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

Phase 1

Recruiting

• Conditions: Autoimmune disease; MedDRA version: 20.0Level: LLTClassification code: 10029142Term: Nephritis systemic lupus erythematosus Class: 10038359; MedDRA version: 21.1Level: PTClassification code: 10025140Term: Lupus nephritis Class: 100000004857; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: CTIS2022-502227-22-00
• Lead Sponsor: Kezar Life Sciences Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-06-09
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 247

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

Exclusion Criteria

1.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 2. Has received dialysis within the 52 weeks prior to Screening 3. Positive test at Screening for HIV, hepatitis B/C 4. Known intolerance to MMF or equivalent and corticosteroids

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the efficacy and safety of zetomipzomib in patients with active Class III or IV (with or without Class V; Class III/IV +/-V) LN and for those with pure Class V LN;Secondary Objective: To evaluate zetomipzomib compared with placebo in patients with active Class III/IV +/-V LN on background MMF or equivalent, and corticosteroids based upon current guideline-driven standard of care;Primary end point(s): The primary efficacy endpoint is the proportion of patients achieving CRR at Week 37.