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 (9) 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
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