Actively Recruiting
Open-label Extension Study to Evaluate Safety, Tolerability, and Efficacy of Filgotinib in Children and Adolescents Aged 8 to Less Than 18 Years With Juvenile Idiopathic Arthritis
Led by Alfasigma S.p.A. · Updated on 2026-04-27
80
Participants Needed
4
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating filgotinib in children and adolescents aged 8 to less than 18 years with juvenile idiopathic arthritis (JIA) who previously showed clinical benefit from filgotinib in earlier studies. This open-label extension (OLE) phase 3 study aims to assess the long-term safety, tolerability, and efficacy of filgotinib in this population. Participants have polyarticular or systemic JIA and must have completed prior treatment periods with documented improvement in disease activity. Participants will receive filgotinib as an investigational oral drug in the form of film-coated tablets suitable for their age. The medication is taken once daily in the morning, with or without food, over an extended period. The study includes continuous monitoring for adverse events and effectiveness, with evaluations scheduled through week 78. Throughout the study, participants will be monitored for treatment-emergent adverse events, including serious side effects and those leading to stopping treatment. Effectiveness will be measured using JIA American College of Rheumatology (ACR) response criteria and disease remission status at several time points up to week 78. Safety assessments include tracking incidences of uveitis. The total participation duration spans from baseline through week 78, with regular visits and assessments to monitor health and treatment impact.
CONDITIONS
Brief Title
OLE Study With Filgotinib in JIA
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
- Subject must sign and date the informed consent form and assent (if required) prior to any protocol evaluations
- Female or male subject aged 8 to less than 18 years on the date of signing consent and assent (if required)
- Female subjects of childbearing potential who are sexually active must agree to use contraception or preventive measures as described in the study protocol
You will not qualify if you...
- Development of any condition during the parent study that would prevent safe continuation
- Pregnancy
- Active infection that is clinically significant according to the Investigator's judgement
- Known hypersensitivity to components of the study therapy
- Any condition or circumstance, including abnormal lab results, that may make the subject unlikely or unable to complete the study or comply with study procedures
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
screening and enrollment visit
Duration - Up to 78 weeks
Participants take Filgotinib orally once daily to evaluate its safety, tolerability, and efficacy in treating Juvenile Idiopathic Arthritis.
Visits at Week 1, Week 26, Week 52, and Week 78
Trial Site Locations
Total: 4 locations
1
Bicetre Hospital
Le Kremlin-Bicêtre, France, 94270
Not Yet Recruiting
2
Hamburger Zentrum für Kinder- und Jugendrheumatologie
Hamburg, Germany, 22081
Actively Recruiting
3
Asklepios Klinik Sankt Augustin GmbH
Sankt Augustin, Germany, 53757
Not Yet Recruiting
4
Great Ormond Street Hospital for Children
London, United Kingdom, WC1N 3JH
Not Yet Recruiting
Research Team
C
Catherine Vincent
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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