Dermira and UCB initiate Phase III programme for Cimzia in Plaque Psoriasis.

Dermira, Inc and UCB, announced that the first patients have been dosed in the Phase III clinical program designed to evaluate the efficacy and safety of Cimzia (certolizumab pegol) in adult patients with moderate-to-severe chronic plaque Psoriasis. Cimzia is not currently approved for the treatment of Psoriasis by any regulatory authority worldwide.

The Phase III clinical development program consists of three 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 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. A secondary objective of the study is to compare the efficacy and safety of certolizumab pegol to etanercept (Enbrel).

Dermira obtained exclusive rights to develop certolizumab pegol in Psoriasis in the United States, Canada and the European Union. Subject to regulatory approval of Cimzia in Psoriasis, Dermira is granted an exclusive commercial license to market Cimzia to dermatologists in the US and Canada.