A Study of Zetomipzomib (KZR-616) in Patients With Autoimmune Hepatitis (PORTOLA)
C
Craig Lammert, MD
Primary Investigator
Enrolling By Invitation
18 years and older
All
Phase
2
24 participants needed
1 Location
Brief description of study
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.
Detailed description of study
This is a Phase 2a, multi-center, randomized, double-blind, placebo-controlled study tovaluate safety, tolerability, and efficacy of zetomipzomib in patients with autoimmune
hepatitis (AIH) who have not benefited from standard-of-care treatment, had an incomplete≥3 months of standard-of-care treatment, or had a disease flare after standard of.
Zetomipzomib or placebo will be administered weekly for a 24-week treatment period inddition to standard-of-care (glucocorticoids), followed by a 4-week off-treatment safetyw-up period. Zetomipzomib and placebo will be administered subcutaneously (SC) once
weekly.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Autoimmune Hepatitis
-
Age: 18 Years
-
Gender: All
Key Inclusion Criteria:
- Must be aged ≥18 years.
- Must have a clinical diagnosis of AIH and signs of active disease or diseasedespite standard-of-care therapy for ≥3 months, including:
- Screening ALT values that are 1.25 to 10 times the upper limit of the normalge (ULN)
- Liver biopsy results with Ishak score (modified HAI) ≥5/18 indicating activeAIH, from a biopsy performed at Screening, or within 6 months prior tog
- Mild or no hepatic impairment (Child Pugh category A)
- Must be willing to use and taper glucocorticoid therapy.
- Must have a clinical diagnosis of AIH and signs of active disease or diseasedespite standard-of-care therapy for ≥3 months, including:
Key Exclusion Criteria:
- Have a concomitant diagnosis of primary biliary sclerosis, primary sclerosingholangitis, IgG 4 related cholangitis, drug related AIH (at Screening) or a historydrug-related AIH.
- Are receiving oral or injectable immunomodulating treatment for any other autoimmunedisease prior to enrollment in the study. Patients who have been using such treatmentsust follow the specified washout periods.
- Have an active infection (eg, acute hepatitis E, cytomegalovirus, or Epstein-Barrvirus) requiring systemic therapy with antibiotic, antiviral, or antifungal treatment,has had any febrile illness within 7 days prior to Day -1.
- Have a history of thyroiditis, celiac disease, or other autoimmune disorder known tobe associated with transaminitis.
- Have liver cirrhosis with significant impairment of liver function (Child Pughgory B or C) or have decompensated cirrhosis.
- Patients with histology confirmed coincident non-alcoholic steatohepatitis.
Updated on
01 Aug 2024.
Study ID: KZR-616-208
Please visit our main page to search for other studies you may be interested in.
If you need help finding a study or have any questions, please contact us at inhealth@iu.edu
