CompletedPhase 1

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

United States13 participantsStarted 2021-03-03

Plain-language 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

Who can participate

Age range

21 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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.

Exclusion criteria

. History or evidence of other or concomitant cause(s) of liver disease as a result of:
. Autoimmune liver disease

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Assess the safety and tolerability of Guselkumab

Timeframe: 48 Weeks

Trial details

NCT IDNCT04736966

SponsorUniversity of California, San Diego

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-03-31

View on ClinicalTrials.gov More Alcoholic Liver Disease trials