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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.
Full description
This is a Phase 2a, multi-center, randomized, double-blind, placebo-controlled study with an open-label extension to evaluate safety, tolerability, and efficacy of zetomipzomib in patients with autoimmune hepatitis (AIH) who have not benefited from standard-of-care treatment, had an incomplete response to ≥3 months of standard-of-care treatment, or had a disease flare after standard of care.
Zetomipzomib or placebo will be administered weekly for a 24-week treatment period in addition to standard-of-care (glucocorticoids), followed by a 4-week off-treatment safety follow-up period. Zetomipzomib and placebo will be administered subcutaneously (SC) once weekly.
At the end of the 24-week treatment period, eligible patients from both the zetomipzomib- and placebo-treated arms who complete the double-blind treatment period can enroll in the open-label extension period to receive an additional 24 weeks of treatment with zetomipzomib.
Primary completion date represents the anticipated completion date of the double-blind portion of the study. Study completion date represents the anticipated completion date of the open-label extension portion of the study.
Enrollment
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Inclusion and exclusion criteria
Key Inclusion Criteria for the Double-blind Treatment Period:
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:
Must be willing to use and taper glucocorticoid therapy.
Must be willing to use effective contraception.
Key Exclusion Criteria for the Double-blind Treatment Period:
Key Inclusion Criteria for the Open-label Extension Period:
Same as Double-blind Treatment Period inclusion criteria, except the following modifications:
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 at 5 mg/day or continue to taper glucocorticoid therapy.
Key Exclusion Criteria for the Open-label Extension Period:
•. Same as Double-blind Treatment Period except no need to re-test for HIV, HBV, HCV, and TB.
Primary purpose
Allocation
Interventional model
Masking
24 participants in 3 patient groups, including a placebo group
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Central trial contact
Kezar Life Sciences, Inc.
Data sourced from clinicaltrials.gov
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