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

Status: Recruiting
Location: See all (10) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

A Study to evaluate the pharmacokinetics, safety, and tolerability in paediatric population for treating juvenile idiopathic arthritis (JIA).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 8
Maximum Age: 18
Healthy Volunteers: f
View:

• Participant with a body mass index (BMI) within the 5th to 95th percentiles for the age and gender (based on World Health Organization BMI charts). Participant must have a minimum weight of 15 kg.

• Participant must meet the International League of Associations for Rheumatology classification for 1 of the following categories and have, according to the investigator's judgment, moderately to severely active disease that is not adequately controlled with his/her current therapy.

‣ Rheumatoid factor (RF)-positive polyarthritis

⁃ RF-negative polyarthritis

⁃ Oligoarthritis

⁃ Psoriatic arthritis

⁃ Enthesis-related arthritis (ERA) Note: Historical Human leukocyte antigen B-27 (HLA-B27) results are considered appropriate for ERA diagnosis during screening.

⁃ Systemic JIA with active arthritis without active systemic features, or with active systemic features that are stable in the prior 6 months of time of enrollment

• Participant with intolerance or a history of inadequate response to at least one of the following medications for the treatment of JIA, administered for at least 12 weeks, based on current treatment guidelines: conventional synthetic disease-modifying antirheumatic drugs and biological disease-modifying antirheumatic drugs (including methotrexate) and non-steroidal anti-inflammatory drugs for ERA and psoriatic arthritis.

• Female participants of childbearing potential (i.e. who have passed menarche) must have a negative highly sensitive urine pregnancy test.

Locations
Other Locations
France
CHU Amiens - Hopital Nord
RECRUITING
Amiens
Bicêtre University Hospital
RECRUITING
Le Kremlin-bicêtre
Germany
Children's university hospital Charité, Campus Virchow, SPZ
RECRUITING
Berlin
Hamburger Zentrum fur Kinder und Jugendrheumatologie
RECRUITING
Hamburg
Asklepios Klinik Sankt Augustin GmbH
NOT_YET_RECRUITING
Sankt Augustin
Poland
Malopolskie Badania Kliniczne
RECRUITING
Krakow
Spain
Hospital Sant Joan de Deu
RECRUITING
Barcelona
Hospital Universitari Vall d'Hebron
RECRUITING
Barcelona
Hospital Universitari i Politecnic La Fe
RECRUITING
Valencia
United Kingdom
Great Ormond Street Hospital
NOT_YET_RECRUITING
London
Contact Information
Primary
Pilar de la Torre
medicalinfo@alfasigma.com
00800 7878 1345
Time Frame
Start Date: 2024-05-13
Estimated Completion Date: 2026-08
Participants
Target number of participants: 10
Treatments
Experimental: Filgotinib Dose A
Dose A of filgotinib mini-tablet for participants with bodyweight (BW) 15-\<25 kg
Experimental: Filgotinib Dose B
Dose B of filgotinib tablet for participants with BW ≥25-\<60 kg
Experimental: Filgotinib Dose C
Dose C of filgotinib tablet for participants with BW ≥60 kg
Sponsors
Leads: Alfasigma S.p.A.

This content was sourced from clinicaltrials.gov