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Clinical Trials in the USA / NCT06751238
Recruiting Phase 1

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).

NCT06751238 · tracked via the Priya Life Science USA tracker
Sponsor
Novartis Pharmaceuticals
Phase
Phase 1
Started
2025-09-24
Last updated
2026-09-09

Condition(s) studied

Juvenile Psoriatic Arthritis

Investigational drug(s) / intervention(s)

Secukinumab

Secukinumab: Intravenous secukinumab

Study 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

Sex
ALL
Min age
2 Years
Max age
17 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (11)

FacilityCityRegionStatus
Loma Linda University Health Loma Linda California Recruiting
University of Florida Gainesville Florida Recruiting
Ann and Robert H Lurie Childs Hosp Chicago Illinois Recruiting
Col Uni Med Center New York Presby New York New York Recruiting
Levine Childrens Hospital Charlotte North Carolina Recruiting
Cincinnati Childrens Hospital Cincinnati Ohio Recruiting
Univ Hosp Cleveland Medical Center Cleveland Ohio Recruiting
Legacy Emanuel Research Hosp Portland Portland Oregon Recruiting
Childrens Hosp Pittsburgh UPMC Pittsburgh Pennsylvania Recruiting
Texas Arthritis Center El Paso Texas Recruiting
University of Utah Salt Lake City Utah Recruiting

On this site

📄 Cosentyx (secukinumab) drug profile →

More Novartis Pharmaceuticals trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06751238 on ClinicalTrials.gov ↗ ← All trials in the USA