Dermira and UCB announce start of Phase 3 program for CIMZIA® (certolizumab pegol) in psoriasis

13-Jan-2015 - USA

Dermira, Inc. and UCB announced that the first patients have been dosed in the Phase 3 clinical program designed to evaluate the efficacy and safety of CIMZIA® (certolizumab pegol) in adult patients with moderate-to-severe chronic plaque psoriasis. This is an important step forward in the collaboration between Dermira and UCB in the development of solutions for patients with moderate-to-severe plaque psoriasis, a severe autoimmune disease. CIMZIA® is not currently approved for the treatment of psoriasis by any regulatory authority worldwide.

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 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 (marketed as ENBREL®).

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 Psoriasis Area and Severity Index (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 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, based on current enrollment projections, top-line data from these studies are expected in 2017. Patients in each study may receive open-label treatment with certolizumab pegol for up to an additional 96 weeks.

In a completed, 176-patient Phase 2 study, PASI 75 was achieved by 75% (44/59), 83% (48/58) and 7% (4/59) of patients in the certolizumab pegol 200 mg, 400 mg and placebo groups, respectively (p<0.001 for both treatment arms vs. placebo). These Phase 2 results support the continued Phase 3 clinical program for the development of certolizumab pegol in psoriasis.2

Under the terms of the agreement announced in July 2014, 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. The dosing of the first patient in the Phase 3 program has triggered a milestone payment of $7.3 million payable by UCB to Dermira in the first quarter of 2015.

https://www.bionity.com/en/news/151175/dermira-and-ucb-announce-start-of-phase-3-program-for-cimzia-certolizumab-pegol-in-psoriasis.html