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Novartis SJIA drug Phase III trial meets primary, secondary endpoints

Swiss drug maker Novartis' first Phase III, double-blind, randomized, placebo-controlled study of ACZ885 in patients suffering from systemic juvenile idiopathic arthritis (SJIA) met all primary and secondary endpoints.

ACZ885 is a fully human monoclonal antibody that inhibits IL-1 beta, which is an important part of the body’s immune system defenses

In the study, ACZ885 was generally well tolerated.

The primary endpoint was the proportion of patients achieving the adapted ACR Pediatric 30 criteria, demonstrating a 30% improvement from baseline at Day 15 in at least three of the six variables

Novartis Pharmaceuticals Division head David Epstein said these results are a positive development for patients suffering from this very severe auto-inflammatory condition.