Ultomiris (ravulizumab) met the primary interim endpoint in the I CAN Phase III trial, showing a statistically significant and clinically meaningful reduction in proteinuria at week 34 in adults with IgAN at risk of progression1234.
Rapid reduction in proteinuria observed as early as week 10, measured by 24-hour urine protein creatinine ratio (UPCR)12.
The trial is global, randomized, double-blind, placebo-controlled, enrolling ~510 adults from 28 countries, with treatment for 106 weeks; primary endpoint for eGFR at week 10612.
IgAN is a rare inflammatory kidney disease that can progress to end-stage kidney disease; safety profile consistent with known Ultomiris profile12.
AstraZeneca plans accelerated approval filings in key markets and full data presentation at a medical meeting24.
Sources:
1. https://www.investing.com/news/sec-filings/astrazeneca-reports-ultomiris-meets-primary-endpoint-in-igan-phase-iii-trial-93CH-4625530
2. https://www.stocktitan.net/sec-filings/AZN/6-k-astrazeneca-plc-current-report-foreign-issuer-443a22690872.html
3. https://firstwordpharma.com/story/7191465
4. https://insights.citeline.com/scrip/r-and-d/clinical-trials/astrazenecas-ultomiris-hits-interim-phase-iii-endpoint-in-igan-eyes-accelerated-filings-PYPAM2WS35BTHKUAMCTFJCBPXA/