Positive interim findings from the prespecified analysis of the Phase III I CAN trial show that Ultomiris (ravulizumab) achieved its primary endpoint in adults with immunoglobulin A nephropathy (IgAN) at risk of disease progression.

 

The study demonstrated a statistically significant and clinically meaningful reduction in proteinuria, measured by 24-hour urine protein creatinine ratio (UPCR), at week 34. The trial’s primary endpoint of change in estimated glomerular filtration rate (eGFR) will be assessed at week 106.

 

IgAN is a rare, progressive kidney disease driven by abnormal IgA immune complexes that deposit in the kidneys, triggering complement system activation, chronic inflammation, and gradual loss of kidney function. Over time, this can lead to chronic kidney disease and end-stage kidney disease requiring dialysis or transplant.

 

The condition affects more than 560,000 people across the US, EU5, and Japan, with over 60 percent considered eligible for treatment.

 

Commenting on the findings, Jonathan Barratt, Mayer Professor of Renal Medicine, University of Leicester, United Kingdom, and I CAN trial investigator, said: “Many people living with IgAN continue to progress to kidney failure, ultimately requiring dialysis or a transplant – outcomes that can place profound burden on patients’ daily lives – despite advances in care. 

 

"The interim I CAN results demonstrate that blocking terminal complement activation, a central driver of kidney inflammation in IgAN, with Ultomiris may play a promising role in reducing proteinuria. We look forward to understanding the full clinical impact of Ultomiris in treating this disease following study completion at two years.”

 

Marc Dunoyer, Chief Executive Officer, Alexion, AstraZeneca Rare Disease, said: “These positive data demonstrate that C5 complement inhibition with Ultomiris results in a rapid and clinically meaningful reduction in proteinuria as early as week 10 and underscores its potential as a disease-modifying approach in IgAN. 

 

"We look forward to filing these data with regulatory authorities in key regions, while in parallel, advancing this Phase III trial towards completion.”