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

Name: Safety, Tolerability, Pharmacokinetics, and Efficacy of Filgotinib for the Treatment of Polyarticular-course Juvenile Idiopathic Arthritis in Children and Adolescents — clinical trial record (NCT07554495)
Creator: DataLookout
License: https://creativecommons.org/licenses/by/4.0/

Study acronym: GALAHOPPER

StatusRecruiting

PhasePhase 3

SponsorAlfasigma S.p.A.

Started2026-05-21

View on ClinicalTrials.gov ↗

Amendment history

2026-06-10

Study Status, Contacts/Locations v1

Recruitment opened

Trial sites expanded: 1 → 14 locations

Start dateestimated 2026-05→confirmed 2026-05-21

2026-04-21

Original filing

Alfasigma S.p.A.

10 trials monitored

See all monitored trials

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.

Trial Details

NCT Number	NCT07554495
Lead Sponsor	Alfasigma S.p.A.
Conditions	Polyarticular Course Juvenile Idiopathic Arthritis
Enrollment	65 participants
Start Date	2026-05-21
Primary Completion	2027-06 (estimated)
Study Completion	2027-06 (estimated)
Updated on ClinicalTrials.gov	2026-06-12