Filgotinib for children with polyarticular juvenile idiopathic arthritis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter Phase 3, open-label, single-arm trial evaluating safety, tolerability, pharmacokinetics, and efficacy of oral filgotinib in pediatric patients aged 8 to under 18 with moderately to severely active polyarticular JIA. Eligible participants may have extended oligoarthritis, RF-positive or RF-negative polyarthritis, psoriatic arthritis, or enthesitis-related arthritis and must have inadequate response to current therapy. The study involves up to 18 weeks of filgotinib treatment and will monitor safety and PK alongside clinical response. It is sponsored by Alfasigma S.p.A. with participating centers in Leuven, Prague, and Paris regions.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 ICF and assent (if required per local regulation) as approved by the Independent Ethics Committee / Institutional Review Board, prior to any screening 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.
* Subject must meet the ILAR classification and have moderately to severely active disease for one of the following categories that is not adequately controlled with his/her current therapy (see Protocol Appendix 1 for disease activity assessment criteria):

  * Extended oligoarthritis (i.e. affecting a total of more than 4 joints after the first 6 months of disease)
  * RF-positive polyarthritis
  * RF-negative polyarthritis
  * PsA
  * ERA
* Subject with intolerance or a history of inadequate response to at least one of the following medications for the treatment of pJIA, administered for at least 3 months, based on current treatment guidelines: conventional synthetic disease modifying anti rheumatic drugs (csDMARDs; including methotrexate) and/or biologic disease modifying anti-rheumatic drugs (bDMARDs) administered per local label, and/or non steroidal anti-inflammatory drugs for ERA and PsA subtypes.
* 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 protocol.

Exclusion Criteria:

* Subject with a body weight \<15 kg.
* Subject with persistent oligoarthritis (i.e. affecting not more than 4 joints throughout the disease course).
* Subject with undifferentiated arthritis.
* Subject with anterior uveitis (active or uncontrolled) ≤12 weeks prior to baseline.
* Subject with systemic JIA.
* Subject with any other rheumatic disease, inflammatory, or immunologic disease (e.g. inflammatory bowel disease, hypogammaglobulinemia, or systemic lupus erythematosus).
* Subject has 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.
* Subject has an active infection. • Subject with a history of complicated herpes zoster infection (with multi dermatomal, disseminated, ophthalmic, or central nervous system involvement).

Where it's running

• UZ Leuven
  Leuven, Belgium Recruiting
• Vseobecna fakultni nemocnice v Praze
  Prague, Czechia Recruiting
• Hôpital Bicêtre
  Le Kremlin-Bicêtre, France Recruiting
• Charité - Campus Virchow-Klinikum
  Berlin, Germany Recruiting
• Hamburger Zentrum fuer Kinder und Jugendrheumatologie
  Hamburg, Germany Recruiting
• Pecsi Tudomanyegyetem Klinikai Kozpont
  Pécs, Hungary Recruiting

Study contacts

• Study coordinator: Medical Information
• Email: medicalinfo@alfasigma.com
• Phone: 00800 7878 1345

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Using advanced MRI to understand how Filgotinib relieves pain in rheumatoid arthritis

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• Better After Choosing: Filgotinib versus TNF inhibitor options for rheumatoid arthritis

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• Sequential medication options after TNFi failure in juvenile idiopathic arthritis

  This test looks at whether switching to one of three non‑TNFi medicines or trying a different TNFi helps children aged 2–17 with polyarticular‑course JIA who didn't improve on their first TNFi.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.