Date: 2011-09-16
Type of information:
phase: 3
Announcement: results
Company: Novartis (Switzerland)
Product: ACZ885 (canakinumab)
Action mechanism: This fully human monoclonal antibody inhibits IL-1 beta, which is an important part of the body\\\'s immune system defenses. Excessive production of IL-1 beta plays a major role in certain inflammatory diseases, including SJIA. ACZ885 works by neutralizing IL-1 beta for a sustained period of time, therefore inhibiting inflammation.
Disease: systemic juvenile idiopathic arthritis (SJIA)
Therapeutic area: Autoimmune diseases - Rare diseases
Country:
Trial
details: The study was a Phase III, 4-week, randomized, double-blind, placebo-controlled study involving 84 patients between the ages of 2 and 19 years, with active SJIA. Patients were treated with either a single subcutaneous (s.c.) dose of ACZ885 (4 mg/kg, up to 300 mg) or placebo.
The primary endpoint was the proportion of patients achieving the adapted ACR Pediatric 30 criteria, demonstrating a 30% improvement in at least three of the six variables, from baseline at Day 15. The six variables included physician's assessment of disease activity, parent's or patient's assessment of overall well-being, functional ability, number of joints with active arthritis, number of joints with limitation of motion and C-reactive protein, a laboratory measure of inflammation.
Secondary endpoints included the proportion of patients achieving the adapted ACR Pediatric 50, 70, 90 and 100 criteria, demonstrating a 50%, 70%, 90% and 100% improvement in at least three variables from baseline at Day 15 and 29.
Latest
news: Novartis announced positive results of the first pivotal Phase III trial of ACZ885 (canakinumab) in patients with systemic juvenile idiopathic arthritis (SJIA), a rare and serious childhood auto-inflammatory disease. The results, presented at the 2011 European Pediatric Rheumatology Congress in Bruges, Belgium, showed all primary and secondary endpoints of the study were met. Most ACZ885 patients (83.7%) experienced at least a 30% improvement in symptoms vs. 9.8% for placebo (p<0.0001) and a third of ACZ885 patients (32.6%) achieved a 100% improvement vs. 0% for placebo (p=0.0001).
The results of a second pivotal Phase III trial, aimed at determining whether ACZ885 can extend the time to next flare and reduce or eliminate corticosteroid use, will be presented later this year. Worldwide regulatory submissions for ACZ885 in SJIA are planned for 2012.
