Juvenile Idiopathic Arthritis
Conditions
Brief summary
A Study to evaluate the pharmacokinetics, safety, and tolerability in paediatric population for treating juvenile idiopathic arthritis (JIA).
Interventions
DRUGFilgotinib
Film-coated mini-tablets administered orally once daily
Sponsors
Alfasigma S.p.A.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
8 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * 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 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 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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
France, Germany, Poland, Spain, United Kingdom
Contacts
STUDY_DIRECTORAlfasigma Study Director
Alfasigma S.p.A.
Outcome results
None listed