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
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
View:
• 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
Primary
Kezar Life Sciences, Inc.
clinicaltrials@kezarbio.com
(650) 822-5600
Backup
Julia Lawrence
jlawrence@kezarbio.com
Time Frame
Start Date: December 2022
Estimated Completion Date: September 2024
Participants
Target number of participants: 24
Treatments
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.
Authors
Related Therapeutic Areas
Sponsors
Leads: Kezar Life Sciences, Inc.