Date: 2016-10-03
Type of information: Results
phase: 3
Announcement: results
Company: UCB (Belgium)
Product: Cimzia® (certolizumab pegol)
Action
mechanism: monoclonal antibody. Certolizumab is a recombinant Fab' antibody fragment against tumor necrosis factor alpha (TNF alpha) which is conjugated to polyethylene glycol pegol.
Disease: moderate-to-severe chronic plaque psoriasis
Therapeutic area: Autoimmune diseases - Dermatological diseases
Country: Austria, Canada, Poland, USA
Trial
details: The purpose of this phase 3 multicenter, double blind, parallel group study is to investigate the efficacy and safety of two dose levels of certolizumab pegol in adults with moderate to severe chronic plaque psoriasis. (NCT02326272)
Latest
news: * On October 3, 2016, UCB and Dermira 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.
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. The data from this study will be submitted for presentation at an upcoming medical congress and to a peer-reviewed medical journal for publication.
