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
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.
• Must be aged ≥18 years.
‣ Must have a clinical diagnosis of AIH and signs of active disease despite standard-of-care therapy for ≥3 months or disease flare after experiencing complete remission induced by standard-of-care treatment, including:
• Screening ALT values that are 1.25 to 10 times the upper limit of the normal range (ULN)
∙ Liver biopsy results with Ishak score (modified HAI) ≥5/18 indicating active AIH, from a biopsy performed at Screening, or within 6 months prior to Screening
∙ Mild or no hepatic impairment (Child Pugh category A)
⁃ Must be willing to use and taper glucocorticoid therapy.
⁃ Must be willing to use effective contraception.
• Same as Double-blind Treatment Period inclusion criteria, except the following modifications:
‣ ALT value can be normal or, if elevated, in the range of 1.25 to 10 times the upper limit of normal
• Must have completed the Double-blind Period study visits through Week 24, including all Week 24 Visit assessments.
• Must be willing to maintain glucocorticoid therapy or continue to taper glucocorticoid therapy.