NCT04736966

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: University of California, San Diego · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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

Detailed 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.

Conditions

• Alcoholic Liver Disease

Interventions

Type	Name	Description
DRUG	Guselkumab 30mg	30mg of Guselkumab administered by subcutaneous injection
DRUG	Guselkumab 70mg	70mg of Guselkumab administered by subcutaneous injection
DRUG	Guselkumab 100mg	100mg of Guselkumab administered by subcutaneous injection

Timeline

• Start date: 2021-03-03
• Primary completion: 2024-03-31
• Completion: 2024-03-31
• First posted: 2021-02-03
• Last updated: 2024-08-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study