UPDATE: FDA Places Kezar Life Sciences’ Phase 2b Study of Zetomipzomib for Lupus Nephritis Treatment on Clinical Hold

The U.S. Food and Drug Administration (FDA) has placed a clinical hold on Kezar Life Sciences’ zetomipzomib, an investigational therapy for lupus nephritis (LN). This comes after Kezar Life Sciences reported they had voluntarily ended enrollment and dosage of their Phase 2b PALIZADE clinical trial at the recommendation of the trial’s Independent Data Monitoring Committee (IDMC). 

The PALIZADE study was a global, randomized, double-blind Phase 2b clinical trial that evaluated the efficacy and safety of two dose levels (30 mg and 60 mg) of zetomipzomib compared to the placebo and standard therapy in patients with active LN. There were 84 people participating in the study. The IDMC recommended trial suspension and halting dosage of zetomipzomib after a review of they reviewed emerging safety data which revealed grade 5 serious adverse events that have occurred with the death of four study participants in the Philippines and Argentina. The FDA will issue an official clinical hold letter to Kezar within the next 30 days. 

Continue to follow the Lupus Foundation of America for updates on zetomipzomib as well as other lupus clinical trials. Learn more about medications used to treat lupus.