Patient Enrollment Completed for Second Phase III Clinical Trial in Psoriasis Program
Dermira, Inc., a specialty biopharmaceutical company, announced the completion of patient enrollment for the global CIMPASI-1 clinical trial of certolizumab pegol (Cimzia, UCB Inc.) in adult patients with moderate-to-severe chronic plaque psoriasis. The first clinical trial, CIMPASI-2, completed enrollment in September 2015, and the third and final trial in the clinical development program, CIMPACT, continues to enroll patients. Dermira expects to announce topline efficacy and safety data from the Phase III clinical development program in 2017, consistent with previous guidance, based on current patient enrollment projections for CIMPACT and following completion of the 48-week, blinded treatment period for all 3 trials.
The Phase III clinical development program is designed to evaluate the efficacy and safety of certolizumab pegol in the treatment of adult patients with moderate-to-severe chronic plaque psoriasis. It consists of 3 studies that aim to enroll a total of approximately 1,000 patients, including patients with and without prior treatment experience with biologic products.
Two of the studies, CIMPASI-1 and CIMPASI-2, are randomized, blinded, parallel group, placebo-controlled, multi-
center trials designed to evaluate the efficacy and safety of certolizumab pegol in the treatment of patients with moderate-to-severe chronic plaque psoriasis. Each has now completed enrollment of approximately 225 patients. The third study, CIMPACT, which is the largest of the 3 studies, will enroll approximately 540 patients and is a randomized, blinded, parallel-group, placebo-controlled and blinded, active-controlled, multicenter 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. A secondary objective of the CIMPACT trial is to compare the efficacy of certolizumab pegol to etanercept (Enbrel, Amgen Inc.).
The primary endpoint in CIMPACT, the placebo- and active-controlled study, is the percentage of patients on certolizumab pegol achieving 75% or greater disease improvement from baseline, compared with placebo, as measured by the PASI 75 at week 12. CIMPASI-1 and CIMPASI-2, the placebo-controlled studies, have co-primary endpoints comprising both PASI 75 and the percentage of patients achieving at least a 2-point improvement to a final score representing clear or almost clear skin on a 5-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. Patients in each study may receive open-label treatment with certolizumab pegol for up to an additional 96 weeks.