Syneos Health - Phase 1b/2 Study of KZR-616-002 in Patients with Systemic Lupus Erythematosus with and without Nephritis

Brief description of study

This is a study of an experimental drug called KZR 616, a proteasome inhibitor, which is being developed as a treatment for patients with proliferative lupus nephritis (LN). LN is a type of kidney disease caused by systemic lupus erythematosus (SLE or lupus). “Experimental” means the drug has not been approved by the US Food and Drug Administration (FDA). The purpose of the study is to find out how safe, tolerable, and effective KZR-616 is, when given as an injection under the skin once a week for 24 weeks and added to the current regimen of at least 1 immunosuppressant agent. Researchers also hope to learn more about how KZR-616 affects proteins in the blood.


Clinical Study Identifier: s19-01855
ClinicalTrials.gov Identifier: NCT03393013
Principal Investigator: Amit Saxena.
Other Investigator: Janine M. Sullivan.


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