🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in the UK / NCT07554495
Recruiting Phase 3

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

NCT07554495 · tracked via the Priya Life Science UK tracker
Sponsor
Alfasigma S.p.A.
Phase
Phase 3
Started
2026-05-21
Last updated
2026-06-12

Condition(s) studied

Polyarticular Course Juvenile Idiopathic Arthritis

Investigational drug(s) / intervention(s)

Filgotinib

Filgotinib: IP will be provided as commercially developed film-coated tablets or age-appropriate film- coated tablets for use in paediatric subjects aged at least 8 years and needs to be taken orally q.d. at approximately the same time every morning (with or without food)

Study summary

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.

Eligibility

Sex
ALL
Min age
8 Years
Max age
18 Years
Healthy volunteers
No
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).

Primary outcome measure(s)

Trial sites (14)

FacilityCityRegionStatus
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
Istituto Giannina Gaslini-Ospedale Pediatrico IRCCS Genova Italy Recruiting
Centrum Medyczne Hipokrates S C Elzbieta I Grzegorz Grzesk Bydgoszcz Poland Recruiting
MICS Centrum Medyczne Torun Torun Poland Recruiting
ETG JustMed Warsaw Poland Recruiting
Hospital Sant Joan de Deu Barcelona Spain Recruiting
Bristol Royal Hospital for Children Bristol United Kingdom Recruiting
Leicester Royal Infirmary Leicester United Kingdom Recruiting
Nottingham University Hospitals Queen's Medical Centre Nottingham United Kingdom Recruiting

More Alfasigma S.p.A. trials in the UK

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07554495 on ClinicalTrials.gov ↗ ← All trials in the UK