NCT06751238 Study to Evaluate the Pharmacokinetics (PK), Safety and Tolerability up to 6 Years of Intravenous (i.v.) Secukinumab in Pediatric Participants With Juvenile Psoriatic Arthritis (JPsA).
| NCT ID | NCT06751238 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Novartis Pharmaceuticals |
| Condition | Juvenile Psoriatic Arthritis |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2025-09-24 |
| Primary Completion | 2029-10-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 20 participants in total. It began in 2025-09-24 with a primary completion date of 2029-10-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this study is to determine the PK, safety and tolerability of multiple doses of intravenous (i.v.) secukinumab in pediatric participants with JPsA
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06751238 clinical trial?
This trial is open to participants of all sexes, aged 2 Years or older, up to 17 Years, studying Juvenile Psoriatic Arthritis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06751238 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06751238 currently recruiting?
Yes, NCT06751238 is actively recruiting participants. Contact the research team at novartis.email@novartis.com for enrollment information.
Where is the NCT06751238 trial being conducted?
This trial is being conducted at Loma Linda, United States, Gainesville, United States, Chicago, United States, New York, United States and 7 additional locations.
Who is sponsoring the NCT06751238 clinical trial?
NCT06751238 is sponsored by Novartis Pharmaceuticals. The trial plans to enroll 20 participants.