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

Exclusion Criteria

• •Have a concomitant diagnosis of primary biliary sclerosis, primary sclerosing cholangitis, IgG 4 related cholangitis, drug related AIH (at Screening) or a history of drug-related AIH.
• •Have clinical evidence of significant unstable or uncontrolled diseases other than the disease under study.
• •Are receiving oral or injectable immunomodulating treatment for any other autoimmune disease prior to enrollment in the study. Patients who have been using such treatments must follow the specified washout periods.
• •Have an active infection (eg, acute hepatitis E, cytomegalovirus, or Epstein-Barr virus) requiring systemic therapy with antibiotic, antiviral, or antifungal treatment, or has had any febrile illness within 7 days prior to Day -1.
• •Have a history of thyroiditis, celiac disease, or other autoimmune disorder known to be associated with transaminitis.
• •Have liver cirrhosis with significant impairment of liver function (Child Pugh category B or C) or have decompensated cirrhosis.
• •Patients with histology confirmed coincident non-alcoholic steatohepatitis.
• •Same as Double-blind Treatment Period except no need to re-test for HIV, HBV, HCV, and TB.