Phase 3 Trials Initiated for Potential Plaque Psoriasis Treatment

Earlier this month, Dermira Inc. and UCB announced the initiation of phase 3 clinical trials designed to evaluate the efficacy and safety of Cimzia (certolizumab pegol) in adult patients with moderate-to-severe chronic plaque psoriasis.

The clinical development program will consist of three studies and will enroll a total of approximately 1,000 patients, some of whom have previously been treated with biologics.

According to the news release from Dermira, two studies (CIMPASI-1 and CIMPASI-2) are randomized, blinded, parallel group, placebo-controlled, multi-center studies “designed to evaluate the efficacy and safety of certolizumab pegol in the treatment of patients with moderate-to-severe chronic plaque psoriasis.” The third study (CIMPACT) is a randomized, blinded, parallel group, placebo-controlled and blinded, active-controlled, multi-center study “with a primary objective of comparing the efficacy and safety of certolizumab pegol to placebo in the treatment of patients with moderate-to-severe chronic plaque psoriasis.”

The primary endpoint of CIMPACT will be “the percentage of patients on certolizumab pegol achieving 75% or greater disease improvement from baseline, compared with placebo, as measured by the Psoriasis Area and Severity Index (PASI 75) at week 12.” CIMPACT will also compare the efficacy and safety of certolizumab pegol to etanercept.

The primary endpoints of CIMPASI-1 and CIMPASI-2 will comprise “both PASI 75 and the percentage of patients achieving at least a two-point improvement to a final score representing clear or almost clear skin on a five-point Physician’s Global Assessment scale, each compared with placebo, at week 16.”

Patients in each trial may receive blinded treatment for up to 48 weeks and may also receive open-label treatment with certolizumab pegol for up to an additional 96 weeks. Top-line data from these studies are expected in 2017.