Measuring Filgotinib in Children and Teenagers with Arthritis
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
This study tests how well a medication called Filgotinib works and how safe it is for children and teenagers with Juvenile Idiopathic Arthritis who aren't getting enough relief from their current treatments.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 8 Years to 18 Years |
| Sex | All |
| Sponsor | Alfasigma S.p.A. Industry-sponsored |
| Drugs / interventions | methotrexate |
| Locations | 10 sites (Amiens and 9 other locations) |
| Trial ID | NCT06222034 on ClinicalTrials.gov |
What this trial studies
This study evaluates the pharmacokinetics, safety, and tolerability of Filgotinib in children and teenagers diagnosed with Juvenile Idiopathic Arthritis (JIA). It aims to determine how the drug behaves in the body and its effectiveness in managing the condition. Participants will be closely monitored to assess their response to the treatment and any potential side effects. The study is designed for those whose arthritis is not adequately controlled by their current therapy.
Who should consider this trial
Good fit: Ideal candidates are children and teenagers with a diagnosis of Juvenile Idiopathic Arthritis who have moderately to severely active disease not adequately controlled by current therapies.
Not a fit: Patients with mild or well-controlled Juvenile Idiopathic Arthritis may not receive benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new effective treatment option for children and teenagers suffering from Juvenile Idiopathic Arthritis.
How similar studies have performed: Other studies have shown promise in evaluating pharmacokinetics and safety of treatments for JIA, making this approach both relevant and potentially beneficial.
Eligibility criteria
Show full inclusion / exclusion 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/ Exclusion criteria may apply.
Where this trial is running
Amiens and 9 other locations
- CHU Amiens - Hopital Nord — Amiens, France (Recruiting)
- Bicêtre University Hospital — Le Kremlin-Bicêtre, France (Recruiting)
- Children's university hospital Charité, Campus Virchow, SPZ — Berlin, Germany (Recruiting)
- Hamburger Zentrum fur Kinder und Jugendrheumatologie — Hamburg, Germany (Recruiting)
- Asklepios Klinik Sankt Augustin GmbH — Sankt Augustin, Germany (Not_yet_recruiting)
- Malopolskie Badania Kliniczne — Krakow, Poland (Recruiting)
- Hospital Universitari Vall d'Hebron — Barcelona, Spain (Recruiting)
- Hospital Sant Joan de Deu — Barcelona, Spain (Recruiting)
- Hospital Universitari i Politecnic La Fe — Valencia, Spain (Recruiting)
- Great Ormond Street Hospital — London, United Kingdom (Not_yet_recruiting)
Study contacts
- Study coordinator: Pilar de la Torre
- Email: medicalinfo@alfasigma.com
- Phone: 00800 7878 1345
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.