Zetomipzomib trial in lupus nephritis paused after four patient deaths
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Kezar Life Sciences has paused a phase 2b trial of zetomipzomib in active lupus nephritis after reporting four patient deaths, according to a press release from the manufacturer.
Enrollment and dosing in the PALIZADE trial was suspended, pending further evaluation, at the recommendation of an independent data monitoring committee after four fatal, or grade 5, serious adverse events among participants in the Philippines and Argentina, according to the release. Eighty-four patients have been dosed in the trial so far.
“Our top priority is the safety of every patient who participates in our clinical trials,” Kezar Life Sciences CEO Chris Kirk, PhD, said in the release. “Lupus nephritis represents a life-threatening medical condition in need of new therapies.
“We will continue to work with the site investigators to learn more about each of these cases and hope to have an informed discussion with the [independent data monitoring committee] and regulatory authorities as we look to continue the zetomipzomib development program in lupus nephritis and autoimmune hepatitis,” he added. “We will provide additional information regarding this investigation and the zetomipzomib development program at the appropriate time.”
The independent data monitoring committee’s review found “a common pattern of symptoms and proximity to dosing” among three of the deaths, according to the release. Other non-fatal serious adverse events also displayed “similar proximity to dosing.”
Although enrollment and dosing is suspended, Kezar expects to “evaluate the totality of the data regarding the [serious adverse events] and determine the next steps and potential risk mitigation strategies,” read the release.
In the PALIZADE trial, patients with active lupus nephritis around the world were given either 30 mg or 60 mg of zetomipzomib (KZR-616, Kezar Life Sciences), or placebo, subcutaneously for 52 weeks in combination with background therapy.
Zetomipzomib, a selective immunoproteasome inhibitor, is still being investigated for autoimmune hepatitis in another phase 2a trial, PORTOLA, the release stated. That trial has completed enrollment and remains active, with no grade 4 or 5 serious adverse events reported at this time.
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