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Monoclonal Antibodies

Guselkumab for Alcoholic Liver Disease

Phase 1
Recruiting
Led By Rohit Loomba
Research Sponsored by University of California, San Diego
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male or female patients 21 years of age or older with BMI ≥ 20 to ≤ 45 kg/m2
Evidence of end-organ damage to the liver as defined by
Must not have
If female, known pregnancy, or has a positive serum pregnancy test, or is lactating/breastfeeding
Autoimmune liver disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 48 weeks
Awards & highlights

Summary

This trial will test the safety of a drug not approved for alcoholic liver disease in up to 24 patients. The goal is to also establish if the drug is effective in treating the disease by measuring biomarkers for liver inflammation and fibrosis.

Who is the study for?
Adults aged 21+ with a BMI of 20-45 kg/m2 and moderate alcohol use disorder, showing at least four specific symptoms related to alcohol dependency. Participants must have liver damage indicated by MRI or CAP scan results, recent alcohol consumption, and normal AST/ALT levels without active infections. Women must use birth control if able; men agree to contraception.Check my eligibility
What is being tested?
The trial is testing three different doses (30mg, 70mg, and 100mg) of Guselkumab—an anti-IL23 antibody—to assess its safety and how well it's tolerated in treating alcoholic liver disease.See study design
What are the potential side effects?
Potential side effects are not specified here but may include reactions typical for monoclonal antibodies such as infusion-related reactions, allergic responses, immune system changes that could affect organ function.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 21 or older with a BMI between 20 and 45.
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My liver is damaged.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not pregnant, breastfeeding, or have a positive pregnancy test.
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I have an autoimmune liver disease.
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I have a blood vessel disorder in my liver.
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I have cirrhosis confirmed by imaging or lab tests.
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I have never used guselkumab or similar medications, nor am I allergic to them.
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I have had an organ transplant, but not a cornea transplant.
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I have no active cancers except for treated skin cancer or any diagnosed in the last 5 years.
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I have signs of advanced liver disease like enlarged spleen or fluid in the abdomen.
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I need medication to help my heart pump more effectively.
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I have signs of high blood pressure in the liver, like fluid in the belly or swollen veins in my stomach or esophagus.
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I have had breast, prostate, or any cancer in the last 5 years.
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I am currently taking medications like chloroquine or paclitaxel.
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I have liver problems caused by medication.
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I have acute hepatitis A.
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I have active tuberculosis.
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I have had skin cancer in the past year.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~48 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 48 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Assess the safety and tolerability of Guselkumab

Trial Design

3Treatment groups
Experimental Treatment
Group I: Guselkumab 70 mgExperimental Treatment1 Intervention
Guselkumab administered by subcutaneous injection at Day 1 and Day 29
Group II: Guselkumab 30mgExperimental Treatment1 Intervention
Guselkumab administered by subcutaneous injection at Day 1 and Day 29
Group III: Guselkumab 100mgExperimental Treatment1 Intervention
Guselkumab administered by subcutaneous injection at Day 1 and Day 29

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Alcoholic Liver Disease (ALD) often target inflammation and immune responses, which are central to the disease's progression. Anti-IL23 antibodies, like the one being studied, work by inhibiting the IL-23 cytokine, a key player in the inflammatory process. This reduction in inflammation can help mitigate liver damage and improve liver function. Other treatments may include corticosteroids, which suppress the overall immune response, and antioxidants that reduce oxidative stress. These mechanisms are crucial for ALD patients as they directly address the inflammatory pathways that exacerbate liver injury, potentially slowing disease progression and improving outcomes.
Safety and Efficacy of Infliximab in Severe Alcoholic Hepatitis: A Systematic Review.

Find a Location

Who is running the clinical trial?

University of California, San DiegoLead Sponsor
1,135 Previous Clinical Trials
1,551,220 Total Patients Enrolled
Rohit LoombaPrincipal Investigator - University of California, San Diego
Regents Of The University Of California -Ucsd Physician Assoc, Regents of the University of California - UCSD Medical Group, UC San Diego Health System-Hillcrest, UCSD Medical Center-Hillcrest
4 Previous Clinical Trials
880 Total Patients Enrolled

Media Library

Guselkumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04736966 — Phase 1
Alcoholic Liver Disease Research Study Groups: Guselkumab 30mg, Guselkumab 70 mg, Guselkumab 100mg
Alcoholic Liver Disease Clinical Trial 2023: Guselkumab Highlights & Side Effects. Trial Name: NCT04736966 — Phase 1
Guselkumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04736966 — Phase 1
~6 spots leftby Jul 2025