Merck Serono and development partner ZymoGenetics have initiated a Phase II/III trial of atacicept in patients with systemic lupus erythematosus (SLE) to evaluate the efficacy and safety of the drug for the treatment of SLE.

The study is being conducted under a Special Protocol Assessment (SPA) 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 part of a potential registration package to support worldwide applications for marketing authorization.

The one-year, randomized, double-blind, placebo-controlled international trial will enroll approximately 500 patients with SLE. The trial will evaluate the efficacy and safety of atacicept compared to placebo in preventing SLE flares. The primary endpoint is the proportion of subjects experiencing a new disease flare, based on BILAG (British Isles Lupus Assessment Group) measurements, during the treatment period.

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