Study to Measure Filgotinib in the Blood of Children and Teenagers With Arthritis Taking Filgotinib (SCALESIA)

Juvenile Idiopathic Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06222034
• Other study ID #: GLPG0634-CL-131
• Secondary ID: 2023-505844-21-0
• Status: Recruiting
• Phase: Phase 1
• Start date: April 2024
• Est. completion date: August 2026

Study information

• Verified date: April 2024
• Source: Galapagos NV
• Contact: Galapagos Medical Information
• Phone: +3215342900
• Email: medicalinfo[@]glpg.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: August 2026
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 18 Years

Eligibility

Key Inclusion Criteria:

• 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.

Key Exclusion Criteria:

• Participant with persistent oligoarthritis.
• Participant with undifferentiated arthritis.
• Participant with any other any other rheumatic, inflammatory, or immunologic disease (e.g. inflammatory bowel disease, hypogammaglobulinemia, systemic lupus erythematosus, or uncontrolled uveitis).
• Active infection that is clinically significant, as per judgment of the investigator.
• Participant with a history of complicated herpes zoster infection (with multi-dermatomal, disseminated, ophthalmic, or central nervous system involvement).
• Currently on any therapy for chronic infection (such as pneumocystis, cytomegalovirus, herpes simplex, or atypical mycobacteria). Note: Other protocol defined Inclusion/ Exclusion criteria may apply.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Juvenile
• Juvenile Idiopathic Arthritis

Intervention

Drug:
• Filgotinib
Film-coated mini-tablets administered orally once daily
• Filgotinib
Commercially developed film-coated tablet administered orally once daily

Locations

Country	Name	City	State
France	CHU Amiens - Hopital Nord	Amiens Cedex 1
France	Bicêtre University Hospital, Pediatric Rheumatology	Le Kremlin Bicêtre
Germany	Children's university hospital Charité, Campus Virchow, SPZ	Berlin
Germany	Hamburger Zentrum fur Kinder und Jugendrheumatologie	Hamburg
Poland	Malopolskie Badania Kliniczne	Krakow
Spain	Hospital Universitari Vall d'Hebron	Barcelona
Spain	Hospital Universitari i Politecnic La Fe	Valencia
United Kingdom	Great Ormond Street Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
Galapagos NV

Countries where clinical trial is conducted

France,  Germany,  Poland,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum observed plasma concentration at steady state of filgotinib (Cmax,ss)		Pre-dose on Day 10, 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours post-dose on Day 10
Primary	Cmax,ss of GS-829845, major active metabolite		Pre-dose on Day 10, 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours post-dose on Day 10
Primary	Area under the plasma concentration-time curve over the dosing interval at steady state of filgotinib (AUC0-24,ss)		Pre-dose on Day 10, 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours post-dose on Day 10
Primary	AUC0-24,ss of GS-829845, major active metabolite		Pre-dose on Day 10, 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours post-dose on Day 10
Primary	Area under the plasma concentration time curve over the dosing interval at steady state or the effective exposure of filgotinib (AUCeff,ss)		Pre-dose on Day 10, 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours post-dose on Day 10
Primary	AUCeff,ss of GS-829845, major active metabolite		Pre-dose on Day 10, 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours post-dose on Day 10
Secondary	Number of participants with treatment-emergent adverse events (TEAEs), TEAEs of interest, serious TEAEs, and TEAEs leading to treatment discontinuation.		Baseline (Day 1) up to week 96
Secondary	Acceptability of the commercially developed film-coated tablets and of the minitablets as measured by the Pediatric Oral Medicine Acceptability Questionnaire for Patients (POMAQ-P).		Week 4 and week 12