Alexion, AstraZeneca Rare Disease, announced positive results from a prespecified interim analysis of the global Phase III I CAN trial. The data demonstrate that Ultomiris® (ravulizumab) achieved a statistically significant and clinically meaningful reduction in proteinuria (excess protein in the urine) compared to placebo at week 34. The trial evaluated adults living with immunoglobulin A nephropathy (IgAN) who are actively at risk of progressive kidney failure.
The primary endpoint of this interim analysis, measured by 24-hour urine protein creatinine ratio (UPCR), revealed that Ultomiris delivered a 46.6% reduction in proteinuria from baseline (95% Confidence Interval [CI]: 39.0%, 53.2%), compared to just a 5.6% reduction (95% CI: -4.9%, 15.0%) in the placebo arm. This represents a highly statistically significant placebo-adjusted treatment effect of 43.4%(95% CI: 33.5%, 51.8%; p<0.0001).
The therapeutic intervention showed exceptionally rapid kinetics, showing a 36.7% reduction in proteinuria by week 10 (compared to 8.5% for placebo) that was steadily sustained through week 34. Crucially, this therapeutic benefit remained consistent across all prespecified patient subgroups, regardless of diverse baseline clinical severities or demographic traits.
Jonathan Barratt, MD, Mayer Professor of Renal Medicine at the University of Leicester, UK, and an I CAN trial investigator, stated:
“For patients with IgAN, terminal complement activation is a key driver of inflammation and progressive loss of kidney function, which can frequently result in end-stage kidney disease. These interim results show that by targeting the terminal complement pathway, Ultomiris delivered a rapid and significant reduction in proteinuria supporting its potential as a disease-modifying treatment for people living with this devastating rare disease.”
Written by: Pragna Biswas
Graphics by: Pra Hazra
