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

NCT06222034 | Recruiting Phase 1

• 2 other identifiers: GLPG0634-CL-1312023-505844-21-00
• Study Type: interventional
• Target: 10
• Locations: 5 countries
• Sites: 10

Brief Summary

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

Conditions

Juvenile Idiopathic Arthritis

Outcome Measures

Primary Outcomes (6)

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (2)

• 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

• 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

Study Arms (3)

Filgotinib Dose A

EXPERIMENTAL

Dose A of filgotinib mini-tablet for participants with bodyweight (BW) 15-\<25 kg

Drug: Filgotinib

Filgotinib Dose B

EXPERIMENTAL

Dose B of filgotinib tablet for participants with BW ≥25-\<60 kg

Drug: Filgotinib

Filgotinib Dose C

EXPERIMENTAL

Dose C of filgotinib tablet for participants with BW ≥60 kg

Drug: Filgotinib

Interventions

Filgotinib DRUG

Film-coated mini-tablets administered orally once daily

Also known as: GS-6034, GLPG0634

Filgotinib Dose A

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Alfasigma S.p.A.: lead

Study Sites (10)

CHU Amiens - Hopital Nord

Amiens, 80054, France

RECRUITING

Bicêtre University Hospital

Le Kremlin-Bicêtre, 94270, France

RECRUITING

Children's university hospital Charité, Campus Virchow, SPZ

Berlin, 13353, Germany

RECRUITING

Hamburger Zentrum fur Kinder und Jugendrheumatologie

Hamburg, 22081, Germany

RECRUITING

Asklepios Klinik Sankt Augustin GmbH

Sankt Augustin, 53757, Germany

NOT YET RECRUITING

Malopolskie Badania Kliniczne

Krakow, 30-002, Poland

RECRUITING

Hospital Universitari Vall d'Hebron

Barcelona, 08035, Spain

RECRUITING

Hospital Sant Joan de Deu

Barcelona, 08950, Spain

RECRUITING

Hospital Universitari i Politecnic La Fe

Valencia, 46026, Spain

RECRUITING

Great Ormond Street Hospital

London, WC1N 3JH, United Kingdom

NOT YET RECRUITING

MeSH Terms

Conditions

Arthritis, Juvenile

Interventions

GLPG0634

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Alfasigma Study Director

  Alfasigma S.p.A.

  STUDY DIRECTOR

Central Study Contacts

Pilar de la Torre

CONTACT

00800 7878 1345; medicalinfo@alfasigma.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2024
• First Posted: January 24, 2024
• Study Start: May 13, 2024
• Primary Completion: March 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: December 10, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

DE (3); FR (2); PL (1); ES (3); GB (1)