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NCT Number: NCT07553182

OLE Study With Filgotinib in JIA

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.

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Key information

Conditions

Juvenile Idiopathic Arthritis (JIA) Arthritis Arthritis, Juvenile Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

8 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Bicetre Hospital, Le Kremlin-Bicêtre, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Filgotinib

Drug

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 outcomes

  1. 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 outcomes

  1. 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

  2. Percentage of subjects with JIA ACR inactive disease.

    Time frame: Week 1, Week 26, Week 52 and Week 78

  3. Percentage of subjects with JIA ACR clinical remission over time.

    Time frame: Week 1, Week 26, Week 52 and Week 78

  4. Incidence of treatment-emergent uveitis (including severity).

    Time frame: Week 1, Week 26, Week 52, Week 78

Study contacts

Contact information is provided by the study sponsor or research team.

Catherine Vincent

CONTACT

[email protected]

00800 7878 1345

Sponsors and collaborators

Lead sponsor

Alfasigma S.p.A.

Industry

Registry information

Official study 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)

Acronym: OLE JIA

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 27, 2026
Registry last updated
Apr 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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