Guselkumab (Anti-IL 23 Monoclonal Antibody) for Alcohol Associated Liver Disease
Status:
Recruiting
Trial end date:
2024-03-01
Target enrollment:
Participant gender:
Summary
This is a phase I study of guselkumab, a humanized anti-IL23 monoclonal antibody, for
patients with alcoholic liver disease. This drug is approved for the use in psoriatic
arthritis but not for alcoholic liver disease. The investigators will be using a standard 3+3
phase I dose escalation trial design, the dose levels will start from 30 mg, 70 mg and to 100
mg, a maximum total of 24 patients will be evaluable. In this study the investigators propose
to establish safety of the product in those with alcoholic liver disease and efficacy
(secondary endpoint) will be determined by biomarkers for liver inflammation and fibrosis
surrogate biomarkers.