Data Show a Statistically Significant 87% Reduction in IgG4-RD Flares, With Primary and All Key Secondary Endpoints Met
First Randomized, Placebo-Controlled Trial to Demonstrate Benefit in IgG4-RD
THOUSAND OAKS, Calif., June 5, 2024 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced positive topline results from its randomized, double-blind, multicenter, placebo-controlled Phase 3 clinical trial (NCT04540497) evaluating the efficacy and safety of UPLIZNA® (inebilizumab-cdon) for the treatment of Immunoglobulin G4-related disease (IgG4-RD).
The trial met its primary endpoint, showing a statistically significant 87% reduction in the risk of IgG4-RD flare compared to placebo (Hazard Ratio 0.13, p