Safety, Tolerability, Pharmacokinetics, and Efficacy of Filgotinib for the Treatment of Polyarticular-course Juvenile Idiopathic Arthritis in Children and Adolescents

Recruiting now · Phase 3

Conditions studied: Polyarticular Course Juvenile Idiopathic Arthritis

In brief

This is a multicenter Phase 3, open-label, single-arm study to evaluate the safety, tolerability, PK, and efficacy of orally administered filgotinib for up to 18 weeks.

Key facts

Study ID: NCT07554495
Run by: Alfasigma S.p.A.
People needed: 65
Starts: 2026-05-21
Expected to finish: 2027-06-01
Last updated by the study team: 2026-06-12

Who can join

Age: 8 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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 is running

UZ Leuven — Leuven, Belgium (enrolling)
Vseobecna fakultni nemocnice v Praze — Prague, Czechia (enrolling)
Hôpital Bicêtre — Le Kremlin-Bicêtre, France (enrolling)
Charité - Campus Virchow-Klinikum — Berlin, Germany (enrolling)
Hamburger Zentrum fuer Kinder und Jugendrheumatologie — Hamburg, Germany (enrolling)
Pecsi Tudomanyegyetem Klinikai Kozpont — Pécs, Hungary (enrolling)
Istituto Giannina Gaslini-Ospedale Pediatrico IRCCS — Genova, Italy (enrolling)
Centrum Medyczne Hipokrates S C Elzbieta I Grzegorz Grzesk — Bydgoszcz, Poland (enrolling)
MICS Centrum Medyczne Torun — Torun, Poland (enrolling)
ETG JustMed — Warsaw, Poland (enrolling)
Hospital Sant Joan de Deu — Barcelona, Spain (enrolling)
Bristol Royal Hospital for Children — Bristol, United Kingdom (enrolling)
Leicester Royal Infirmary — Leicester, United Kingdom (enrolling)
Nottingham University Hospitals Queen's Medical Centre — Nottingham, United Kingdom (enrolling)

Full record on ClinicalTrials.gov

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