OLE Study With Filgotinib in JIA

NCT07553182 | Recruiting Phase 3

• 2 other identifiers: GLPG0634-CL-3332025-523239-21-00
• Study Type: interventional
• Target: 80
• Locations: 3 countries
• Sites: 4

Brief Summary

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.

Conditions

Juvenile Idiopathic Arthritis (JIA)

Outcome Measures

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.

  From baseline (Day 1) up to Week 78

Secondary Outcomes (4)

• Percentage of subjects with JIA American College of Rheumatology (ACR) 30 response over time.

  Week 1, Week 26, Week 52 and Week 78

• Percentage of subjects with JIA ACR inactive disease.

  Week 1, Week 26, Week 52 and Week 78

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

  Week 1, Week 26, Week 52 and Week 78

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

  Week 1, Week 26, Week 52, Week 78

Study Arms (1)

Filgotinib

EXPERIMENTAL

Filgotinib

Drug: Filgotinib

Interventions

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)

Filgotinib

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Alfasigma S.p.A.: lead

Study Sites (4)

Bicetre Hospital

Le Kremlin-Bicêtre, 94270, France

NOT YET RECRUITING

Hamburger Zentrum für Kinder- und Jugendrheumatologie

Hamburg, 22081, Germany

RECRUITING

Asklepios Klinik Sankt Augustin GmbH

Sankt Augustin, 53757, Germany

NOT YET RECRUITING

Great Ormond Street Hospital for Children

London, WC1N 3JH, United Kingdom

NOT YET RECRUITING

MeSH Terms

Conditions

Arthritis, Juvenile

Interventions

GLPG0634

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Catherine Vincent

CONTACT

00800 7878 1345; medicalinfo@alfasigma.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2026
• First Posted: April 27, 2026
• Study Start: April 20, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1); DE (2); GB (1)