Alcohol-associated HepatitisPhase 2ITAALDNCT07060638
Integrated Therapies for Alcohol Use in Alcohol-associated Liver Disease (ITAALD) Trial
A Phase 2 study testing IL-22, Prednisone and Acamprosate in people with Alcohol-associated Hepatitis, run by Samer Gawrieh at 6 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Alcohol-associated Hepatitis
- What is being tested?
- IL-22, Prednisone and Acamprosate
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 216 participants
- Where
- 6 sitesUnited States
- Study dates
- 27 Jan 2026to Dec 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18, <70
- MELD 20-35
- Definitive or probable diagnosis of sAH as defined by the NIAAA criteria4, 5 A. Onset of jaundice (defined as serum total bilirubin >3 mg/dL) within the prior 8 weeks B. Ongoing average consumption of > 40 gm (for females) and > 60 gm (for males) alcohol daily for 6 months or more with less than 8 weeks of abstinence before onset of jaundice; OR If, in the investigator's judgment, alcohol use may have been underreported, available clinical evidence-including collateral history, medical records, prior documentation of alcohol use, alcohol biomarkers such as PEth, or other relevant evidence-indicates that the participant met the protocol-defined alcohol consumption requirement within the 8 weeks before screening.
- AST > 50 IU/L, D. AST: ALT > 1.5 E. ALT and AST values < 400 IU/L F. Liver biopsy findings consistent with AH
- In patients with possible AH or AH with confounding factors such as possible ischemic hepatitis, possible DILI, uncertain history of alcohol use (e.g., patient denies excessive alcohol use), and atypical/abnormal laboratory tests (e.g., AST < 50 IU/L or > 400 IU/L, AST/ALT ratio < 1.5), antinuclear antibody > 1:160 or SMA > 1:80, a standard of care liver biopsy will be considered during current hospital admission to confirm AH and exclude competing etiologies.
- Females of childbearing (reproductive) potential must have a negative serum or urine pregnancy test at screening.
Who cannot join
- Active listing for liver transplantation before screening
- MELD score <20 or > 35
- Uncontrolled infection (persistent positive blood or other body fluid cultures despite 48 hours of antibiotic therapy)
- Progressive hemodynamic compromise requiring intravenous pressors
- Pneumonia as evidenced by clinical and/or radiological examination (will not perform radiology if not indicated by clinical exam)
- Renal failure defined by estimated GFR (CKD-EPI) <35 mL/min.
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- Clinically active C. diff infection
- Evidence of other liver diseases (such as autoimmune hepatitis, primary biliary cholangiopathy, primary sclerosing cholangitis, ischemic, sepsis- or drug-induced liver disease)
- History or presence of cancer (including hepatocellular carcinoma) other than non-melanoma skin cancer
- Prior exposure to systemic corticosteroid (glucocorticoid) or TNF-alpha inhibitors for more than 4 days within the previous 30 days prior to screening, specifically for the treatment of sAH.
- Clinically significant pancreatitis- abdominal pain, elevated lipase (> 3 X ULN), and at least edema of pancreas with fat-stranding on CT scan
- Active gastrointestinal bleeding defined as hematemesis or melena with a decrease in hemoglobin more than 2 g/dl in 24 hours due to gastrointestinal bleeding, or with a decrease in mean arterial BP to < 65 mmHg
- Significant concomitant medical illnesses (such as uncontrolled congestive heart failure or COPD or progressive multi-organ failure) as determined by the study investigator
- Uncontrolled mental illness as determined by the study investigator
- Uncontrolled HBV, HIV, or HCV infection with persistent viremia. However, subjects with controlled (undetectable viral load) HIV and HBV on viral suppressive therapies will be enrolled and subjects with history of HCV will be enrolled if they have evidence of SVR within one year prior to enrollment
- Active illicit opiates, cocaine, ketamine, or methamphetamine use in the last 30 days via patient report or medical chart review.
- Uncontrolled diabetes mellitus with A1c > 9
- Pregnancy or breastfeeding
- Known allergy or intolerance to therapeutic agents to be tested
- Unwillingness to stop alcohol use and to undergo AUD treatment
- Unwillingness to either abstain from sexual intercourse, or if sexually active, use a reliable method of birth control during the study and for at least 30 days after the last dose of the study medication. Examples of acceptable birth control methods include double barrier method such as condom and occlusive cap (diaphragm or cervical cap) with spermicidal foam/gel/film/cream/suppository; birth control pills, patches, injections, or implants; intrauterine device (IUD); vasectomy and tubal ligation.
- Participant has any condition or circumstance that adversely affects the participant, could cause noncompliance with treatment or visits, may impact the interpretation of clinical data, could cause bias, or may otherwise contraindicate the participant's participation in the study.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
United States6 sites, 6 recruiting
- Recruiting
Cleveland Clinic
Cleveland, Ohio, 44195
Srinivasan Dasarathy, MD
- Recruiting
University of Texas Southwestern Medical School
Dallas, Texas, 15260
Mack Mitchell, MD
- Recruiting
Indiana University
Indianapolis, Indiana, 46202
Raj Vuppalanchi, MD
- Recruiting
University of Louisville
Louisville, Kentucky, 40292
Ashwani Singal, MD
- Recruiting
Virginia Commonwealth University
Richmond, Virginia, 23284
Arun Sanyal, MD
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55902
Vijay Shah, MD
About this study
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.
