Open Label Extension (OLE), multiple dose study to evaluate pharmacokinetics, 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).

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-523239-21-00

Enrollment

Registered

2026-04-01

Start date

Unknown

Completion date

Unknown

Last updated

2026-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Juvenile idiopathic arthritis

Brief summary

Frequency and severity of treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (SAEs), and TEAEs leading to treatment discontinuation at each visit throughout the duration of the study.

Detailed description

Percentage of subjects with JIA American College of Rheumatology (ACR) 30 response over time., Percentage of subjects with JIA ACR inactive disease., Percentage of subjects with JIA ACR clinical remission over time., Incidence of treatment-emergent uveitis (including severity)., Duration of response.

Interventions

DRUGGLPG0634

DRUGJyseleca 200 mg film-coated tablets

DRUGJyseleca 100 mg film-coated tablets

Eligibility

Sex/Gender

All

Age

0 Years to 17 Years

Design outcomes

Primary

Measure	Time frame
Frequency and severity of treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (SAEs), and TEAEs leading to treatment discontinuation at each visit throughout the duration of the study.	—

Secondary

Measure	Time frame
Percentage of subjects with JIA American College of Rheumatology (ACR) 30 response over time., Percentage of subjects with JIA ACR inactive disease., Percentage of subjects with JIA ACR clinical remission over time., Incidence of treatment-emergent uveitis (including severity)., Duration of response.	—

Outcome results

None listed

Source: EU CTIS · Data processed: Apr 2, 2026