Kidney Week

Abstract: INFO12-FR

BEYONDx: A Multicenter Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of Zigakibart in Adults with Primary 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

• Campbell, Kirk N., University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania, United States

Kirk N. Campbell, MD, FASN

• Hahn, Carolyn M, Novartis Pharmaceuticals Corporation, East Hanover, New Jersey, United States

Carolyn M Hahn

• Linden, Ellena A., Novartis Pharmaceuticals Corporation, East Hanover, New Jersey, United States

Ellena A. Linden, MD, FASN

• Smith, William T., Novartis Pharmaceuticals Corporation, East Hanover, New Jersey, United States

William T. Smith, MD

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

Vlado Perkovic, MBBS, PhD, FASN

Description

IgAN is the most common primary glomerulonephritis worldwide. It is widely accepted that the first step in the pathogenesis of IgAN is the increased production of galactose-deficient immunoglobulin A1 (Gd-IgA1) mediated by A PRoliferation-Inducing Ligand (APRIL), a TNF superfamily cytokine. Zigakibart is a humanized monoclonal antibody that binds to, and blocks APRIL and is currently being investigated for the treatment of patients with IgAN.
BEYONDx (NCT06858319) is a non-randomized, multicenter, open-label extension (OLE) study that will include participants from the Phase 3 BEYOND study, Phase 1/2 ADU-CL-19 study and other Novartis-sponsored clinical studies of zigakibart in IgAN. Key inclusion criteria require completion of the parent study and the investigator’s judgement that the participant may benefit from receiving open-label zigakibart. Key exclusion criteria include premature withdrawal from zigakibart parent studies; need for chronic dialysis (≥30 days) or kidney transplantation; use of systemic corticosteroid or immunosuppressive therapy; historical or current severe infection; and confirmed IgG levels < 3 g/L prior to first study treatment administration in the OLE study. Eligible participants will receive zigakibart 600 mg subcutaneously every 2 weeks (Q2W) until at least Week 96 (Figure). The primary objective is to evaluate the long-term safety and tolerability of zigakibart in patients with IgAN. Key secondary objectives are to evaluate the effect of zigakibart on proteinuria and eGFR, and to further characterize the pharmacodynamics and immunogenicity of zigakibart. Recruitment will start in Q3 2025.
This OLE study will evaluate long-term safety and tolerability as well as provide data on durability of efficacy of zigakibart in the treatment of adult patients with IgAN.

Figure. BEYONDx study design

Funding

• The study is sponsored by Novartis Pharma AG, Basel, Switzerland.