A Study of Zetomipzomib (KZR616) in Patients with ActiveLupus Nephritis

Phase 2

• Conditions: Health Condition 1: M321- Systemic lupus erythematosus withorgan or system involvement

• Registration Number: CTRI/2023/12/060561
• Lead Sponsor: Kezar Life Sciences, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

Body mass index of = 18 kg/m2 (m square)

eGFR = 30 mL/min/1.73 m2 (m square)

-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
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary efficacy endpoint is the proportion of patients achieving complete renal response (CRR) at Week 37Timepoint: 37 Weeks

Secondary Outcome Measures

Name	Time	Method
Partial Renal Response (PRR)Timepoint: Week 37;Partial Renal Response (PRR) <br/ ><br>Complete Renal Response (CRR)Timepoint: Week 25;Partial Renal Response (PRR) <br/ ><br>Complete Renal Response (CRR)Timepoint: Week 53