RecruitingPhase 1NCT06222034

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

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


Sponsor

Alfasigma S.p.A.

Enrollment

10 participants

Start Date

May 13, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 8 YearsMax Age: 18 Years

Inclusion Criteria10

  • 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.

Exclusion Criteria6

  • 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).

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Interventions

DRUGFilgotinib

Film-coated mini-tablets administered orally once daily

DRUGFilgotinib

Commercially developed film-coated tablet administered orally once daily


Locations(10)

CHU Amiens - Hopital Nord

Amiens, France

Bicêtre University Hospital

Le Kremlin-Bicêtre, France

Children's university hospital Charité, Campus Virchow, SPZ

Berlin, Germany

Hamburger Zentrum fur Kinder und Jugendrheumatologie

Hamburg, Germany

Asklepios Klinik Sankt Augustin GmbH

Sankt Augustin, Germany

Malopolskie Badania Kliniczne

Krakow, Poland

Hospital Universitari Vall d'Hebron

Barcelona, Spain

Hospital Sant Joan de Deu

Barcelona, Spain

Hospital Universitari i Politecnic La Fe

Valencia, Spain

Great Ormond Street Hospital

London, United Kingdom

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NCT06222034


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