Abstract: FR-PO0802
Prespecified Analysis of Expanded Safety Outcomes of Ravulizumab in IgAN from the SANCTUARY Trial
Session Information
- Glomerular Clinical Trials: From Data to Impact
November 07, 2025 | Location: Exhibit Hall, Convention Center
Abstract Time: 10:00 AM - 12:00 PM
Category: Glomerular Diseases
- 1402 Glomerular Diseases: Clinical, Outcomes, and Therapeutics
Authors
- Fenoglio, Roberta, Department of Clinical and Biological Sciences of the University of Turin, Turin, Italy
- Yee, Min, Global Patient Safety, Alexion, AstraZeneca Rare Disease, Boston, Massachusetts, United States
- Chen, I-Ru, China Medical University Hospital, Taichung City, Taiwan
- Philibert, David, Division of Nephrology, Department of Medicine, Université Laval, Québec City, Quebec, Canada
- Kaufeld, Jessica Katharina, Hannover Medical School, Department of Nephrology and Hypertension, Hannover, Germany
- Kim, Sung Gyun, Department of Internal Medicine, Hallym University Sacred Heart Hospital, Anyang, Korea (the Republic of)
- Williams, Cory, Clinical Development, Alexion, AstraZeneca Rare Disease, New Haven, Connecticut, United States
- Rice, Kara, Biostatistics, Alexion, AstraZeneca Rare Disease, Boston, Massachusetts, United States
- Kateifides, Andreas, Clinical Development, Alexion, AstraZeneca Rare Disease, Boston, Massachusetts, United States
- Farag, Youssef MK, Clinical Development, Alexion, AstraZeneca Rare Disease, Boston, Massachusetts, United States
- Barratt, Jonathan, Department of Cardiovascular Sciences, University of Leicester, Leicester, United Kingdom
- Lafayette, Richard A., Stanford Glomerular Disease Center, Stanford University Medical Center, Stanford, California, United States
Background
Ravulizumab (RAV), a complement C5 inhibitor, demonstrated clinically meaningful proteinuria reduction in the phase 2 SANCTUARY trial in IgA nephropathy (IgAN).1 Here, we report findings from a prespecified expanded safety analysis.
Methods
The phase 2, double-blind, randomized, placebo-controlled trial of RAV (IV q8w) in adults with IgAN (NCT04564339) included a 26-week randomized period (RAV [n=43]; placebo [PBO; n=23]). All patients then received open-label RAV during a 24-week extension period. Patients were required to be vaccinated against meningococcal infection.
Results
In the randomized period, most adverse events (AEs) were mild (90.6%; 87/96) with RAV, similar to PBO (89.3%; 67/75) (Table). There were no AEs leading to withdrawal of study drug, meningococcal infections, or deaths. The majority of AEs (86.5%; 83/96) in the randomized period were assessed as unrelated to RAV. One serious AE occurred in the RAV arm, hospitalization due to COVID-19, assessed as unrelated to intervention. Overall, the incidence of infections was similar in the RAV and PBO arms (46.5% vs 43.5% of patients). The most common infections in the RAV arm were nasopharyngitis and COVID-19 (occurring in 11.6% and 9.3%, respectively), while the most common infections in the PBO arm were influenza (8.7%) and nasopharyngitis (4.3%). There was a low incidence of infusion-related reactions, 4.7% with RAV and 8.7% with PBO, and no cases of clinically relevant immunogenicity. Safety data in the extension period were similar to the randomized period.
Conclusion
RAV was well-tolerated in patients with IgAN; no unexpected safety signals were observed. The safety data are consistent with the established RAV safety profile based on >37,000 patient-years of experience including four approved indications.
1. Lafayette R, et al. J Am Soc Nephrol. 2025;36(4):645–656.
Funding
- Commercial Support – Alexion, AstraZeneca Rare Disease, Boston, MA, United States