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A Randomized, Double-blind, Placebo-controlled, Phase 2a Study With Open-label Extension to Evaluate the Safety and Efficacy of Zetomipzomib (KZR-616) in Patients With Autoimmune Hepatitis

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Trial Profile

A Randomized, Double-blind, Placebo-controlled, Phase 2a Study With Open-label Extension to Evaluate the Safety and Efficacy of Zetomipzomib (KZR-616) in Patients With Autoimmune Hepatitis

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 29 Jul 2025

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At a glance

  • Drugs Zetomipzomib (Primary) ; Prednisone
  • Indications Autoimmune hepatitis
  • Focus Adverse reactions; Proof of concept; Therapeutic Use
  • Acronyms PORTOLA
  • Sponsors Kezar Life Sciences

Most Recent Events

  • 15 Jul 2025 According to a Kezar Life Sciences media release, company announced that the Division of Hepatology and Nutrition of the U.S. Food and Drug Administration (FDA) has lifted the partial clinical hold on the completed PORTOLA Phase 2a clinical trial evaluating zetomipzomib, a first-in-class selective immunoproteasome inhibitor, in patients with autoimmune hepatitis (AIH).
  • 30 May 2025 Status changed from active, no longer recruiting to completed.
  • 13 May 2025 According to a Kezar Life Sciences media release, company is responding to the information request from the FDA Division of Hepatology and Nutrition to resolve the partial clinical hold on the PORTOLA Phase 2a clinical trial.

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