Study to Measure Filgotinib in the Blood of Children and Teenagers With Arthritis Taking Filgotinib (SCALESIA)
- Registration Number
- NCT06222034
- Lead Sponsor
- Alfasigma S.p.A.
- Brief Summary
A Study to evaluate the pharmacokinetics, safety, and tolerability in paediatric population for treating juvenile idiopathic arthritis (JIA).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 10
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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.
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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
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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.
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Female participants of childbearing potential (i.e. who have passed menarche) must have a negative highly sensitive urine pregnancy test.
Key
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Filgotinib Dose B Filgotinib Dose B of filgotinib tablet for participants with BW ≥25-\<60 kg Filgotinib Dose A Filgotinib Dose A of filgotinib mini-tablet for participants with bodyweight (BW) 15-\<25 kg Filgotinib Dose C Filgotinib Dose C of filgotinib tablet for participants with BW ≥60 kg
- Primary Outcome Measures
Name Time Method 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 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 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 Outcome Measures
Name Time Method 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 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
Trial Locations
- Locations (9)
CHU Amiens - Hopital Nord
🇫🇷Amiens Cedex 1, France
Children's university hospital Charité, Campus Virchow, SPZ
🇩🇪Berlin, Germany
Bicêtre University Hospital
🇫🇷Le Kremlin Bicêtre, France
Hamburger Zentrum fur Kinder und Jugendrheumatologie
🇩🇪Hamburg, Germany
Malopolskie Badania Kliniczne
🇵🇱Krakow, Poland
Hospital Universitari Vall d'Hebron
🇪🇸Barcelona, Spain
Great Ormond Street Hospital
🇬🇧London, United Kingdom
Hospital Sant Joan de Deu
🇪🇸Barcelona, Spain
Hospital Universitari i Politecnic La Fe
🇪🇸Valencia, Spain