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

Brief description of study

This study is being done to find out how safe, tolerable, and effective an experimental drug called zetomipzomib (KZR 616) is as an injection under the skin once a week for 52 weeks in patients with active lupus kidney disease. This will be determined by comparing the effects of the study drug, zetomipzomib (at either a 30 mg or 60 mg dose), to a placebo. A placebo is a treatment that looks identical to the study drug, contains no active ingredients, and is administered the same way as the study drug. Researchers also hope to learn more about how zetomipzomib affects proteins in the blood and urine.

Most medications for treating autoimmune diseases, including Lupus Nephritis (LN), suppress the immune system (like steroids) or target one aspect of the immune system to help counter the chronic inflammatory state associated with these conditions. These treatment approaches may not be effective for many patients and long-term use of immunosuppressants results in significant complications like infections, muscle weakness, liver damage, and osteoporosis (brittle bones). Instead of suppressing the immune system, zetomipzomib blocks inflammatory activity without suppressing immune function.

Zetomipzomib (KZR 616) is being developed as a treatment for patients with active LN. "Experimental" means the drug has not been approved by any authority around the world, including the United States (US) Food and Drug Administration (FDA).

Clinical Study Identifier: s22-01115
Principal Investigator: Amit Saxena.
Other Investigator: Janine M. Sullivan.

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