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news.ZymoGenetics and Serono have reported the start of a trial in which atacicept therapy will be evaluated in patients with rheumatoid arthritis, as part of a broad phase II clinical trial program.
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The study will investigate the efficacy of atacicept in patients with an inadequate response to prior treatment with TNF inhibitors. The efficacy of atacicept will be evaluated according to the American College of Rheumatology (ACR) criteria for defining clinical improvement in rheumatoid arthritis patients.
Patients will be randomized into groups receiving one of three dose levels of atacicept or placebo, in addition to background methotrexate therapy, and they will be treated for twenty-five weeks.
The primary endpoint will be the rate of ACR 20 response at week 26. Secondary objectives include further characterizing the efficacy, safety, tolerability and pharmacologic profile of atacicept at each of these dose levels.
ZymoGenetics and Serono are also in dialogue with the FDA regarding a phase II trial of atacicept for lupus. The companies are planning to initiate this trial in in mid-2007. Earlier this year, the companies completed phase Ib studies with atacicept in lupus and rheumatoid arthritis.