Status:
RECRUITING
Study to Measure Filgotinib in the Blood of Children and Teenagers With Arthritis Taking Filgotinib (SCALESIA)
Lead Sponsor:
Alfasigma S.p.A.
Conditions:
Juvenile Idiopathic Arthritis
Eligibility:
All Genders
8-18 years
Phase:
PHASE1
Brief Summary
A Study to evaluate the pharmacokinetics, safety, and tolerability in paediatric population for treating juvenile idiopathic arthritis (JIA).
Eligibility Criteria
Inclusion
- Key
- 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
- 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.
Key Trial Info
Start Date :
May 13 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2026
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT06222034
Start Date
May 13 2024
End Date
August 1 2026
Last Update
December 10 2025
Active Locations (10)
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1
CHU Amiens - Hopital Nord
Amiens, France, 80054
2
Bicêtre University Hospital
Le Kremlin-Bicêtre, France, 94270
3
Children's university hospital Charité, Campus Virchow, SPZ
Berlin, Germany, 13353
4
Hamburger Zentrum fur Kinder und Jugendrheumatologie
Hamburg, Germany, 22081