Safety, Pharmacokinetics and Preliminary Efficacy Study of CFZ533 in Patients With Lupus Nephritis.

Summary

This study was to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary therapeutic efficacy of multiple doses of CFZ533 anti-CD40 monoclonal antibody in patients with moderately active lupus nephritis.

Timeline

Start

2018-09-12

Primary completion

2023-06-29

Completion

2023-06-29

Publications

• Shen N, Weinmann-Menke J, Malvar A, Serra-Roma A, Weiss M, Danekula R, Sips C, Rohr J, Felten R, Gergely P, Shisha T. Efficacy, pharmacokinetics and safety of iscalimab (CFZ533) in patients with proliferative lupus nephritis: a randomised, double-blind, placebo-controlled, phase II study. RMD Open. 2025 Aug 14;11(3):e005557. doi: 10.1136/rmdopen-2025-005557.

Drugs

Indications