03.10.2016 08:23:30
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Dermira Says CIMZIA Phase 3 Trial Meets Co-primary Efficacy Endpoints
(RTTNews) - UCB and Dermira Inc. (DERM) announced topline results from CIMPASI-2, a Phase 3, multi-center, placebo-controlled clinical trial evaluating the efficacy and safety of CIMZIA (certolizumab pegol) in adult patients with moderate-to-severe chronic plaque psoriasis.
In the CIMPASI-2 trial, CIMZIA demonstrated statistically significant improvements for both co-primary endpoints compared to placebo at both treatment doses. The CIMPASI-2 trial results are from the first of three Phase 3 clinical trials to be reported evaluating CIMZIA in this patient population.
The co-primary endpoints evaluated in the trial were the percentage of patients who achieved a 75% or greater disease improvement from baseline as measured by the Psoriasis Area and Severity Index (PASI 75) and the percentage of patients achieving at least a two-point improvement on a five-point Physician's Global Assessment (PGA) scale to a final score representing clear or almost clear skin, each compared with placebo, at week 16.
"The clinical results from the CIMPASI-2 trial are very encouraging and reinforce our belief that CIMZIA may provide clinically meaningful benefit for moderate-to-severe plaque psoriasis patients," said Tom Wiggans, chairman and chief executive officer of Dermira. "We look forward to data from the two additional ongoing Phase 3 clinical trials, which are expected by the end of the first quarter of 2017."
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