Novartis has announced positive results in the first Phase III trial of ACZ885 (canakinumab) for patients with systematic juvenile idiopathic arthritis.
Novartis has announced positive results in the first Phase III trial of its drug ACZ885 (canakinumab) for patients with systematic juvenile idiopathic arthritis (SJIA). Canakinumab is a fully human monoclonal antibody that works by neutralizing interleukin-1-beta, a key cause of inflammation in SJIA, a rare but serious childhood auto-inflammatory disease.
The trial, which included 84 patients aged 2 to 19 with active SJIA, met all its primary and secondary end points. Over four weeks, participants received either a single subcutaneous dose of canakinumab (4 mg/kg up to a maximum of 300 mg) or placebo. Of those receiving canakinumab, 83.7% demonstrated at least 30% improvement from baseline to day 15 in at least three of six variables, compared with 9.8% of those receiving placebo. In addition, 32.6% of those receiving canakinumab achieved a 100% improvement in at least three of the six variables, compared with 0% of those receiving placebo.
The six variables being evaluated were: 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 lab measure of inflammation.
Results of a second Phase III trial, designed to determine whether canakinumab can extend the time between flares or eliminate the need for corticosteroids, will be presented later in the year. The company plans to submit the drug for regulatory approval in 2012. Canakinumab was approved by the FDA to treat cryopyrin-associated periodic syndrome in 2009.