A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Zetomipzomib in Patients with Active Lupus Nephritis

Phase 2

• Conditions: M321 Systemic lupus erythematosus with organ or system involvement; Systemic lupus erythematosus with organ or system involvement; M321

• Registration Number: PER-028-23
• Lead Sponsor: Kezar Life Sciences, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-04-18
• Last Update Posted: 20 August 2024

Recruitment & Eligibility

• Status: Without startig enrollment
• Sex: All
• Target Recruitment: 0

Inclusion Criteria

1.Is able to provide written informed consent before any study-related procedures are performed.
2.Is aged =18 years at the time of signing the informed consent.
3.Has a body mass index of =18 kg/m2.
4.eGFR =30 mL/min/1.73 m^2
5.Unequivocally positive ANA test result and/or a positive anti-dsDNA serum antibody test
6.Diagnosis of LN according to 2003 or 2018 ISN/RPS criteria and confirmed by renal biopsy performed within 12 months prior to Screening.
7.UPCR =1.0 (Class III/IV +/-V) or UPCR =2.0 (Class V)
8.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 Known intolerance to MMF or equivalent and corticosteroids

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
- 24-hour urine test<br>- Test of estimated glomerular filtration rate (eGFR)<br> NAME OF THE RESULT: The proportion of patients achieving complete renal response (CRR) at Week 37<br> PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE<br> PRIMARY RESULT: - 24 hour urine test: Screening, weeks 13, 25, and 37;<br> - eGFR: All study visits from selection, except week 2 visit ;Adverse Events Registration<br> NAME OF THE RESULT: The incidence and severity of Adverse Events (AEs) for each treatment group and patients treated with zetomipzomib compared with placebo.<br> PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE<br> PRIMARY RESULT: From Week 1 to Week 52, Week 53, Week 56, and Early Termination Visit (ETV)