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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
65
IP will be provided as commercially developed film-coated tablets or age-appropriate film- coated tablets for use in paediatric 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)
UZ Leuven
Leuven, Belgium
RECRUITINGVseobecna fakultni nemocnice v Praze
Prague, Czechia
Frequency and severity of treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (SAEs), and TEAEs leading to treatment discontinuation
Time frame: From baseline (Day 1) the study up to Week 22
Percentage of subjects with juvenile idiopathic arthritis (JIA) American College of Rheumatology (ACR) 30 response
Time frame: Week 12 and Week 18
Percentage of subjects with JIA ACR inactive disease
Time frame: Week 12 and Week 18
Change from baseline in Juvenile Arthritis Disease Activity Score (JADAS)-27 erythrocyte sedimentation rate (ESR)
Time frame: Week 12 and Week 18
Change from baseline in Juvenile Arthritis Disease Activity Score JADAS-27 C-reactive protein (CRP)
Time frame: Week 12 and Week 18
Incidence of uveitis at various timepoints (including occurrence, type, and severity)
Time frame: Week 1, Week 4, Week 8, Week 12, Week 18
PK parameters of filgotinib and its primary metabolite GS-829845 including maximum observed plasma concentration at steady-state [Cmax,ss]
Time frame: Week 4, Week 12 and Week 18
PK parameters of filgotinib and its primary metabolite GS-829845 including area under the plasma concentration-time curve over the dosing interval at steady-state [AUC0-24,ss]
Time frame: Week 4, Week 12 and Week 18
PK parameters of filgotinib and its primary metabolite GS-829845 including area under the plasma concentration-time curve over the dosing interval at steady-state for the effective exposure [AUCeff,ss]
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Hôpital Bicêtre
Le Kremlin-Bicêtre, France
RECRUITINGCharité - Campus Virchow-Klinikum
Berlin, Germany
RECRUITINGHamburger Zentrum fuer Kinder und Jugendrheumatologie
Hamburg, Germany
RECRUITINGPecsi Tudomanyegyetem Klinikai Kozpont
Pécs, Hungary
RECRUITINGIstituto Giannina Gaslini-Ospedale Pediatrico IRCCS
Genova, Italy
RECRUITINGCentrum Medyczne Hipokrates S C Elzbieta I Grzegorz Grzesk
Bydgoszcz, Poland
RECRUITINGMICS Centrum Medyczne Torun
Torun, Poland
RECRUITINGETG JustMed
Warsaw, Poland
RECRUITING...and 4 more locations
Time frame: Week 4, Week 12 and Week 18
Acceptability of the age-appropriate pediatric formulation and the adult commercially developed film-coated tablet formulation assessed by Pediatric Oral Medicine Acceptability Questionnaire for Patients (POMAQ-P)
Time frame: Week 4 and Week 18