

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

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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