Kezar Life Sciences (KZR) said Monday it has voluntarily stopped the enrollment of new patients and the dosing of ongoing patients in its phase 2b Palizade trial of zetomipzomib in patients with active lupus nephritis, pending further evaluation.
The trial is assessing the efficacy and safety of two dose levels of zetomipzomib, with 84 people enrolled in the study to date, the company said.
Kezar said it suspended enrollment and dosing in the trial at the recommendation of the Independent Data Monitoring Committee after a review of safety data, including an assessment of four fatal serious adverse events that happened during the trial in the Philippines and Argentina.
The review showed that there is a "common pattern of symptoms and proximity to dosing" in three of the fatalities and "a similar proximity to dosing" in non-fatal serious adverse events, the company said.
Kezar said it remains blinded as to which patients were on the zetomipzomib or placebo portions of the trial.
Meanwhile, the company said its phase 2a Portola trial of zetomipzomib in people with autoimmune hepatitis has completed enrollment and is still active.
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