A Study of Zetomipzomib (KZR-616) in Patients with Active Lupus Nephritis (PALIZADE)
279 patients around the world
Available in Puerto Rico, Guatemala, United States
This study aims to investigate whether zetomipzomib, added to standard of care treatment
in patients with active LN, is able to reduce disease activity over a treatment period of
52 weeks. The background standard of care therapy will be mycophenolate mofetil (MMF) and
initial optional treatment with IV methylprednisolone, followed by a tapering course of
oral corticosteroids.
Patients are required to have a diagnosis of LN according to established diagnostic
criteria and clinical and biopsy features suggestive of active nephritis.
Patients will be randomized in a 2:1 ratio to receive either zetomipzomib (30 mg or 60
mg) or placebo administered as a subcutaneous injection once weekly for 52 weeks,
followed by a 4-week safety follow-up period. Efficacy will be assessed by measuring the
level of proteinuria (as measured by urine protein to creatinine ratio [UPCR]) and
estimated glomerular filtration rate (eGFR) as compared to current standard of care
treatment. Safety will also be assessed throughout the study to ensure an acceptable
safety profile.