GALAHOPPER
Research type
Research Study
Full title
Multicenter, open-label study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of filgotinib in children and adolescents from 8 years to less than 18 years of age with polyarticular-course juvenile idiopathic arthritis
IRAS ID
1012886
Contact name
Catherine Vincent
Contact email
Sponsor organisation
Alfasigma S.p.A.
Clinicaltrials.gov Identifier
NCT07554495
Research summary
Juvenile idiopathic arthritis (JIA) is an acquired inflammatory disease and one of the most common rheumatic diseases in childhood. It typically causes joint pain and inflammation of the joints. Inflammation may affect other organs such as heart, lungs or lymphnodes in the systemic form of JIA.
The purpose of this study is to access the safety and tolerability of Filgotinib in participants from 8 to less than 18 years of age with polyarticular-course juvenile idiopathic arthritis (pJIA).
Approximately 65 participants older than 8 years and younger than 18 years will participate and will receive the study drug orally.
The total study duration for each participant will be up to 26 weeks as follows:
- Screening period lasting up to 4 weeks (1 visit)
- Open-label treatment period: 18 weeks with 5 visits
- Safety follow-up (FU) period (if not continuing in the long-term extension [LTE] study): 4 weeks after the last intake of investigational product (IP)
All participants will get filgotinib. The dose participants will get depends on weight.
If participants weigh,
• 15 to less than or equal 20 kilogram (kg): participants will get 65 milligram (mg) of filgotinib a day, given as 26 minitablets
• 20 to 50 kg: participants will get one tablet (pill) or minitablets of 100 mg of filgotinib a day
• More than 50 kg: participants will get one tablet of 200 mg of filgotinib a dayREC name
London - Hampstead Research Ethics Committee
REC reference
25/LO/0915
Date of REC Opinion
19 Feb 2026
REC opinion
Further Information Favourable Opinion