Juvenile Psoriatic Arthritis
Conditions
Keywords
Pediatric, JPsA, Pharmacokinetic (PK), safety, Intravenous (i.v.), Secukinumab
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
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.
Interventions
BIOLOGICALSecukinumab
Intravenous secukinumab
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 17 Years
Healthy volunteers
No
Inclusion 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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum concentration on Day 1 | Pre-infusion and end of infusion (EOI) at Day 1 | Maximum concentration of secukinumab on Day 1 |
| Maximum concentration at steady-state (Cmax, ss) | Preinfusion and EOI on Day 1, Day 29 and Day 57; weekly on Day 64, Day 71, Day 78, and Day 85; on Day 141 (pre-infusion if participant continues to the optional extension treatment or anytime during the visit if does not continue); preinfusion on Day 365 | Maximum concentration at steady-state. |
| Minimum concentration at steady-state (Cmin, ss) | Preinfusion and EOI on Day 1, Day 29 and Day 57; weekly on Day 64, Day 71, Day 78, and Day 85; on Day 141 (pre-infusion if participant continues to the optional extension treatment or anytime during the visit if does not continue); preinfusion on Day 365 | Minimum concentration at steady-state |
| Area under the concentration-time curve at steady-state (AUCtau, ss) | Preinfusion and EOI on Day 1, Day 29 and Day 57; weekly on Day 64, Day 71, Day 78, and Day 85; on Day 141 (pre-infusion if participant continues to the optional extension treatment or anytime during the visit if does not continue); preinfusion on Day 365 | Area under the concentration-time curve at steady-state during a dosing interval |
| Average concentration at steady-state (Cavg,ss) | Preinfusion and EOI on Day 1, Day 29 and Day 57; weekly on Day 64, Day 71, Day 78, and Day 85; on Day 141 (pre-infusion if participant continues to the optional extension treatment or anytime during the visit if does not continue); preinfusion on Day 365 | Average concentration at steady-state |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) | Up to Week 20 | 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. | Up to Week 20 | Number of participants with clinically significant changes in clinical laboratory measures and vital signs as a measure of safety and tolerability |
Countries
United States
Contacts
CONTACTNovartis Pharmaceuticals
Outcome results
None listed