Abstract: SA-OR086
Sibeprenlimab for the Treatment of IgAN: VISIONARY Phase 3 Interim and Prespecified Subgroup Analyses
Session Information
- High-Impact Clinical Trials - 2
November 08, 2025 | Location: Hall A, Convention Center
Abstract Time: 11:30 AM - 11:45 AM
Category: Glomerular Diseases
- 1402 Glomerular Diseases: Clinical, Outcomes, and Therapeutics
Authors
- Perkovic, Vlado, University of New South Wales, Sydney, New South Wales, Australia
- Barratt, Jonathan, University of Leicester, Leicester, England, United Kingdom
- Lafayette, Richard A., Stanford Medicine, Stanford, California, United States
- Liew, Adrian, The Kidney and Transplant Practice, Singapore, Singapore
- Suzuki, Yusuke, Juntendo University Faculty of Medicine, Tokyo, Japan
- Carroll, Kevin, KJC Statistics, Ltd, Cheadle, United Kingdom
- Cheung, Chee Kay, University of Leicester, Leicester, England, United Kingdom
- Tesar, Vladimir, Univerzita Karlova, Prague, Czechia
- Trimarchi, Hernan, Hospital Britanico de Buenos Aires, Buenos Aires, Argentina
- Wong, Muh Geot, Concord Repatriation General Hospital, Concord, New South Wales, Australia
- Zhang, Hong, Peking University First Hospital Department of Nephrology, Beijing, China
- Xia, Jing, Otsuka Pharmaceutical Development & Commercialization, Inc., Princeton, New Jersey, United States
- Fajardo, Cecile, Otsuka Pharmaceutical Development & Commercialization, Inc., Princeton, New Jersey, United States
- Shah, Lokesh N., Otsuka Pharmaceutical Development & Commercialization, Inc., Princeton, New Jersey, United States
- Hafkin, Jeffrey, Otsuka Pharmaceutical Development & Commercialization, Inc., Princeton, New Jersey, United States
- Rizk, Dana V., The University of Alabama at Birmingham Heersink School of Medicine, Birmingham, Alabama, United States
Background
In a prespecified interim analysis of VISIONARY, sibeprenlimab led to a 51.2% (P<0.0001) placebo (PBO)-adjusted reduction in uPCR-24h at 9 mos. We report on uPCR-24h, disease activity, and biomarkers through 12 mos of treatment and across prespecified subgroups.
Methods
VISIONARY, a phase 3 double-blind, PBO-controlled trial (NCT05248646), randomized adults with IgAN on supportive therapy 1:1 to SC sibeprenlimab 400 mg or PBO Q4W. uPCR-24h reduction and remission, hematuria, serum immunoglobulins, APRIL, Gd-IgA1, and safety were assessed for up to 12 mos. uPCR-24h responses were assessed across subgroups (demographics, screening uPCR-24h, eGFR, SGLT2i use, and prior immunosuppression).
Results
Greater reductions in uPCR-24h (54.3% PBO-adjusted) and spot uPCR were observed at 12 mos with sibeprenlimab vs PBO. Sibeprenlimab substantially reduced serum immunoglobulins, Gd-IgA1, APRIL, and rates of hematuria, and achieved higher rates of proteinuric remission (34.3%) vs PBO (12.7%). At 9 mos, uPCR-24h reduction was consistent across subgroups, including SGLT2i use. No deaths occurred; safety was comparable between groups.
Conclusion
Sibeprenlimab reduced proteinuria and biomarkers and led to higher rates of hematuric/proteinuric remission up to 12 mos, with favorable safety; benefits were consistent across subgroups. VISIONARY is ongoing, evaluating sibeprenlimab’s safety and efficacy (eGFR) over 24 mos.
Funding
- Commercial Support – Otsuka Pharmaceutical Development & Commercialization, Inc. (Princeton, NJ, USA)