CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 24 enrolled
Drug / intervention
zetomipzomib +2 moredrug
Likely dose
zetomipzomib 60 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05569759
NCT05569759Phase 2Completed
CompareCT.gov

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

Kezar Life Sciences, Inc.·interventional·Posted Oct 6, 2022·Updated Jan 13, 2026

In Brief

A Phase 2 clinical trial evaluating zetomipzomib, placebo, and 1 other intervention for Autoimmune Hepatitis. Completed, enrolled 24 participants across 24 sites.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAutoimmune Hepatitis
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2023202420252026
First PostedOct 6, 2022
Enrollment StartMay 23, 2023
Primary CompletionApr 30, 2025
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 3.7 years ago

Interventions

zetomipzomibdrug

Subcutaneous injection of zetomipzomib with a target dose of 60 mg weekly

placebodrug

Subcutaneous injection of placebo

zetomipzomib in open-label extensiondrug

Subcutaneous injection of zetomipzomib with a target dose of 60 mg weekly