Safety, Tolerability, Pharmacokinetics, and Efficacy of Filgotinib for the Treatment of Polyartic… (NCT07554495) | Clinical Trial Compass
Not Yet RecruitingPhase 3
Safety, Tolerability, Pharmacokinetics, and Efficacy of Filgotinib for the Treatment of Polyarticular-course Juvenile Idiopathic Arthritis in Children and Adolescents
United Kingdom65 participantsStarted 2026-05
Plain-language summary
This is a multicenter Phase 3, open-label, single-arm study to evaluate the safety, tolerability, PK, and efficacy of orally administered filgotinib for up to 18 weeks.
Who can participate
Age range8 Years – 18 Years
SexALL
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Inclusion Criteria:
* 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 ICF and assent (if required per local regulation) as approved by the Independent Ethics Committee / Institutional Review Board, prior to any screening 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.
* Subject must meet the ILAR classification and have moderately to severely active disease for one of the following categories that is not adequately controlled with his/her current therapy (see Protocol Appendix 1 for disease activity assessment criteria):
* Extended oligoarthritis (i.e. affecting a total of more than 4 joints after the first 6 months of disease)
* RF-positive polyarthritis
* RF-negative polyarthritis
* PsA
* ERA
* Subject with intolerance or a history of inadequate response to at least one of the following medications for the treatment of pJIA, administered for at least 3 months, based on current treatment guidelines: conventional synthetic disease modifying anti rheumatic drugs (csDMARDs; including methotrexate) and/or biologic disease modifying anti-rheumatic drugs (bDMARDs) administered per local label, and/or non steroidal anti-inflammatory drugs for ERA and PsA subtypes.
* Female subject of childbearing potential who is sexually active and at risk for pregnancy must agree to use contra…
What they're measuring
1
Frequency and severity of treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (SAEs), and TEAEs leading to treatment discontinuation
Timeframe: From baseline (Day 1) the study up to Week 22