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

NCT04736966 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: Anti-IL23 Trial Phase 1
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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

Conditions

Alcoholic Liver Disease

Outcome Measures

Primary Outcomes (1)

• Assess the safety and tolerability of Guselkumab

  Incidence of treatment-emergent adverse events: Outcome measures will include incidence of treatment-emergent adverse events and the proportion of subjects prematurely withdrawn from the study due to adverse events.

  48 Weeks

Study Arms (3)

Guselkumab 30mg

EXPERIMENTAL

Guselkumab administered by subcutaneous injection at Day 1 and Day 29

Drug: Guselkumab 30mg

Guselkumab 70 mg

EXPERIMENTAL

Guselkumab administered by subcutaneous injection at Day 1 and Day 29

Drug: Guselkumab 70mg

Guselkumab 100mg

EXPERIMENTAL

Guselkumab administered by subcutaneous injection at Day 1 and Day 29

Drug: Guselkumab 100mg

Interventions

Guselkumab 30mg DRUG

30mg of Guselkumab administered by subcutaneous injection

Also known as: Tremfya

Guselkumab 30mg

Guselkumab 70mg DRUG

70mg of Guselkumab administered by subcutaneous injection

Also known as: Tremfya

Guselkumab 70 mg

Guselkumab 100mg DRUG

100mg of Guselkumab administered by subcutaneous injection

Also known as: Tremfya

Guselkumab 100mg

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to provide written informed consent (either from patient or patient's legally acceptable representative)
• Male or female patients 21 years of age or older with BMI ≥ 20 to ≤ 45 kg/m2
• Patients with moderate alcohol use disorder (AUD) as defined by the AASLD Practice Guidance to have ≥ 4 symptoms out of 11:
• Alcohol is often taken in larger amounts and/or over a longer period than the patient intended.
• Persistent attempts or one or more unsuccessful efforts made to cut down or control alcohol use.
• A great deal of time is spent in activities necessary to obtain alcohol, use alcohol, or recover from effects.
• Craving or strong desire or urge to use alcohol
• Recurrent alcohol use resulting in a failure to fulfill major role obligations at work, school, or home.
• Continued alcohol use despite having persistent or recurrent social or interpersonal problem caused or exacerbated by the effects of the alcohol.
• Important social, occupational or recreational activities given up or reduced because of alcohol use.
• Recurrent alcohol use in situations in which it is physically hazardous.
• Alcohol use is continued despite knowledge of having a persistent or recurrent physical or psychological problem that is likely to have been caused or exacerbated by the alcohol.
• Tolerance, as defined by either of the following:
• <!-- -->
• Markedly increased amounts of the alcohol in order to achieve intoxication or desired effect

You may not qualify if:

• History or evidence of other or concomitant cause(s) of liver disease as a result of:
• Autoimmune liver disease
• Wilson disease (ceruloplasmin levels \< 10 mcg/L)
• Vascular liver disease
• Drug induced liver disease
• Surface antigen positive hepatitis B (HBsAg+). Note: patients with isolated core antibody (HBcAb) are not excluded.
• Acute hepatitis A
• Acute HCV or chronic hepatitis C with a history of decompensated cirrhosis. (Note: patients with stable chronic Hep C Virus (HCV) or successfully treated HCV are not excluded. Anti-HBc antibody positive patients will be given a prophylaxis with entecavir 0.5mg PO once daily, starting one week prior to start of guselkumab to 6 months after the last dose of guselkumab)
• Noninvasive criteria to exclude cirrhosis:
• MRE ≥ 3.63 kPa; if MRE not available, VCTE ≥ 16 kPa
• FIB-4 ≥ 2.67
• Imaging evidence of varices, splenomegaly, ascites, or shrunken cirrhotic liver
• Co-infection with human immunodeficiency virus (HIV)
• History or evidence of positive Urine Drug Screen (amphetamines, barbiturates, benzodiazepines, cocaine and opiates) except THC and legal prescription medications.
• Any active malignancies other than curatively treated skin cancer (basal cell or squamous cell carcinomas) or any other malignancy diagnosed within the last five years

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

University of California, San Diego

La Jolla, California, 92093, United States

Location

MeSH Terms

Conditions

Liver Diseases, Alcoholic

Interventions

guselkumab

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Alcohol-Induced Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders

Study Officials

• Rohit Loomba

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: January 19, 2021
• First Posted: February 3, 2021
• Study Start: March 3, 2021
• Primary Completion: March 31, 2024
• Study Completion: March 31, 2024
• Last Updated: August 6, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)