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news.Trubion has announced that its collaboration partner, Pfizer, has initiated a phase 2 clinical trial of SBI-087 (PF-05230895) for the treatment of rheumatoid arthritis (RA). SBI-087 is a advanced, humanized small modular immunopharmaceutical (SMIP) protein therapeutic directed against the CD20 antigen. SBI-087 is also being evaluated in phase 1 clinical trials for RA and systemic lupus erythematosus (SLE).
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The study is a phase 2, multi-center, randomized, placebo-controlled, double-blind, parallel-group, outpatient dose regimen-finding study. It will enroll approximately 200 patients who meet the criteria for RA with American College of Rheumatology (ACR) Functional class I, II or III, are seropositive, and who have been diagnosed with RA more than six months before trial initiation.
Participants will be randomly assigned to receive either placebo or one of four SBI-087 dosing regimens. The study is designed to evaluate the safety and efficacy of a dose and dosage regimen of SBI-087 in seropositive patients with active RA, who are on a stable dose of methotrexate. The primary outcome measure will include responses based on the ACR criteria (ACR 20 response).
Scott Stromatt, senior vice president and chief medical officer of Trubion, said: “Initiating the Phase 2 trial of SBI-087 for RA is an important milestone for Trubion. We look forward to evaluation of our next-generation CD20 compound in a larger patient population and further definition of its role in helping Trubion to establish category leadership in autoimmune and inflammatory diseases.”