Kidney Week

Abstract: INFO16-FR

PREVAIL: A Phase 3 Trial of Felzartamab in Adults with IgAN

Session Information

• Informational Posters - 2
  November 07, 2025 | Location: Exhibit Hall, Convention Center
  Abstract Time: 10:00 AM - 12:00 PM

Category: Glomerular Diseases

• No subcategory defined

Authors

• Perkovic, Vlado, Faculty of Medicine, University of New South Wales Sydney, Sydney, New South Wales, Australia

Vlado Perkovic, MBBS, PhD, FASN

• Barratt, Jonathan, Department of Cardiovascular Sciences, University of Leicester, Leicester, United Kingdom

Jonathan Barratt, MBChB, PhD

• Liew, Adrian, The Kidney & Transplant Practice, Mount Elizabeth Novena Hospital, Singapore, Singapore

Adrian Liew, MD, MBBS, FASN

• Jha, Vivekanand, George Institute for Global Health, UNSW, New Delhi, India

Vivekanand Jha, MD

• Rizk, Dana V., Division of Nephrology, University of Alabama at Birmingham, Birmingham, Alabama, United States

Dana V. Rizk, MD

• Floege, Jürgen, Division of Nephrology and Cardiology, RWTH Aachen University, Aachen, Germany

Jürgen Floege, MD

• Reich, Heather N., Department of Medicine, Division of Nephrology, University Health Network, University of Toronto, Toronto, Ontario, Canada

Heather N. Reich, MD, PhD

• Shah, Millie, Biogen, South San Francisco, California, United States

Millie Shah, PhD

• Chinn, Leslie W., Biogen, South San Francisco, California, United States

Leslie W. Chinn

• Beckett, Valeria, Biogen, South San Francisco, California, United States

Valeria Beckett

• Jones, Nicholas S, Biogen, South San Francisco, California, United States

Nicholas S Jones, PharmD

• Alenizi, Saif A., Biogen, South San Francisco, California, United States

Saif A. Alenizi

• Schwartz, Brian, Biogen, South San Francisco, California, United States

Brian Schwartz

• Patel, Uptal D., Biogen, South San Francisco, California, United States

Uptal D. Patel, MD

• Lafayette, Richard A., Division of Nephrology, Department of Medicine, Stanford University, Stanford, California, United States

Richard A. Lafayette, MD

Description

IgA nephropathy (IgAN), the most common form of primary glomerulonephritis, involves accumulation of immune complexes in the glomerular mesangium, causing kidney injury and dysfunction. Felzartamab, a fully human IgG1 monoclonal antibody, selectively targets CD38⁺ plasma cells and plasmablasts, the source of pathogenic antibodies that form immune complexes. In the Phase 2 IGNAZ study, felzartamab was generally well tolerated and led to a rapid and durable reduction in proteinuria and a slowing of estimated glomerular filtration rate (eGFR) decline, suggesting potential disease modification.

PREVAIL (NCT06935357) is a randomized, double-blind, placebo-controlled Phase 3 study. Approximately 454 adults with biopsy-confirmed IgAN will receive IV felzartamab or placebo over 24 weeks and be followed for an additional 80 weeks without treatment. Participants will be assigned to the main study (screening eGFR ≥30 mL/min/1.73 m²) or exploratory cohort (screening eGFR ≥20 and <30 mL/min/1.73 m²). Inclusion criteria include proteinuria of ≥1.0 g/day or 24-hr urine protein-creatinine ratio (UPCR) ≥0.8 g/g. Participants must be clinically stable on maximally tolerated angiotensin-converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB) for ≥12 weeks prior to screening. Concomitant stable doses over 12 weeks of sodium-glucose cotransporter-2 inhibitors, endothelin receptor antagonists, and/or mineralocorticoid receptor antagonists, or those intolerant of ACEi/ARBs are allowed. The primary endpoint is percent change from baseline in 24-hr UPCR at 36 weeks. The key secondary endpoint is change from baseline in eGFR at 104 weeks.

PREVAIL is the first Phase 3 trial investigating CD38⁺ targeting in IgAN. The results will further inform on the safety and efficacy of this novel therapy with the potential to specifically target the pathogenic cellular drivers of IgAN and disease relevant antibody production.

Funding

• This study was sponsored by Biogen.