NCT05781750

A Study of Zetomipzomib (KZR-616) in Patients With Active Lupus Nephritis (PALIZADE)

A Phase 2b, Randomized, Controlled Double-blind, Multicenter Study Comparing the Efficacy and Safety of Zetomipzomib (KZR-616) 30 mg or 60 mg With Placebo in Patients With Active Lupus Nephritis

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 84 (actual)
• Sponsor: Kezar Life Sciences, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study was to assess the efficacy and safety of zetomipzomib (30 mg or 60 mg) compared with placebo in achieving renal response after 52 weeks of treatment in patients with active lupus nephritis (LN).

Detailed description

This study aimed to investigate whether zetomipzomib, added to standard of care treatment in patients with active LN, was able to reduce disease activity over a treatment period of 52 weeks. The background standard of care therapy was mycophenolate mofetil (MMF) and initial optional treatment with IV methylprednisolone, followed by a tapering course of oral corticosteroids. Patients were required to have a diagnosis of LN according to established diagnostic criteria and clinical and biopsy features suggestive of active nephritis. Patients were 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 was to 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 was also assessed throughout the study to ensure an acceptable safety profile.

Conditions

• Lupus Nephritis

Interventions

Type	Name	Description
DRUG	zetomipzomib	Subcutaneous injection of zetomipzomib
DRUG	placebo	Subcutaneous injection of placebo

Timeline

• Start date: 2023-11-03
• Primary completion: 2024-11-08
• Completion: 2024-11-08
• First posted: 2023-03-23
• Last updated: 2025-12-05
• Results posted: 2025-12-05

Locations

50 sites across 12 countries: United States, Argentina, Brazil, China, Colombia, Greece, Guatemala, India, Malaysia, Philippines, South Africa, South Korea

Regulatory

• FDA-regulated drug study