A new publication of the investigational treatment for lupus, rontalizumab, showed encouraging safety results among patients with mild lupus in a Phase 1 study, the first phase of clinical testing. In development by Genentech, rontalizumab is a humanized monoclonal antibody that targets interferon-alpha, which means that it is designed to be similar to natural human antibodies so the body will not reject it as a foreign substance.
Based on the Phase 1 results, rontalizumab is now in the second phase of testing in a Phase II trial, called ROSE (Rontalizumab in Systemic Lupus Erythematosus). The randomized, double-blind, placebo-controlled multicenter study is studying the safety and effectiveness of rontalizumab in patients with moderate to severe systemic lupus erythematosus (SLE). The study will enroll approximately 210 patients at up to 100 sites in North America, Latin America, and Europe.