Integrated Therapies for Alcohol Use in Alcohol-associated Liver Disease (ITAALD) Trial

Summary

This is a multicenter, randomized, double-blinded, placebo-controlled trial focused on the treatment of severe alcohol-associated hepatitis (sAH) and alcohol use disorder (AUD).

The primary purpose of the study is to determine whether subjects receiving sAH therapy in addition to AUD treatments will have better alcohol and liver-related outcomes at 6 months compared to sAH therapy plus usual care for AUD. Patients assigned to the AUD treatment will receive Acamprosate and counseling whereas those assigned to AUD standard care will receive brief advice and referral to a 12-step program.

The secondary purpose of the study is to determine if F-652 is safe and effective in treating sAH when compared to prednisone. Subjects will receive F-652 on days 1 and 7 or prednisone for 28 days. Outcomes will be measured by overall survival at 90 days.

Conditions

• Alcohol-associated Hepatitis

Interventions

DRUG

IL-22

F-652 (IL-22) is a fusion protein of human IL-22 with IgG2 fragment, and has anti-inflammatory effects

DRUG

Prednisone

Prednisone is an adrenal glucocorticoid with anti-inflammatory effects

DRUG

Acamprosate

Acamprosate is a propane-1 sulfonic acid with anti-ethanol dependency effects

DRUG

Prednisone placebo

Matching placebo

DRUG

IL-22 (F-652) Placebo

Matching Placebo

BEHAVIORAL

Motivational Interviewing (MI)

MI is an evidence-based counseling style to overcome ambivalence to treatment in AUD patients

BEHAVIORAL

Motivational Enhancement Therapy (MET)

MET is an MI-based approach that includes 2-4 behavioral treatment sessions based on the Platform Treatment Manual

BEHAVIORAL

Usual Care

defined as a brief intervention with advice not to drink alcohol-containing beverages and referral to a 12-step program

Sponsors & Collaborators

• National Institute on Alcohol Abuse and Alcoholism (NIAAA)

  collaborator NIH

• Samer Gawrieh

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-01-27

Primary Completion

2029-12-31

Completion

2031-06-30

FDA Drug

Yes

Countries

• United States

Study Locations