A Randomized Double-blind Placebo-controlled Phase 2a Study to Evaluate the Safety and Efficacy of Zetomipzomib (KZR-616) in Patients with Autoimmune Hepatitis

Brief description of study

This is a Phase 2a, multi-center, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, and efficacy of zetomipzomib in patients with AIH who have failed standard-of-care treatment, had an incomplete biochemical response to =3 months of standard-of-care treatment, or had a disease flare after standard-of-care treatment.

A screening period of up to 4 weeks will precede Day 1. Eligible patients will be randomized in a 2:1 ratio on Day 1 (Visit 2) to receive either standard-of-care (glucocorticoids) with zetomipzomib (Active Treatment group), or standard-of-care with Placebo (Control group). The first dose of investigational medicinal product (IMP) will be 30 mg zetomipzomib or placebo, followed by weekly doses of 60 mg zetomipzomib or placebo for the remaining 23 weeks of the treatment period. Zetomipzomib or placebo will be administered weekly for a 24-week treatment period, followed by a 4-week off-treatment safety follow-up period. Efficacy and safety will be assessed throughout the study through monitoring of vital signs, clinical laboratory tests, and physical examinations, and by recording and analyzing all adverse events (AEs) and serious AEs (SAEs).

Clinical Study Identifier: s23-00425
Principal Investigator: Raiya Sarwar.

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