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Guselkumab (Anti-IL 23 Monoclonal Antibody) for Alcohol Associated Liver Disease

Alcoholic Liver Disease Clinical Trial

Official title:
A Phase I Clinical Trial to Determine the Safety and Tolerability of Anti-IL23 Monoclonal Antibody, for the Treatment of Patients With Alcohol Associated Liver Disease

Clinical Trial Summary

A Phase I clinical trial to determine the safety and tolerability of an anti-IL23 antibody for the treatment of patients with alcoholic liver disease

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04736966
Study type Interventional
Source University of California, San Diego
Contact Egbert Madamba
Phone 858-246-2227
Email emadamba@health.ucsd.edu
Status Recruiting
Phase Phase 1
Start date March 3, 2021
Completion date March 31, 2025
View Details
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