Evaluation of Intravenous Secukinumab Over 6 Years for Safety and Pharmacokinetics in Children With Juvenile Psoriatic Arthritis

What this Trial Is About

Researchers are studying intravenous secukinumab to understand its pharmacokinetics, safety, and tolerability in children with Juvenile Psoriatic Arthritis JPsA. This open-label, multicenter study includes pediatric patients aged 2 to under 18 years who have active JPsA with at least three active joints and have had an inadequate response or intolerance to certain standard treatments. The studys purpose is to gather information on how the medicine behaves in the body and how safe it is for long-term use over up to six years. Participants receive intravenous secukinumab as the study treatment. The study follows a single group design where all children receive this treatment. The treatment period includes multiple dosing visits with detailed assessments of the drug concentration in the body on specified days, including Day 1, Day 29, Day 57, several weekly visits thereafter, and extended follow-up visits up to one year. An optional extension period allows continued treatment and monitoring for up to six years. Throughout the study, participants undergo various evaluations including blood tests to measure drug levels and monitor safety. Researchers track adverse events and laboratory changes up to 20 weeks and assess pharmacokinetic measures such as maximum and minimum drug concentrations at steady state. The study involves regular visits for infusions and safety checks, with the total participation lasting up to six years if the participant continues into the extension phase. This long-term observation helps understand the treatments effects and safety over time.

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).