Clinical Hold Slapped on Kezar Lupus Trial

FDA has placed a clinical hold on Kezar Life Sciences’ IND for zetomipzomib and its investigational use in treating lupus nephritis (LN). The agency action follows the company’s notification late last month that it was voluntarily suspending enrollment and dosing in its Phase 2b PALIZADE clinical trial of zetomipzomib in patients with active LN based on a recommendation by the trial’s independent data monitoring committee. The committee reviewed emerging safety data, including an assessment of four Grade 5 (fatal) serious adverse events (SAEs) that occurred in patients enrolled in the Philippines and Argentina.

“At this time, our zetomipzomib IND for the treatment of autoimmune hepatitis is unaffected,” a company statement says. “Our Phase 2a PORTOLA clinical trial of zetomipzomib in patients with autoimmune hepatitis remains active, and we have not observed any Grade 4 or 5 SAEs in the PORTOLA trial to date.”