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

NCT05569759 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2026-01-13

Study results available
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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.

Conditions

  • Autoimmune Hepatitis

Interventions

DRUG

zetomipzomib

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

DRUG

placebo

Subcutaneous injection of placebo

DRUG

zetomipzomib in open-label extension

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

Sponsors & Collaborators

  • Kezar Life Sciences, Inc.

    lead INDUSTRY

Principal Investigators

  • Craig Lammert, MD · Indiana University

  • Ethan Weinberg, MD · University of Pennsylvania

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-23
Primary Completion
2025-04-30
Completion
2025-04-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05569759 on ClinicalTrials.gov