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
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Intravenous secukinumab
University of Florida
Gainesville, Florida, United States
RECRUITINGAnn and Robert H Lurie Childs Hosp
Chicago, Illinois, United States
RECRUITINGLevine Childrens Hospital
Charlotte, North Carolina, United States
Maximum concentration on Day 1
Maximum concentration of secukinumab on Day 1
Time frame: Pre-infusion and end of infusion (EOI) at Day 1
Maximum concentration at steady-state (Cmax, ss)
Maximum concentration at steady-state.
Time frame: 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 (Cmin, ss)
Minimum concentration at steady-state
Time frame: 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 (AUCtau, ss)
Area under the concentration-time curve at steady-state during a dosing interval
Time frame: 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 (Cavg,ss)
Average concentration at steady-state
Time frame: 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
Number of participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Novartis Pharmaceuticals
CONTACT
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Univ Hosp Cleveland Medical Center
Cleveland, Ohio, United States
RECRUITINGLegacy Emanuel Research Hosp Portland
Portland, Oregon, United States
RECRUITINGTexas Arthritis Center
El Paso, Texas, United States
RECRUITINGNumber of participants with AEs and SAEs as a measure of safety and tolerability
Time frame: Up to Week 20
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
Time frame: Up to Week 20