Alexion Completes Enrollment in Phase IIb Trial of Eculizumab in Rheumatoid Arthritis Patients
Thursday January 30, 7:31 am ET
CHESHIRE, Conn., Jan. 30 /PRNewswire-FirstCall/ -- Alexion Pharmaceuticals Inc. (Nasdaq: ALXN - News) announced today that it has completed enrollment in its Phase IIb trial of eculizumab, a humanized monoclonal antibody C5 complement inhibitor, in rheumatoid arthritis patients. The trial is designed to assess the safety and efficacy of eculizumab and to confirm the drug's most efficacious dosing regimen. The trial enrolled approximately 350 patients at 69 centers in the U.S. and Canada who are being treated concomitantly with disease-modifying anti-rheumatic drugs. "Completing enrollment of this eculizumab Phase IIb rheumatoid arthritis trial is an important step in the development of eculizumab in this disease," stated Leonard Bell, M.D., Chief Executive Officer of Alexion. "In this larger patient study, we are treating patients for a six month period, and seek to confirm the promising clinical data obtained in our earlier eculizumab Phase IIa rheumatoid arthritis study. Importantly, we hope to obtain further information on the durability of response. Once the six month treatment period, all follow-up patient visits, and data collection are completed, we expect to analyze the data and report the results of this Phase IIb trial."
This double-blind, randomized, placebo-controlled Phase IIb trial has enrolled approximately 350 patients with mild to moderate disease undergoing treatment with moderate doses of methotrexate or leflunomide. The trial consists of three treatment arms. Patients are treated with placebo; eculizumab intravenous injection once per week for four weeks and then once every month; or eculizumab intravenous injection once per week for four weeks and then once every two weeks. The patients will be evaluated after a six month treatment period for safety and efficacy, and the primary efficacy endpoint will be improvement in the ACR20 score. |
