What side effects are associated with this type of intervention?

Common treatments for Alcoholic Liver Disease (ALD) include corticosteroids, pentoxifylline, and abstinence from alcohol. Corticosteroids can cause side effects such as increased susceptibility to infections, weight gain, and osteoporosis. Pentoxifylline may lead to gastrointestinal disturbances, dizziness, and headaches. For treatments similar to anti-IL-23 antibodies, such as guselkumab, side effects observed in other conditions include infections, injection site reactions, and potential allergic reactions. It is important to consult with a healthcare provider to understand the specific risks and benefits of these treatments.

What prior FDA approvals exist?

Currently, there are no FDA-approved treatments specifically targeting IL-23 for Alcoholic Liver Disease. The standard treatments for Alcoholic Liver Disease primarily focus on lifestyle changes, such as abstinence from alcohol, nutritional support, and managing complications. Medications like corticosteroids and pentoxifylline are sometimes used to reduce inflammation and improve liver function. The ongoing Phase I clinical trial for guselkumab, an anti-IL23 antibody, represents a novel approach by targeting the IL-23 cytokine to reduce inflammation in patients with Alcoholic Liver Disease.

What other types of research exist?

Promising novel alternatives to Anti-IL23 Antibody for treating Alcoholic Liver Disease in 2024 could include therapies targeting other inflammatory pathways, such as anti-IL-5 therapies (e.g., benralizumab, mepolizumab, reslizumab) which have shown efficacy in other inflammatory conditions. Additionally, direct-acting antivirals like daclatasvir and sofosbuvir, although primarily for hepatitis C, demonstrate the potential for targeting liver inflammation and could be considered for further research in alcoholic liver disease.

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Monoclonal Antibodies

Guselkumab for Alcoholic Liver Disease

Phase 1

Waitlist Available

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

All Individual Drugs Already Approved

No Placebo-Only Group

Summary

This trial is testing a drug called guselkumab in patients with alcoholic liver disease. The goal is to see if it is safe and can reduce liver inflammation. The study will start with low doses and gradually increase to find the safest dose. Guselkumab has shown benefits in treating other inflammatory conditions.

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 48 weeks

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Assess the safety and tolerability of Guselkumab

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Guselkumab

FDA approved

Guselkumab

FDA approved

Guselkumab

FDA approved

0 / 18Eligibility criteria met

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

1,187 Previous Clinical Trials

1,576,762 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