Plaque psoriasis: CIMZIA (certolizumab pegol) Phase 3 trial results

UCB and Dermira, Inc. have announced topline results from CIMPASI-2, a Phase 3, multi-center, placebo-controlled clinical trial evaluating the efficacy and safety of CIMZIA® (certolizumab pegol) in adult patients with moderate-to-severe chronic plaque psoriasis. In the CIMPASI-2 trial, CIMZIA demonstrated statistically significant improvements for both co-primary endpoints compared to placebo at both treatment doses. The CIMPASI-2 trial results are from the first of three Phase 3 clinical trials to be reported evaluating CIMZIA in this patient population.¹

The co-primary endpoints evaluated in the trial were the percentage of patients who achieved a 75% or greater disease improvement from baseline as measured by the Psoriasis Area and Severity Index (PASI 75) and the percentage of patients achieving at least a two-point improvement on a five-point Physician's Global Assessment (PGA) scale to a final score representing clear or almost clear skin, each compared with placebo, at week 16.¹

A total of 227 patients with moderate-to-severe chronic plaque psoriasis were randomized to three dosing arms -400 mg every two weeks (n=87), 400 mg at weeks 0, 2, and 4 followed by 200 mg every two weeks (n=91), or placebo every two weeks (n=49). At week 16, the response rate for patients who achieved a PASI 75 was 82.6% for patients receiving the 400 mg dose every two weeks and 81.4% for patients receiving the 200 mg dose every two weeks, compared to 11.6% for patients receiving placebo. The response rate for patients achieving at least a two-point improvement to a final score of clear or almost clear skin on the PGA scale at week 16 was 71.6% for the 400 mg dose-treated patients and 66.8% for the 200 mg dose-treated patients, compared to 2.0% for the patients receiving placebo. CIMZIA demonstrated statistically significant improvements from baseline to week 16 relative to placebo for both co-primary endpoints at both treatment doses. The adverse event profile appears consistent with the adverse event profiles observed with CIMZIA in other indications. ¹

"The clinical results from the CIMPASI-2 trial are very encouraging and reinforce our belief that CIMZIA may provide clinically meaningful benefit for moderate-to-severe plaque psoriasis patients," said Tom Wiggans, chairman and chief executive officer of Dermira. "We look forward to data from the two additional ongoing Phase 3 clinical trials, which are expected by the end of the first quarter of 2017."

"People living with psoriasis often face a heavy disease burden and may experience significant physical discomfort, including severe itching and pain. Psoriasis has historically been difficult to treat and there remains a high unmet need among these patients, who still need additional treatment alternatives. Our collaboration with Dermira aims to provide value to this important patient population and broaden access to CIMZIA, the only Fc-free, PEGylated anti-TNF," said Emmanuel Caeymaex, Head of Immunology Patient Value Unit, UCB.

CIMZIA is not currently approved for the treatment of psoriasis by any regulatory authority worldwide.

The data from this study will be submitted for presentation at an upcoming medical congress and to a peer-reviewed medical journal for publication.

About CIMZIA Phase 3 Program

The Phase 3 clinical development program, which is led by Dermira in collaboration with UCB Pharma S.A., is designed to evaluate the efficacy and safety of CIMZIA in the treatment of adult patients with moderate-to-severe chronic plaque psoriasis. It consists of three trials that have enrolled approximately 1,000 patients, including patients with and without prior treatment experience with biologic products. If results from the Phase 3 clinical trial program are positive, regulatory submissions in the United States (U.S.), Canada and European Union (EU) are expected.

Two of the studies, CIMPASI-1 and CIMPASI-2, are randomized, blinded, parallel group, placebo-controlled, multi-center trials designed to evaluate the efficacy and safety of CIMZIA in the treatment of patients with moderate-to-severe chronic plaque psoriasis. CIMPASI-1 and CIMPASI-2 enrolled 234 and 227 patients, respectively. A third study, CIMPACT, enrolled 559 patients and is a randomized, blinded, parallel group, placebo- and active-controlled, multi-center study designed to evaluate the efficacy and safety of CIMZIA in patients with moderate-to-severe chronic plaque psoriasis.

CIMPASI-1 and CIMPASI-2 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 PGA scale, each compared with placebo, at week 16. The primary endpoint in CIMPACT, the placebo- and active-controlled study, is the percentage of patients on CIMZIA achieving a PASI 75 response, compared with placebo, at week 12. A secondary objective of the CIMPACT trial is to compare the efficacy of CIMZIA to ENBREL®* (etanercept). Patients in each trial may receive blinded CIMZIA treatment for up to 48 weeks followed by an open-label treatment period of up to an additional 96 weeks.

Under the terms of the agreement announced in July 2014, Dermira obtained exclusive rights to develop CIMZIA in psoriasis in the U.S., Canada and the EU. Subject to regulatory approval of CIMZIA in psoriasis, Dermira is granted an exclusive commercial license to market CIMZIA to dermatologists in the U.S. and Canada.

CIMZIA® is a registered trademark of the UCB Group of Companies.
*ENBREL® (etanercept) is a registered trademark of Amgen Inc.