Evaluating the safety and effectiveness of intravenous secukinumab in children with juvenile psoriatic arthritis.
An Open-label, Multicenter Study to Evaluate Pharmacokinetics, Safety and Tolerability up to 6 Years of Intravenous Secukinumab Infusions in Pediatric Participants With Juvenile Psoriatic Arthritis
This study is testing if an intravenous medication called secukinumab is safe and effective for children with juvenile psoriatic arthritis.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 2 Years to 17 Years |
| Sex | All |
| Sponsor | Novartis Industry-sponsored |
| Drugs / interventions | methotrexate, prednisone, secukinumab |
| Locations | 7 sites (Gainesville, Florida and 6 other locations) |
| Trial ID | NCT06751238 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the pharmacokinetics, safety, and tolerability of multiple doses of intravenous secukinumab in pediatric participants diagnosed with juvenile psoriatic arthritis (JPsA). It is a multicenter, open-label study that includes an optional treatment extension period lasting up to six years. Participants will be monitored for their response to the treatment and any adverse effects that may arise during the study period.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 2 to 17 years with a confirmed diagnosis of juvenile psoriatic arthritis and an inadequate response to previous treatments.
Not a fit: Patients who do not have a confirmed diagnosis of juvenile psoriatic arthritis or those who have not experienced inadequate responses to prior treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option for children suffering from juvenile psoriatic arthritis, potentially improving their quality of life.
How similar studies have performed: Other studies have shown promising results with secukinumab in treating various forms of arthritis, indicating potential success for this approach in pediatric patients.
Eligibility criteria
Show full inclusion / exclusion criteria
Key Inclusion Criteria: * Participants parent's or legal representative(s) written informed consent and child's assent, if appropriate, must be obtained before any study related activity or assessment is performed. Of note, if the participant reaches age of consent (as per local law) during the study, they will also need to sign the corresponding study ICF (Informed Consent Form). * Males and females ≥2 years old to \<18 years old at the time of screening. * Confirmed diagnosis of JPsA according to the modified International League of Associations for Rheumatology (ILAR) classification criteria that must have occurred at least 6 months prior to screening. * Active JPsA disease defined as ≥3 active joints (swollen or if not swollen must be both tender and limited range of motion) at baseline (BSL). * Inadequate response (≥1 month) or intolerance to ≥1 Non-Steroidal Anti-Inflammatory Drug (NSAID) at screening. * Inadequate response (≥2 months) or intolerance to ≥ 1 Disease Modifying Anti-Rheumatic Drug (DMARD) at screening. * Concomitant use of the following second-line agents such as disease-modifying and/or immunosuppressive drugs to treat the JPsA will be allowed: * Stable dose of methotrexate (MTX) (maximum of 20 mg/ m2 BSA/ week) for at least 4 weeks prior to the BSL visit, with folic/folinic acid supplementation (according to standard medical practice of the center). * Stable dose of an oral corticosteroid (CS) at a prednisone equivalent dose of \<0.2 mg/kg/day or up to 10 mg/day maximum, whichever is less, for at least 7 days prior to BSL. * Stable dose of no more than one NSAID for at least 1 week prior to BSL. Key Exclusion Criteria: * Participants with body weight less than 10 kg at screening. * Use of other investigational drugs within 4 weeks or 5 half-lives of BSL, or until the expected pharmacodynamic effect has returned to BSL, whichever is longer. * History of hypersensitivity to study drug or its excipients or to drugs of similar chemical classes. * Participants with active inflammatory bowel disease or active uveitis at screening or BSL. * Fulfilling diagnostic criteria for any International League of Associations for Rheumatology (ILAR ) juvenile idiopathic arthritis (JIA) category other than JPsA at BSL. * Participants treated with prohibited medication * Participants taking any non-biologic DMARD at screening except for MTX. * Any medical or psychiatric condition which, in the investigator's opinion, would preclude the participant from adhering to the protocol or completing the study per protocol. Other inclusion/exclusion criteria may apply
Where this trial is running
Gainesville, Florida and 6 other locations
- University of Florida — Gainesville, Florida, United States (Recruiting)
- Ann and Robert H Lurie Childs Hosp — Chicago, Illinois, United States (Recruiting)
- Levine Childrens Hospital — Charlotte, North Carolina, United States (Recruiting)
- Cincinnati Childrens Hospital — Cincinnati, Ohio, United States (Recruiting)
- Univ Hosp Cleveland Medical Center — Cleveland, Ohio, United States (Recruiting)
- Legacy Emanuel Research Hosp Portland — Portland, Oregon, United States (Recruiting)
- Texas Arthritis Center — El Paso, Texas, United States (Recruiting)
Study contacts
- Study coordinator: Novartis Pharmaceuticals
- Email: novartis.email@novartis.com
- Phone: 1-888-669-6682
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.