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

Conditions

• Alcohol-associated Hepatitis

Eligibility Criteria

Sex

ALL

Age

18 Years - 70 Years

Healthy Volunteers

Not accepted

Interventions

• IL-22 — DRUG
  F-652 (IL-22) is a fusion protein of human IL-22 with IgG2 fragment, and has anti-inflammatory effects
• Prednisone — DRUG
  Prednisone is an adrenal glucocorticoid with anti-inflammatory effects
• Acamprosate — DRUG
  Acamprosate is a propane-1 sulfonic acid with anti-ethanol dependency effects
• Prednisone placebo — DRUG
  Matching placebo
• IL-22 (F-652) Placebo — DRUG
  Matching Placebo
• Motivational Interviewing (MI) — BEHAVIORAL
  MI is an evidence-based counseling style to overcome ambivalence to treatment in AUD patients
• Motivational Enhancement Therapy (MET) — BEHAVIORAL
  MET is an MI-based approach that includes 2-4 behavioral treatment sessions based on the Platform Treatment Manual
• Usual Care — BEHAVIORAL
  defined as a brief intervention with advice not to drink alcohol-containing beverages and referral to a 12-step program

Study Details

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.

Key Dates

Start date

Jan 27, 2026

Status verified

Jun 2026

Primary completion

Dec 31, 2028

Completion

Jun 30, 2029

Study Design

Enrollment

216 participants (estimated)

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Active Comparator: IL-22 (F-652), Prednisone Placebo, Acamprosate, MI and MET
  F-652 on days 1 and 7 and matching placebos for prednisone for 28 days and acamprosate for 6 months. MI will be delivered during the hospitalization; MET sessions will be delivered in the first 3 months
• Active Comparator: IL-22 (F-652), Prednisone Placebo, and usual care
  F-652 on days 1 and 7 and matching placebo for prednisone for 28 days and usual care for AUD.
• Active Comparator: Prednisone, IL-22 (F-652) Placebo, Acamprosate, MI, and MET
  Prednisone for 28 days and matching placebos for F-652 on days 1 and 7 and acamprosate for 6 months. MI will be delivered during the hospitalization; MET sessions will be delivered in the first 3 months
• Active Comparator: Prednisone, IL-22 (F-652) Placebo, and usual care
  Prednisone for 28 days and matching placebo for F-652 on days 1 and 7 and usual care for AUD.

Primary Outcome Measure

Death [ Time Frame: 6 months ]

Central Contacts

• Savannah Yarnelle
  3172786424
  [email protected]

Locations (6)

Find similar trials in Indianapolis, IN

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