AB1089 Investigation of the efficacy and safety of secukinumab treatment in juvenile idiopathic arthritis subtypes of juvenile psoriatic and enthesitis-related arthritis: design of a randomised, double-blind, placebo controlled, multicenter study

Background Secukinumab (AIN457), a fully human anti-interleukin-17A monoclonal antibody, has demonstrated a significant clinically meaningful efficacy on signs and symptoms, structure and function in adults with ankylosing spondylitis (AS)1 and psoriatic arthritis (PsA)2, both approved indications. These data support the proposed study in children with enthesitis-related arthritis (ERA) and juvenile psoriatic arthritis (JPsA). Objectives This phase 3 study will investigate the efficacy and safety of secukinumab in children≥2 to Methods Eighty biologic-naive children with active ERA or JPsA (active:≥3 active joints and >1 site of enthesitis at baseline or documented by history) will enrol into treatment period 1 and receive weekly open label s.c. secukinumab 75 or 150 mg, based on their body weight ( Results The primary efficacy endpoint will be time to flare in treatment period 2. Key secondary endpoints include JIA Pedi ACR 30/50/70/90/100 response rate, total dactylitis and enthesitis counts at week 12. Safety and tolerability will be assessed throughout the study. Conclusions The efficacy of Secukinumab in the approved adult indications of PsA and AS support the current study design to evaluate the efficacy and safety of secukinumab treatment in children with active JPsA or ERA. The primary efficacy endpoint will be time to flare in treatment period 2. Key secondary endpoints include JIA Pedi ACR 30/50/70/90/100 response rate, total dactylitis and enthesitis counts at week 12. Safety and tolerability will be assessed throughout the study. References [1] Baeten D, et al. Lancet. 2013;382(9906):1705–13 [] 2McInnes IB, et al. Lancet. 2015;386(9999):1137–46 Acknowledgements This research was funded by Novartis Pharma AG, Basel, Switzerland Disclosure of Interest D. Foell Consultant for: Novartis Pharma GmbH, Speakers bureau: Novartis Pharma GmbH, J. Veit Employee of: Novartis Pharma GmbH, E. Ilsley Employee of: Novartis Pharma AG, K. Abrams Shareholder of: Novartis Pharmaceuticals Corporation, Employee of: Novartis Pharmaceuticals Corporation