Clinical Trial: A Study of Zetomipzomib (KZR-616) in Patients With Autoimmune Hepatitis (PORTOLA)

Study Status: RECRUITING
Recruit Status: RECRUITING
Study Type: INTERVENTIONAL

Official Title: 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

Brief Summary: This is a Phase 2a, multi-center, placebo-controlled study in which patients with autoimmune hepatitis will receive zetomipzomib or placebo in addition to standard-of-care for 24 weeks; an optional open-label extension period allows patients to receive zetomipzomib (KZR-616) for an additional 24 weeks of treatment.

Detailed Summary:

This is a Phase 2a, multi-center, randomized, double-blind, placebo-controlled study with an open-label extension to evaluate safety, tolerability, and efficacy of zetomipzomib in patients with autoimmune hepatitis (AIH) who have not benefited from standard-of-care treatment, had an incomplete response to ?3 months of standard-of-care treatment, or had a disease flare after standard of care.

Zetomipzomib or placebo will be administered weekly for a 24-week treatment period in addition to standard-of-care (glucocorticoids), followed by a 4-week off-treatment safety follow-up period.
Zetomipzomib and placebo will be administered subcutaneously (SC) once weekly.

At the end of the 24-week treatment period, eligible patients from both the zetomipzomib- and placebo-treated arms who complete the double-blind treatment period can enroll in the open-label extension period to receive an additional 24 weeks of treatment with zetomipzomib.

Primary completion date represents the anticipated completion date of the double-blind portion of the study.
Study completion date represents the anticipated completion date of the open-label extension portion of the study.

Sponsor: Kezar Life Sciences, Inc.

Current Primary Outcome: Proportion of patients who achieve complete biochemical remission (CR) with successful glucocorticoid taper by Week 24.

Original Primary Outcome: Proportion of patients who achieve complete biochemical remission (CR) with successful glucocorticoid taper by Week 24.

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Kezar Life Sciences, Inc.

Dates:
Date Received: September 29, 2022
Date Started: May 23, 2023
Date Completion: May 23, 2023
Last Updated: December 04, 2023
Last Verified: December 01, 2023