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

Study Purpose

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).

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05781750
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Kezar Life Sciences, Inc.
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Steven Kimmel, MDSumit Kumar, MDAmarilis Gonzalez, MDDavid Tietjen, MD
Principal Investigator Affiliation	West Broward Rheumatology Associates, Inc.Texas Kidney InstitutePhoenix Research Center, LLCNephrology Consultants, LLC
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	Argentina, Australia, Brazil, Croatia, Greece, Guatemala, India, Korea, Republic of, Malaysia, Philippines, Portugal, Puerto Rico, Singapore, South Africa, Spain, Taiwan, United Kingdom, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Lupus Nephritis
Study Website:	View Trial Website

Additional Details

This study aims to investigate whether zetomipzomib, added to standard of care treatment in patients with active LN, is able to reduce disease activity over a treatment period of 52 weeks. The background standard of care therapy will be mycophenolate mofetil (MMF) and initial optional treatment with IV methylprednisolone, followed by a tapering course of oral corticosteroids. Patients are required to have a diagnosis of LN according to established diagnostic criteria and clinical and biopsy features suggestive of active nephritis. Patients will be randomized in a 2:1 ratio to receive either zetomipzomib (30 mg or 60 mg) or placebo administered as a subcutaneous injection once weekly for 52 weeks, followed by a 4-week safety follow-up period. Efficacy will be assessed by measuring the level of proteinuria (as measured by urine protein to creatinine ratio [UPCR]) and estimated glomerular filtration rate (eGFR) as compared to current standard of care treatment. Safety will also be assessed throughout the study to ensure an acceptable safety profile.

Arms & Interventions

Arms

Experimental: zetomipzomib 30 mg + standard-of-care

Initial 30 mg dose of zetomipzomib, followed by weekly doses of 30 mg zetomipzomib through 52 weeks of the treatment period.

Experimental: zetomipzomib 60 mg + standard-of-care

Initial 30 mg dose of zetomipzomib, followed by weekly doses of 60 mg zetomipzomib through 52 weeks of the treatment period.

Placebo Comparator: placebo + standard-of-care

Initial 30 mg dose of placebo, followed by weekly doses (30 mg or 60 mg) of placebo through 52 weeks of the treatment period.

Interventions

Drug: - zetomipzomib

Subcutaneous injection of zetomipzomib

Drug: - placebo

Subcutaneous injection of placebo

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Nephrology Consultants, LLC, Huntsville, Alabama

Status

Recruiting

Address

Nephrology Consultants, LLC

Huntsville, Alabama, 35805

Site Contact

David Tietjen, MD

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