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AB Science SA Passes Futility Analysis in Pivotal Clinical Study in Mastocytosis


Monday, 11 Nov 2013 11:45am EST 

AB Science SA announced that the independent Data and Safety Monitoring Board (DSMB) created as part of the Company pivotal clinical study evaluating masitinib in the treatment of mastocytosis has recommended continuation of the study, based upon completion of the futility analysis included in the study protocol. The objective in this phase 3 study is to compare the safety and efficacy of masitinib to placebo in adult patients with Indolent Systemic Mastocytosis with severe handicap at baseline. The futility analysis was included in the clinical study design to ensure that the study could be stopped early if it appeared that the study would be eventually unable to demonstrate the efficacy of masitinib in the target population of patients with Indolent Systemic Mastocytosis with severe handicap at baseline. The analysis was performed with two-third of the target population to recruit. The futility analysis was performed by the independent Data and Safety Monitoring Board. It consisted in testing the possibility of masitinib to demonstrate superiority over placebo on the primary analysis set in the protocol, based on the EMA guideline on clinical trials in small populations. 

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