SCALESIA
Research type
Research Study
Full title
An open-label, multiple dose, multicenter study to evaluate the pharmacokinetics, safety, and tolerability of filgotinib in children and adolescents from 8 to less than 18 years of age with juvenile idiopathic arthritis.
IRAS ID
1008389
Contact name
Magdalena Petkova
Contact email
Sponsor organisation
Galapagos
ISRCTN Number
N/A
Clinicaltrials.gov Identifier
N/A
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 see how the study drug (Filgotinib) enters the blood, is eliminated to determine the optimal dose to be used by patients and to assess if it is safe to use in children and teenagers with JIA.
Approximately 10 participants older than 8 years and younger than 18 years will participate across 5 countries globally (including the UK) and will receive the study drug orally.
The total study duration for each participant will be up to maximum of 100 weeks (Up to 17 Hospital Visits and 10 Phone call) as follows:
Screening period (lasting up to 4 weeks)
Treatment period (lasting up to 12-92 weeks)
Follow up period (1 visit 4 weeks after last administration of the study drug)All participants will get filgotinib. The dose participants will get depends on weight.
If participants weigh,
• 15 to less than 25 kilogram (kg): participants will get 65 milligram (mg) of filgotinib a day, given as 26 minitablets
• 25 to 60 kg: participants will get one tablet (pill) of 100 mg of filgotinib a day
• More than 60 kg: participants will get one tablet of 200 mg of filgotinib a dayREC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
23/NW/0307
Date of REC Opinion
20 Nov 2023
REC opinion
Further Information Favourable Opinion