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

Status: Not yet recruiting
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2

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.

Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No

• Must be aged ≥18 years.

• Must have a clinical diagnosis of AIH and signs of active disease or disease flare despite standard-of-care therapy for ≥3 months, 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.

Contact Information
Kezar Life Sciences, Inc.
(650) 822-5600
Julia Lawrence
Time Frame
Start Date: December 2022
Estimated Completion Date: September 2024
Target number of participants: 24
Experimental: zetomibzomib + standard-of-care (glucocorticoids)
Initial 30 mg dose of zetomipzomib, followed by weekly 60 mg doses of zetomipzomib, for the remaining 23 weeks of the treatment period.
Placebo Comparator: placebo + standard-of-care (glucocorticoids)
Initial 30 mg dose of placebo (sterile water for injection), followed by weekly 60 mg doses of placebo, for the remaining 23 weeks of the treatment period.
Leads: Kezar Life Sciences, Inc.

This content was sourced from clinicaltrials.gov

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