Enrollment and Demographics, Challenges in Conducting Trials, and Study Results

Sometimes, we learn more from what isn’t achieved than when we achieve an expected result. Such is the case for our next guest, Dr. David R. Jayne, who is the first author of Clinical and Biomarker Responses to BI 655064, an Antagonistic Anti-CD40 Antibody, in Patients With Active Lupus Nephritis: A Randomized, Double-Blind, Placebo-Controlled, Phase II Trial , a study designed to characterize a dose-response relationship between an anti-CD40 monoclonal antibody known as Bi 655064 and complete renal response (CRR) in patients with active lupus nephritis (LN). Dr. Jayne and his research team’s study may not have shown this dose-response relationship, but what was gained along the way surely shows the power of the negative study!