RecruitingPhase 3NCT07554495

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

Multicenter, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of Filgotinib in Children and Adolescents From 8 Years to Less Than 18 Years of Age With Polyarticular-course Juvenile Idiopathic Arthritis


Sponsor

Alfasigma S.p.A.

Enrollment

65 participants

Start Date

May 21, 2026

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 8 YearsMax Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Filgotinib for people with polyarticular course juvenile idiopathic arthritis. The study is currently recruiting participants at 14 locations. People eligible for this study include aged 8 Years to 18 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGFilgotinib

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)


Locations(14)

UZ Leuven

Leuven, Belgium

Vseobecna fakultni nemocnice v Praze

Prague, Czechia

Hôpital Bicêtre

Le Kremlin-Bicêtre, France

Charité - Campus Virchow-Klinikum

Berlin, Germany

Hamburger Zentrum fuer Kinder und Jugendrheumatologie

Hamburg, Germany

Pecsi Tudomanyegyetem Klinikai Kozpont

Pécs, Hungary

Istituto Giannina Gaslini-Ospedale Pediatrico IRCCS

Genova, Italy

Centrum Medyczne Hipokrates S C Elzbieta I Grzegorz Grzesk

Bydgoszcz, Poland

MICS Centrum Medyczne Torun

Torun, Poland

ETG JustMed

Warsaw, Poland

Hospital Sant Joan de Deu

Barcelona, Spain

Bristol Royal Hospital for Children

Bristol, United Kingdom

Leicester Royal Infirmary

Leicester, United Kingdom

Nottingham University Hospitals Queen's Medical Centre

Nottingham, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT07554495