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Merck Initiates Phase II/III Clinical Trial of SLE

Posted on: Thursday, 13 December 2007, 15:00 CST

Merck KGaA has reported that its Serono division and its partner ZymoGenetics have initiated a Phase II/III clinical trial of atacicept in lupus nephritis, a severe form of systemic lupus erythematosus.

The one-year (52-week), randomized, double-blind, placebo-controlled Phase II/III clinical trial will enroll approximately 200 patients and will be conducted at approximately 80 sites in North America, Europe, Latin America and Asia.

The objective of the study is to evaluate the efficacy and safety of atacicept in patients with active lupus nephritis who are also receiving immunosuppressive therapy with mycophenolate mofetil (MMF) and corticosteroids. To be eligible to enroll in the trial, patients must have active lupus nephritis at the time of screening. The primary endpoint of the trial is the improvement in patients' renal function from baseline to week 52.

The trial is being conducted under a special protocol assessment agreement with the FDA and is intended to support worldwide applications for marketing authorization.

Nicole Onetto, senior vice president and chief medical officer of ZymoGenetics, said: "Based on its mechanism of action and our early clinical data in lupus, we believe that atacicept has the potential to reduce disease symptoms and may help patients improve kidney function."

Source: Datamonitor

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