A randomised, double blind, double dummy, active comparator and placebo controlled confirmative non-inferiority trial of FP187 compared to Fumaderm in moderate to severe plaque psoriasis
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Last updated:26th Jul 2013
To show non-inferiority of FP187 to Fumaderm� after 20 weeks of treatment with a 500 mg daily dose of FP187 (250 mg BID) against a 720 mg daily dose of Fumaderm� (240 mg TID) on two co-primary endpoints: - The proportion of patients achieving PASI75 with the predefined non-inferiority margin of 15 per cent points difference in PASI75. - The proportion of patients achieving a �clear� or �almost clear� score, or a 2 point improvement from baseline on sPGA. Both endpoints will be assessed after 20 weeks of treatment, and the non-inferiority margin for the proportions of patients achieving each endpoint will be 15 percentage points.
|Study start date||2013-07-26|