Final trial phase begins for drug’s plaque-psoriasis indication

January 23, 2015

A phase 3 clinical program is under way to further evaluate the efficacy and safety of Cimzia (certolizumab pegol, UCB) in adult patients with moderate to severe chronic plaque psoriasis.

A phase 3 clinical program is under way to further evaluate the efficacy and safety of Cimzia (certolizumab pegol, UCB) in adult patients with moderate to severe chronic plaque psoriasis.

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Cimzia is currently FDA-approved for treating a range of conditions, including Crohn’s disease, rheumatoid arthritis and psoriatic arthritis. The phase 3 clinical development program is being led by Dermira, Menlo Park, Calif., in collaboration with Brussels, Belgium-based UCB, as part of an agreement announced last summer that gives Dermira exclusive rights to develop certolizumab pegol for psoriasis in the United States, Canada and the European Union. Cimzia is not currently approved for the treatment of psoriasis anywhere in the world.

The phase 3 trial will enroll about 1,000 psoriasis patients, some of whom have been treated with biologic products, some who have not. The first two studies evaluated certolizumab pegol’s efficacy and safety in treating plaque psoriasis. The third has a primary objective of comparing the drug’s efficacy and safety with placebo, with a secondary objective of comparing it with etanercept (Enbrel, Amgen). The primary endpoint is the percentage of patients on certolizumab pegol achieving 75 percent or greater disease improvement from baseline, compared with placebo, as measured by the Psoriasis Area and Severity Index (PASI 75) at week 12.

Top-line data are expected in 2017.