NCT07553182 OLE Study With Filgotinib in JIA
| NCT ID | NCT07553182 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Alfasigma S.p.A. |
| Condition | Juvenile Idiopathic Arthritis (JIA) |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2026-04-20 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 80 participants in total. It began in 2026-04-20 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07553182 clinical trial?
This trial is open to participants of all sexes, aged 8 Years or older, up to 18 Years, studying Juvenile Idiopathic Arthritis (JIA). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07553182 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 80 participants.
Is NCT07553182 currently recruiting?
Yes, NCT07553182 is actively recruiting participants. Contact the research team at medicalinfo@alfasigma.com for enrollment information.
Where is the NCT07553182 trial being conducted?
This trial is being conducted at Le Kremlin-Bicêtre, France, Hamburg, Germany, Sankt Augustin, Germany, London, United Kingdom.
Who is sponsoring the NCT07553182 clinical trial?
NCT07553182 is sponsored by Alfasigma S.p.A.. The trial plans to enroll 80 participants.