AstraZeneca PLC (LSE:AZN)'s Ultomiris (ravulizumab) met the prespecified primary endpoint in the global I CAN Phase III trial, showing a significant reduction in proteinuria measured by 24‑hour urine protein creatinine ratio (UPCR) at week 34 in adults with immunoglobulin A nephropathy (IgAN) at risk of progression. The trial’s other primary endpoint — change in estimated glomerular filtration rate (eGFR) — will be assessed at week 106.
The study was randomised 1:1 to Ultomiris or placebo, with IV dosing over a 106‑week blinded period and the trial designed to enrol about 510 participants across 28 countries. AstraZeneca (LSE:AZN) said reductions in proteinuria were rapid, appearing "as early as week 10," and that the safety profile observed was consistent with the known profile of Ultomiris with no new safety concerns identified.
"Many people living with IgAN continue to progress to kidney failure... 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," Jonathan Barratt, MD, Mayer Professor of Renal Medicine and I CAN investigator, said.
AstraZeneca added it will seek accelerated approval in key markets and will present the data at a forthcoming medical meeting.
