Phase III trial of Cimzia (certolizumab pegol) shows improvement in chronic plaque psoriasis- UCB/Dermira
UCB and Dermira announced topline results from CIMPASI-1, a Phase III, 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-1 trial, Cimzia demonstrated statistically significant improvements for both co-primary endpoints compared to placebo at both treatment doses. This is the second of three Phase III clinical trials evaluating Cimzia in this patient population. UCB and Dermira announced topline results from CIMPASI-2 in October 2016.
CIMPASI-1 had an identical trial design to CIMPASI-2. The co-primary endpoints evaluated in both trials 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. In the CIMPASI-1 trial, consistent with the results of the CIMPASI-2 trial, CIMZIA demonstrated statistically significant improvements from baseline to week 16 relative to placebo for both co-primary endpoints at both treatment doses.