The trial is being initiated as a result of a patient recruitment delay faced by Novel 3, one of two ongoing phase III studies of sargramostim in Crohn’s disease. Schering aims to achieve finalization of the phase III program as soon as possible.
Patient enrollment for Novel 4, the other pivotal phase III clinical trial of sargramostim in Crohn’s disease, recently completed enrollment of more than 240 patients ahead of schedule. Data from Novel 4 are expected to be available in 2006.
These trials are part of a comprehensive study called New Opportunities to Verify Evolving Logic in Crohn’s disease (NOVEL). This is a worldwide clinical trials program supported by Schering for the ongoing development of sargramostim as a potential new treatment for Crohn’s disease.
Schering currently anticipates making a submission for sargramostim in the indication of Crohn’s disease by the end of 2007 or beginning of 2008.