Dermira Completes Patient Enrollment for Third Cimzia Phase 3 Trial in Psoriasis Program
Dermira, Inc., completed its patient enrollment for the CIMPACT clinical trial of CIMZIA® (certolizumab pegol) in adult patients with moderate-to-severe chronic plaque psoriasis. The CIMPACT study is the third and final clinical trial of the CIMZIA Phase 3 development program in moderate-to-severe chronic plaque psoriasis to complete enrollment, following the completion of enrollment for the CIMPASI-2 Phase 3 trial in September 2015 and CIMPASI-1 Phase 3 trial in November 2015.
Based on completion of enrollment in all three Phase 3 trials of the psoriasis program, Dermira now expects to announce topline data for the trials by the end of the first quarter of 2017, following completion of the 48-week blinded treatment period in each of the trials. Previously, the company had expected to announce topline data in 2017.
As previously disclosed, Dermira expects that marketing applications for CIMZIA in adults with moderate-to-severe chronic plaque psoriasis in the US and EU will be based on the results of the primary endpoints at 12 or 16 weeks, as applicable, with additional data collected through week 48 to provide further support for dosing recommendations. While any marketing approval will be based on the overall results of the trials, the company expects that marketing approval for CIMZIA in moderate-to-severe chronic plaque psoriasis in the U.S. and EU will require that each of the CIMPASI trials (CIMPASI-1 and CIMPASI-2) demonstrates that CIMZIA produces a statistically significant improvement relative to placebo in each of its co-primary endpoints, which are the proportion of patients who achieve (1) a 75 percent improvement in disease severity, as measured by the Psoriasis Area and Severity Index (PASI 75), and (2) an improvement of at least two points to a final score representing clear or almost clear skin on a five-point Physician's Global Assessment scale (PGA), each as measured at week 16. In addition, the company expects that EU approval for CIMZIA in moderate-to-severe plaque psoriasis will require that the CIMPACT trial demonstrates that CIMZIA produces a statistically significant improvement relative to placebo and to etanercept (marketed as Enbrel®*) in PASI 75, as measured at week 12.
“I am very pleased with the completion of patient enrollment for CIMPACT, our third and final CIMZIA Phase 3 clinical trial in psoriasis, which, similar to our CIMPASI-1 and CIMPASI-2 CIMZIA Phase 3 trials, was achieved ahead of schedule,” stated Tom Wiggans, chairman and chief executive officer of Dermira. “We are excited about the continued collaboration with UCB and progress towards our goal of bringing this important potential therapy to the millions of patients with moderate-to-severe plaque psoriasis, an often debilitating skin disease.”
The Phase 3 clinical development program, which is led by Dermira in collaboration with UCB, 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 three studies that have enrolled a total of approximately 1,000 patients, including patients with and without prior treatment experience with biologic products.
The two CIMPASI studies (CIMPASI-1 and CIMPASI-2), each of which has completed enrollment of approximately 225 patients, 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. The third study, CIMPACT, which has now completed enrollment of approximately 540 patients, 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. A secondary objective of the CIMPACT trial is to compare the efficacy of certolizumab pegol to etanercept.
The primary endpoint in CIMPACT, the placebo- and active-controlled study, is PASI 75, compared with placebo, as measured at week 12. CIMPASI-1 and CIMPASI-2, the placebo-controlled studies, have co-primary endpoints comprising both PASI 75 and PGA, 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.