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Safety, Tolerability, Pharmacokinetics, and Efficacy of Filgotinib for the Treatment of Polyarticular-course Juvenile Idiopathic Arthritis in Children and Adolescents

NCT07554495 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2026-06-12

No results posted yet for this study

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.

Conditions

  • Polyarticular Course Juvenile Idiopathic Arthritis

Interventions

DRUG

Filgotinib

IP will be provided as commercially developed film-coated tablets or age-appropriate film- coated tablets for use in paediatric subjects aged at least 8 years and needs to be taken orally q.d. at approximately the same time every morning (with or without food)

Sponsors & Collaborators

  • Alfasigma S.p.A.

    lead INDUSTRY

Principal Investigators

  • Catherine Vincent · Alfasigma S.p.A.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
8 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-21
Primary Completion
2027-06-30
Completion
2027-06-30

Countries

  • Belgium
  • Czechia
  • France
  • Germany
  • Hungary
  • Italy
  • Poland
  • Spain
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07554495 on ClinicalTrials.gov