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

Last updated: March 4, 2025
Sponsor: Alfasigma S.p.A.
Overall Status: Active - Recruiting

Phase

1

Condition

Joint Injuries

Rheumatoid Arthritis (Pediatric)

Arthritis And Arthritic Pain (Pediatric)

Treatment

Filgotinib

Clinical Study ID

NCT06222034
GLPG0634-CL-131
2023-505844-21-00
2023-505844-21
  • Ages 8-18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

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

  • Participant must meet the International League of Associations for Rheumatologyclassification for 1 of the following categories and have, according to theinvestigator's judgment, moderately to severely active disease that is notadequately 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 duringscreening.

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

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

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

Exclusion

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 lupuserythematosus, or uncontrolled uveitis).

  • Active infection that is clinically significant, as per judgment of theinvestigator.

  • Participant with a history of complicated herpes zoster infection (withmulti-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.

Study Design

Total Participants: 10
Treatment Group(s): 1
Primary Treatment: Filgotinib
Phase: 1
Study Start date:
May 13, 2024
Estimated Completion Date:
August 31, 2026

Connect with a study center

  • CHU Amiens - Hopital Nord

    Amiens Cedex 1, 80054
    France

    Active - Recruiting

  • Bicêtre University Hospital

    Le Kremlin Bicêtre, 94270
    France

    Active - Recruiting

  • Bicêtre University Hospital, Pediatric Rheumatology

    Le Kremlin Bicêtre, 94270
    France

    Active - Recruiting

  • Children's university hospital Charité, Campus Virchow, SPZ

    Berlin, 13353
    Germany

    Active - Recruiting

  • Hamburger Zentrum fur Kinder und Jugendrheumatologie

    Hamburg, 22081
    Germany

    Active - Recruiting

  • Malopolskie Badania Kliniczne

    Krakow, 30-002
    Poland

    Active - Recruiting

  • Hospital Sant Joan de Deu

    Barcelona, 08950
    Spain

    Active - Recruiting

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035
    Spain

    Active - Recruiting

  • Hospital Universitari i Politecnic La Fe

    Valencia, 46026
    Spain

    Active - Recruiting

  • Great Ormond Street Hospital

    London, WC1N 3JH
    United Kingdom

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.