Open-label extension with filgotinib for juvenile idiopathic arthritis

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 long-term open-label extension sees if filgotinib stays safe and continues to control symptoms in children aged 8–17 with polyarticular or systemic juvenile idiopathic arthritis who benefited from earlier treatment.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 8 Years to 18 Years
• Sex: All
• Sponsor: Alfasigma S.p.A. (industry)
• Drugs / interventions: filgotinib
• Locations: 4 sites (Le Kremlin-Bicêtre and 3 other locations)
• Trial ID: NCT07553182 on ClinicalTrials.gov

What this trial studies

This open-label extension enrolls children aged 8 to <18 years with polyarticular or systemic juvenile idiopathic arthritis who completed a parent filgotinib study and demonstrated clinical benefit. Participants continue on filgotinib and are followed over time with regular clinic visits to monitor long-term safety, tolerability, and sustained control of signs and symptoms. The protocol includes safety monitoring by clinical assessment and laboratory testing and excludes patients who developed conditions during the parent study that would preclude safe continuation, those with active significant infection, or pregnancy. Data collected will document adverse events, laboratory abnormalities, and clinical measures of disease activity to characterize extended treatment outcomes.

Who should consider this trial

Good fit: Ideal candidates are children 8 to <18 years with polyarticular or systemic JIA who completed a parent filgotinib study, demonstrated clinical benefit, and can adhere to study visits and contraceptive requirements if applicable.

Not a fit: Patients who did not respond to filgotinib in the parent studies, who developed disqualifying safety issues, who have active significant infection, or who are pregnant would be unlikely to benefit from this extension.

Why it matters

Potential benefit: If successful, this extension could show that long-term filgotinib keeps disease under control and has an acceptable safety profile in children, supporting continued use when needed.

How similar studies have performed: Adult rheumatoid arthritis trials and the pediatric parent filgotinib studies have shown clinical benefit with manageable safety, supporting the rationale for this open-label extension.

Eligibility criteria

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

Where this trial is running

Le Kremlin-Bicêtre and 3 other locations

• Bicetre Hospital — Le Kremlin-Bicêtre, France (NOT_YET_RECRUITING)
• Hamburger Zentrum für Kinder- und Jugendrheumatologie — Hamburg, Germany (RECRUITING)
• Asklepios Klinik Sankt Augustin GmbH — Sankt Augustin, Germany (NOT_YET_RECRUITING)
• Great Ormond Street Hospital for Children — London, United Kingdom (NOT_YET_RECRUITING)

Study contacts

• Study coordinator: Catherine Vincent

Conditions: Juvenile Idiopathic Arthritis