The aim of this study is to evaluate the efficacy, safety, tolerability, and pharmacokinetics (PK) of filgotinib as a treatment for UC in children and adolescents aged from 8 to less than 18 years. Approximately 80 subjects from 8 to \<18 years of age with moderately to severely active UC, including a minimum of 8 subjects from 8 to \<12 years of age, will be enrolled in this study. During the study, eligible subjects will take the investigational product (IP) on-site at Week 4, Week 10, and Week 22 (in the morning; with or without food). On all other days, subjects will take IP at home (in the morning; with or without food). Subjects who do not achieve mMCS remission and/or MCS response at Week 10 will continue with induction treatment until Week 22. Subjects who do not achieve PUCAI remission at Week 22 will be permanently discontinued from the study. Subjects will all receive a filgotinib dose targeting the same systemic exposure as that observed in adults with UC treated with 200 mg q.d.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
80
IP will be provided as commercially developed film-coated tablets (100 and 200 mg strength) or reduced-strength (65 mg) age-appropriate film-coated tablets for use in pediatric 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).
Association Hospitaliere De Bruxelles Hopital Universitaire Des Enfants Reine Fabiola
Brussels, Brussels Capital, Belgium
NOT_YET_RECRUITINGCentre Hospitalier Regional De La Citadelle
Liège, Liege, Belgium
NOT_YET_RECRUITINGCentre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur
Namur, Namur, Belgium
RECRUITINGKlinicki Bolnicki Centar Osijek
Osijek, Croatia, Croatia
Efficacy of filgotinib in induction of remission and maintenance of effect in pediatric subjects with ulcerative colitis (UC)
Proportion of subjects achieving clinical remission based on modified Mayo Clinical Score (mMCS)
Time frame: Week 10
subjects with ulcerative colitis (UC)
Proportion of subjects achieving clinical remission based on mMCS
Time frame: Week 58
Safety and tolerability of filgotinib in pediatric subjects with UC
Incidence of treatment-emergent adverse events (TEAEs), adverse events of interest, and laboratory abnormalities through follow-up
Time frame: Week 62
Safety and tolerability of filgotinib in pediatric subjects with UC
Change from baseline in body mass index (BMI)
Time frame: Week 58
Safety and tolerability of filgotinib in pediatric subjects with U
Change from baseline in height velocity
Time frame: Week 58
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Children's Hospital Zagreb
Zagreb, Croatia, Croatia
RECRUITINGUniversity Hospital Centre Zagreb
Zagreb, Croatia, Croatia
RECRUITINGHospital Femme Mere Enfant
Bron, France, France
RECRUITINGCentre Hospitalier Universitaire De Dijon
Dijon, France, France
RECRUITINGHopital Saint Vincent de Paul - GHICL Lille
Lille, France, France
RECRUITINGCHU de Montpellier
Montpellier, France, France
RECRUITING...and 37 more locations