IDSMB gives go ahead for Actelion IPS trial

Swiss firm Actelion says that the Independent Data and Safety Monitoring Board has recommended the continuation of the pivotal Phase III BUILD-3  study, evaluating the efficacy and safety of Tracleer (bosentan) in  patients suffering from idiopathic pulmonary fibrosis.

The IDSMB was mandated to perform an efficacy and futility interim  analysis of 75% of events in BUILD-3 to assess whether study  continuation is warranted based on the primary objective of  demonstrating delayed disease worsening or death. Final study results  are expected before the end of the year.

BUILD-3 is a multicenter, double-blind, randomized, placebo-controlled,  parallel-group, event-driven morbidity/ mortality study evaluating the  safety and efficacy of bosentan 125mg in IPF patients. Trial enrollment  was completed in November 2008 with 616 patients. The study is  randomized with two bosentan subjects to one placebo and is planned to  reach 202 events.