A Phase 2b Study of Zetomipzomib (KZR-616) in Patients With Active Lupus Nephritis (PALIZADE)

• Status: Not yet recruiting
• Trial end date: 2026-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is 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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kezar Life Sciences, Inc.

Criteria

Key Inclusion Criteria:

• Body mass index of ≥18 kg/m^2

• eGFR ≥30 mL/min/1.73 m^2

• Unequivocally positive ANA test result and/or a positive anti-dsDNA serum antibody test

• Diagnosis of LN according to 2003 or 2018 ISN/RPS criteria and confirmed by renal biopsy performed within 12 months prior to Screening.

• UPCR ≥1.0 (Class III/IV +/-V) or UPCR ≥2.0 (Class V)

• Adequate hematologic, hepatic, and renal function

Key Exclusion Criteria:

• Current or medical history of:

• Central nervous system manifestations of SLE

• Overlapping autoimmune condition that may affect study assessments/outcomes

• Antiphospholipid syndrome with history of thromboembolic event of within the 52 weeks prior to Screening

• Thrombocytopenia or at high risk for developing clinically significant bleeding or organ dysfunction requiring therapies (i.e., plasmapheresis or acute blood or platelet transfusions

• Solid organ transplant or planned transplant during study

• Malignancy of any type, with exceptions for non-melanoma skin cancers and certain cancers >5 years ago

• Has received dialysis within the 52 weeks prior to Screening

• Positive test at Screening for HIV, hepatitis B/C

• Known intolerance to MMF or equivalent and corticosteroids