An Open-Label Extension Study to Evaluate the Safety, Tolerability, and Efficacy of Filgotinib in Children and Adolescents with Juvenile Idiopathic Arthritis
- Trial ID
- 2025-523239-21-00
- Protocol
- GLPG0634-CL-333
- Sponsor
- Alfasigma S.p.A.
Trial statistics
Diseases & Conditions
Objectives
The primary objective of this study is to determine the long-term safety and tolerability of filgotinib in children and adolescents aged 8 to less than 18 years with juvenile idiopathic arthritis. Secondary objectives include:
- Evaluation of long-term efficacy.
- Assessment of the effect on disease remission.
- Evaluation of the long-term effect on the incidence of uveitis.
Participants
This clinical trial involves a total of 9 participants. The study population consists of male and female children and adolescents, specifically aged 8 to less than 18 years, diagnosed with juvenile idiopathic arthritis. Participants were selected based on their previous completion of treatment with filgotinib in specific parent studies and the achievement of clinical benefit at the conclusion of those protocols. Inclusion requires the ability and willingness of the subject or a legal guardian to comply with the protocol requirements. For female subjects of childbearing potential who are sexually active, adherence to contraception or preventive exposure measures is required.
Plans and Procedures
This open-label extension study is designed to evaluate the long-term safety, tolerability, and efficacy of filgotinib in pediatric and adolescent populations. The study focuses on subjects between 8 and 18 years of age diagnosed with juvenile idiopathic arthritis who have previously achieved clinical benefit in specific parent studies. The research methodology involves the administration of oral doses of filgotinib to assess pharmacokinetics and clinical outcomes. The primary objective is to monitor the frequency and severity of treatment-emergent adverse events, including serious adverse events, that may lead to discontinuation. Secondary endpoints include the percentage of subjects achieving ACR clinical remission, inactive disease, or an ACR 30 response, as well as the incidence of uveitis and the duration of response. The study is expected to conclude by November 2029.
Treatment
The experimental treatment consists of filgotinib administered as a film-coated mini-tablet in a 100 mg dose via oral administration.
The experimental treatment also includes Jyseleca provided as film-coated tablets. This medication is administered orally at dosages of either 100 mg or 200 mg.
Efficacy
The assessment of efficacy in patients with juvenile idiopathic arthritis involves several secondary endpoints. The evaluation includes determining the percentage of subjects achieving the American College of Rheumatology (ACR) 30 response, inactive disease, and clinical remission over time.
Additional efficacy parameters include the duration of response and the incidence and severity of treatment-emergent uveitis.
Inclusion and Exclusion Criteria
Inclusion Criteria
- Subject must have completed treatment with filgotinib in at least one parent study (GLPG0634-CL-131, GLPG0634-CL-329, or GLPG0634-CL-328) 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 judgment.
- 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.
Trial Status by Country
| Country | Status | Start of Recruitment | Planned Patients |
|---|---|---|---|
 France | Not Yet Recruiting | 10 Apr 2026 | 9 |
 Germany | Recruiting | 10 Apr 2026 | 9 |
Sites & Investigators
Investigational Products
Details about the medicinal products being studied in this clinical trial.
| Product Name | Role in Trial | Formulation | Administration | Max Daily Dose | Treatment Duration | EU MP Number |
|---|---|---|---|---|---|---|
Jyseleca 200 mg film-coated tablets | Test | FILM-COATED TABLETS | ORAL USE | 200 | 18 | PRD11572414 |
Jyseleca 100 mg film-coated tablets | Test | FILM-COATED TABLETS | ORAL USE | 100 | 18 | PRD11572266 |
GLPG0634 | Test | FILM-COATED MINI-TABLET | ORAL USE | 100 | 18 | PRD10583347 |