Clinical Trial: PORTOLA
Condition
Autoimmune Hepatitis (AIH)
Overview
PORTOLA is a randomized, double-blind, placebo-controlled phase 2a study with an open-label extension to evaluate the safety and efficacy of zetomipzomib (KZR-616) in people living with autoimmune hepatitis (AIH). Zetomipzomib is a first-in-class, investigational product being studied for the treatment of autoimmune diseases, including autoimmune hepatitis, a rare and chronic autoimmune liver disease. Zetomipzomib acts by inhibiting the immunoproteasome, a structure found in immune cells that helps to regulate the normal functioning of the immune system.
Participation Eligibility
Inclusion Criteria:
- Must be at least 18 years of age
- Must have a clinical diagnosis of AIH and signs of active disease despite having received your current medication for ≥ 3 months, or have experienced a disease flare after experiencing a good prior treatment response
- Must be willing to reduce the dose of your steroid therapy
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