A Study of Zigakibart in Adults With IgA Nephropathy

Summary

Safety and Efficacy of BION-1301 in Adults with IgA Nephropathy

Timeline

Start

2023-07-06

Primary completion

2027-08-10

Completion

2028-01-25

Publications

• Dulos J, Kreijtz J, Vink P, Cotton V, Kuo JJ, Lo J, Jansen W, Bakker J, Driessen L, Guadagnoli M, van Zandvoort P, Warncke M, Medema JP, Barratt J, van Eenennaam H, Van Elsas A. Zigakibart Potently Inhibits A Proliferation-Inducing Ligand-Mediated IgA Production, Addressing IgAN Pathogenesis Root Causes. Kidney Int Rep. 2026 Apr 6;11(6):106516. doi: 10.1016/j.ekir.2026.106516. eCollection 2026 Jun.
• Kooienga L, Lo J, Lee EY, Kim SG, Thomas H, Workeneh B, Agha I, Song Y, Smith W, van Eenennaam H, Van Elsas A, Dulos J, Barratt J. Zigakibart demonstrates clinical safety and efficacy in a Phase 1/2 trial of healthy volunteers and patients with IgA nephropathy. Kidney Int. 2025 Sep;108(3):445-454. doi: 10.1016/j.kint.2025.05.006. Epub 2025 Jun 5.
• Ahmad SB, Jefferson JA. Targeting B Cells and Plasma Cells in Glomerular Disease. J Am Soc Nephrol. 2025 Jun 4;36(9):1844-1857. doi: 10.1681/ASN.0000000772.
• Tunnicliffe DJ, Reid S, Craig JC, Samuels JA, Molony DA, Strippoli GF. Non-immunosuppressive treatment for IgA nephropathy. Cochrane Database Syst Rev. 2024 Feb 1;2(2):CD003962. doi: 10.1002/14651858.CD003962.pub3.

Drugs

Indications