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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
Male or female patients 21 years of age or older with BMI ≥ 20 to ≤ 45 kg/m2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 48 weeks
Awards & highlights

Study 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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I am 21 or older with a BMI between 20 and 45.
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My liver is damaged.

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

Find a Location

Who is running the clinical trial?

University of California, San DiegoLead Sponsor
1,117 Previous Clinical Trials
1,520,264 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has a similar trial ever been conducted before?

"Since its initial evaluation in 2018, which was conducted by Janssen Research & Development, LLC and included 1,406 participants, Guselkumab 100mg has been subject to further exploration. Subsequently receiving approval for Phase 2 & 3 trials the drug is now being studied across 57 countries with 19 active evaluations taking place in 286 cities worldwide."

Answered by AI

Has Guselkumab 100mg previously been assessed in any other clinical experiments?

"Currently, 19 trials of Guselkumab 100mg are active. 7 of these clinical studies have advanced to the third phase. While much research is being done in Milan and Kansas, there are a total 2732 locations conducting experiments with this drug."

Answered by AI

Is Guselkumab 100mg considered to be a safe therapeutic option?

"Guselkumab 100mg's safety profile is only partially known, so it was rated a 1 on our internal scale. This makes sense considering that this experimental drug remains in its initial assessment stage."

Answered by AI

Is this experimentation actively accepting new participants?

"Affirmative. According to information obtained from clinicaltrials.gov, this medical study is actively seeking participants and has been recruiting since March 3rd 2021. The research team aims to enroll 24 patients at a single location."

Answered by AI

What is the estimated sample size for this experimental research?

"Affirmative. According to the information on clinicaltrials.gov, this medical trial is in recruitment mode. Originally posted on March 3rd 2021 and last updated on May 3rd 2021, it requires 24 participants from one site only."

Answered by AI
~0 spots leftby Mar 2024