Galapeduca
Research type
Research Study
Full title
A multicenter study to evaluate the efficacy, safety, tolerability, and pharmacokinetics of filgotinib, with single arm induction and maintenance, in pediatric subjects (8 to <18 years of age) with moderately to severely active ulcerative colitis.
IRAS ID
1009890
Contact name
Alexandra Mangili
Contact email
Sponsor organisation
Alfasigma S.p.A.
Clinicaltrials.gov Identifier
Research summary
Ulcerative colitis (UC) is a an inflammatory disease that causes inflammation and ulcers in the digestive tract. Ulcerative colitis affects the innermost lining of the large intestine, also called the colon, and rectum.
The purpose of this study is to evaluate the effects and safety of study drug (Filgotinib) in children with UC.
Approximately 80 participants older than 8 years and younger than 18 years will receive the study drug orally.
The total study duration for each participant will be up to 66 weeks as follows:
Screening period (lasting up to 4 weeks)
Treatment period (lasting up to 58 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
East of England - Cambridge South Research Ethics Committee
REC reference
25/EE/0018
Date of REC Opinion
5 Mar 2025
REC opinion
Further Information Favourable Opinion