An Open-label, Multicenter Study to Evaluate Pharmacokinetics, Safety and Tolerability up to 6 Years of Intravenous Secukinumab Infusions in Pediatric Participants With Juvenile Psoriatic Arthritis
Novartis Pharmaceuticals
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
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
- Age range
- 2–17 years
- Sex
- All
- Healthy volunteers
- No
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 criter…
Interventions
- BiologicalSecukinumab
Intravenous secukinumab
Locations (7)
- University of FloridaGainesville, Florida
- Ann and Robert H Lurie Childs HospChicago, Illinois
- Levine Childrens HospitalCharlotte, North Carolina
- Cincinnati Childrens HospitalCincinnati, Ohio
- Univ Hosp Cleveland Medical CenterCleveland, Ohio
- Legacy Emanuel Research Hosp PortlandPortland, Oregon