OLE Study With Filgotinib in JIA (OLE JIA)

April 21, 2026 updated by: Alfasigma S.p.A.

Open-label Extension (OLE), Multiple Dose Study to Evaluate Safety, Tolerability, and Efficacy of Filgotinib in Children and Adolescents From 8 Years to Less Than 18 Years of Age With Juvenile Idiopathic Arthritis (JIA)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Le Kremlin-Bicêtre, France, 94270
        • Not yet recruiting
        • Bicetre Hospital
        • Contact:
          • Isabelle Kone-Paut, Dr.
  • Germany
      • Hamburg, Germany, 22081
        • Recruiting
        • Hamburger Zentrum für Kinder- und Jugendrheumatologie
        • Contact:
          • Ivan Foeldvari, Dr.
      • Sankt Augustin, Germany, 53757
        • Not yet recruiting
        • Asklepios Klinik Sankt Augustin GmbH
        • Contact:
          • Gerd Horneff, Dr
  • United Kingdom
      • London, United Kingdom, WC1N 3JH
        • Not yet recruiting
        • Great Ormond Street Hospital for Children
        • Contact:
          • Sandrine Lacassagne, Dr.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Filgotinib
Drug: Filgotinib
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
Time Frame: From baseline (Day 1) up to Week 78
From baseline (Day 1) up to Week 78

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of subjects with JIA American College of Rheumatology (ACR) 30 response over time.
Time Frame: Week 1, Week 26, Week 52 and Week 78
Week 1, Week 26, Week 52 and Week 78
Percentage of subjects with JIA ACR inactive disease.
Time Frame: Week 1, Week 26, Week 52 and Week 78
Week 1, Week 26, Week 52 and Week 78
Percentage of subjects with JIA ACR clinical remission over time.
Time Frame: Week 1, Week 26, Week 52 and Week 78
Week 1, Week 26, Week 52 and Week 78
Incidence of treatment-emergent uveitis (including severity).
Time Frame: Week 1, Week 26, Week 52, Week 78
Week 1, Week 26, Week 52, Week 78

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alfasigma S.p.A.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 20, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

April 21, 2026

First Submitted That Met QC Criteria

April 21, 2026

First Posted (Actual)

April 27, 2026

Study Record Updates

Last Update Posted (Actual)

April 27, 2026

Last Update Submitted That Met QC Criteria

April 21, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GLPG0634-CL-333
  • 2025-523239-21-00 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Juvenile Idiopathic Arthritis (JIA)

Clinical Trials on Filgotinib

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Azerbaijan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe