Dermira, UCB begin phase 3 program of Cimzia for plaque psoriasis

Dermira and UCB announced that the first patients have begun a phase 3 clinical program to study the efficacy and safety of Cimzia for the treatment of moderate-to-severe chronic plaque psoriasis.

Cimzia (certolizumab pegol) is a crystallizable fragment (Fc)-free, PEGylated anti-tumor necrosis factor (anti-TNF) that is approved in the U.S. for treating adults with moderate-to-severe rheumatoid arthritis, active psoriatic arthritis and active ankylosing spondylitis. It is also approved for reducing signs and symptoms of Crohn’s disease, according to a joint press release from the two companies. However, the drug is not currently approved for treating plaque psoriasis.

Dermira is leading the phase 3 program in collaboration with UCB, which will consist of three studies enrolling approximately 1,000 patients, including those without prior experience with biologic products, the release stated. CIMPASI-1 and CIMPASI-2 are randomized, parallel-group multicenter studies that are designed to measure efficacy and safety of certolizumab in patients with moderate-to-severe plaque psoriasis. The third study, CIMPACT, will compare efficacy and safety of certolizumab with placebo in treating moderate-to-severe chronic plaque psoriasis. The study’s secondary objective is to compare safety and efficacy of certolizumab with Enbrel (etanercept, Amgen).

The percentage of patients 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 is the primary endpoint for the CIMPACT study. PASI 75 and the percentage of patients achieving at least a two-point improvement representing clear or almost clear skin on a five-point Physician’s Global Assessment scale compared with placebo at week 16 are co-primary endpoints for the other two studies, according to the release.

In a phase 2 study, PASI 75 was achieved by 75%, 83% and 7% of patients in the certolizumab 200 mg, 400 mg and placebo groups, respectively (P< .001 for both treatment arms vs. placebo), according to the release. These results were used to support continued phase 3 development.

References: www.demira.com, www.ucb.com.