A randomized, double-blind, parallel group phase III multi-center trial to compare twice daily topical application of M518101, Daivonex� and vehicle in patients with plaque psoriasis
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Last updated:17th Jul 2013
The trial is designed with two sequentially assessed primary objectives as described in the EMA guideline (Points to consider on switching between superiority and non-inferiority. EMA, July 2000). For the first stage, the primary objective is to demonstrate that M518101 is non-inferior to Daivonex� in % reduction in mPASI and success rate based on IGA. If non-inferiority is demonstrated, the analysis will proceed to the second stage, which is to demonstrate that M518101 is more effective than Daivonex� in the same endpoints. In addition, superiority to Vehicle for both M518101 and Daivonex� will be tested for the same endpoints.
|Study start date||2013-07-17|