CTIS2022-502227-22-00
Recruiting
Phase 1
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 - KZR-616-202
ConditionsAutoimmune diseaseMedDRA version: 20.0Level: LLTClassification code: 10029142Term: Nephritis systemic lupus erythematosus Class: 10038359MedDRA version: 21.1Level: PTClassification code: 10025140Term: Lupus nephritis Class: 100000004857Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Autoimmune disease
- Sponsor
- Kezar Life Sciences Inc.
- Enrollment
- 247
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Not specified
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A Study of Zetomipzomib (KZR616) in Patients with ActiveLupus NephritisHealth Condition 1: M321- Systemic lupus erythematosus withorgan or system involvementCTRI/2023/12/060561Kezar Life Sciences, Inc.
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