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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

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: 04 Jun 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

  • 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.
  • 25 Mar 2025 According to a Kezar Life Sciences media release, Kezar Life Sciences will host a webcast and conference call today, March 25, 2025, at 8:00 a.m. ET to discuss topline results from the PORTOLA Phase 2a clinical trial.

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