Ignite Creation Date:
2025-12-24 @ 4:16 PM
Ignite Modification Date:
2026-01-15 @ 11:48 AM
Study NCT ID:
NCT04736966
Status:
COMPLETED
Last Update Posted:
2024-08-06
First Post:
2021-01-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Guselkumab (Anti-IL 23 Monoclonal Antibody) for Alcohol Associated Liver Disease
Sponsor:
University of California, San Diego
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: