The one-year (52-week), randomized, double-blind, placebo-controlled international Phase II/III clinical trial will enroll approximately 500 patients with systemic lupus erythematosus (SLE).
The trial will evaluate the efficacy and safety of atacicept compared to placebo in preventing SLE flares. The primary efficacy endpoint is the proportion of subjects experiencing a new disease flare, based on BILAG1 measurements, during the 52-week treatment period.
The study is being conducted under a special protocol assessment agreement with the FDA. A second Phase II/III study in lupus nephritis, a severe form of SLE in which the kidneys are affected, was initiated in December 2007. These two studies are intended to form part of a potential registration package to support worldwide applications for marketing authorization.
Anton Hoos, Merck Serono’s head of global development, said: “Atacicept has the potential to alter the course of SLE, a complex and devastating disease.This study should provide us with a basis for assessing treatment outcomes with atacicept.”