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).

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age2-17
SponsorNovartis Pharmaceuticals

About this trial

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

Qualifiers

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).

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Secukinumab

Treatment groups

20 Participants
are divided into 1 treatment group

Sponsors and collaborators