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NCT06751238PHASE1Recruiting

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).

Novartis Pharmaceuticals

Start Date

9/24/2025

Completion Date

12/1/2032

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

Detailed Description

This is a multicenter, open-label study with an optional treatment extension period to evaluate pharmacokinetics, safety and tolerability (up to 6 years) of i.v. secukinumab in pediatric patients with JPsA.

Eligibility Criteria

Age Range: 2 years to 17 years

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

Interventions

BIOLOGICAL

Secukinumab

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Conditions

Juvenile Psoriatic Arthritis

Locations

University of Florida

Gainesville, Florida 32610 8068

United States

Ann and Robert H Lurie Childs Hosp

Chicago, Illinois 60611

United States

Levine Childrens Hospital

Charlotte, North Carolina 28203

United States

Cincinnati Childrens Hospital

Cincinnati, Ohio 45229

United States

Univ Hosp Cleveland Medical Center

Cleveland, Ohio 44106-5028

United States

Legacy Emanuel Research Hosp Portland

Portland, Oregon 97232

United States

Childrens Hosp Pittsburgh UPMC

Pittsburgh, Pennsylvania 15224

United States

Texas Arthritis Center

El Paso, Texas 79902

United States