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
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).
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.
Single group
Secukinumab
Biological/VaccineIntravenous secukinumab
Maximum concentration on Day 1
Maximum concentration of secukinumab on Day 1
Maximum concentration at steady-state (Cmax, ss)
Maximum concentration at steady-state.
Minimum concentration at steady-state (Cmin, ss)
Minimum concentration at steady-state
Area under the concentration-time curve at steady-state (AUCtau, ss)
Area under the concentration-time curve at steady-state during a dosing interval
Number of participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Number of participants with AEs and SAEs as a measure of safety and tolerability
Number of participants with clinically significant changes in clinical laboratory measures and vital signs.
Number of participants with clinically significant changes in clinical laboratory measures and vital signs as a measure of safety and tolerability
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