Read the detailed description
Objectives:
- To determine whether interventions directed to treat AUD integrated with sAH therapies will improve a composite endpoint of alcohol and liver-related events at 6 months compared to usual care for AUD (primary endpoint).
- To compare 90-day survival in patients receiving F-652 with those receiving up to 28 days of prednisone using the Day-7 Lille score as a stopping rule (secondary endpoint).
- To compare one-year overall survival in patients receiving either IL-22 or prednisone with or without acamprosate (secondary endpoint).
Trial design and conduct
The Investigators will conduct a prospective, multicenter, sequentially randomized trial in 216 patients with sAH using a sequentially randomized design for proof of concept. The trial will assess whether integrated treatment of sAH and AUD reduces alcohol- and liver-related events and mortality.
The trial design resembles a 2X2 factorial study, but the AUD treatment assignment [acamprosate + motivational interviewing (MI) + motivational enhancement therapy (MET)] versus usual care (UC), defined as a brief intervention with advice not to drink alcohol-containing beverages and referral to a 12-step program, is done on Day 7 after the start of the sAH treatment. Only survivors of the first 7 days will be randomized to receive the AUD intervention or UC.
The study will be conducted at six clinical sites in the United States selected by the National Institute of Alcoholic Abuse and Alcoholism (NIAAA) and supported by a Data Coordinating Center at Indiana University (DCC). The DCC will also manage the biorepository.
The study will be conducted according to Good Clinical Practice (GCP) and in compliance with local, state, and federal regulatory requirements. Adverse events during the trial will be identified, recorded, assessed for causality, and reported in accordance with FDA guidance. In addition to general assessment, the investigators will specifically focus on (1) rates and types of infection as well as their severity, (2) potential development of drug-induced liver injury, (3) injection site reactions, and (4) hematological adverse events.
This study will be approved by an appropriately convened single IRB, Advarra, and will be monitored by an NIAAA-appointed Data and Safety Monitoring Board (DSMB). The Investigators will conduct this study under an Investigational New Drug (IND) application from the United States Food and Drug Administration (FDA).
It is anticipated that a centrally located investigational pharmacy at Indiana University will dispense the study medications to all participating sites under close coordination from the DCC. The study will provide the participants with F-652, prednisone, matching placebos, and acamprosate.
Duration of Trial by Phase Treatment phase: up to 6 months Follow-up phase: up to two years
Interventions to be tested F-652 vs. prednisone as treatment for sAH. AUD interventions (acamprosate + MI + MET) versus usual care for AUD treatment.
Group assignment:
The Investigators will sequentially randomize the study participants into four treatment groups.
On day 1, participants will be randomized to receive either F-652 or prednisone at a 1-to-1 ratio. Those randomized to receive F-652 will also receive a prednisone placebo; those randomized to receive prednisone will receive the F-652 placebo. Prednisone or prednisone placebo will be stopped if the Day-7 Lille score is >0.45.
On day 7, survivors will be randomized to receive either the AUD intervention (acamprosate + MI + MET) or usual care at a 1-to-1 ratio.
Block randomization will be used to ensure balanced group sizes in randomization.
So, there will be four treatment combinations:
ARM 1: 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.
ARM 2: F-652 on days 1 and 7 and matching placebo for prednisone for 28 days and usual care for AUD.
ARM 3: 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.
ARM 4: Prednisone for 28 days and matching placebo for F-652 on days 1 and 7 and usual care for AUD.
Distribution of study drug and placebo Participants or guardians will be instructed on drug timing and dose of these experimental treatments after discharge from the hospital. Study personnel will ensure participants and guardians are knowledgeable about the frequency and amount before the end of the study visit, and an instructional document will be provided.
- Conditions
- Alcohol-associated Hepatitis
- Being tested
- IL-22, Prednisone, Acamprosate, Prednisone placebo, IL-22 (F-652) Placebo
- Keywords
- Severe AH, AUD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IL-22Drug
Also called F-652
F-652 (IL-22) is a fusion protein of human IL-22 with IgG2 fragment, and has anti-inflammatory effects
PrednisoneDrug
Prednisone is an adrenal glucocorticoid with anti-inflammatory effects
AcamprosateDrug
Acamprosate is a propane-1 sulfonic acid with anti-ethanol dependency effects
Prednisone placeboDrug
Also called Placebo
Matching placebo
IL-22 (F-652) PlaceboDrug
Also called Placebo
Matching Placebo
Motivational Interviewing (MI)Behavioural
Also called Behavioral therapy
MI is an evidence-based counseling style to overcome ambivalence to treatment in AUD patients
Motivational Enhancement Therapy (MET)Behavioural
Also called Behavioral therapy
MET is an MI-based approach that includes 2-4 behavioral treatment sessions based on the Platform Treatment Manual
Usual CareBehavioural
defined as a brief intervention with advice not to drink alcohol-containing beverages and referral to a 12-step program
| Study group | Role | What they receive |
|---|---|---|
| IL-22 (F-652), Prednisone Placebo, Acamprosate, MI and MET | Active comparator | 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 Receives: Drug: IL-22; Drug: Acamprosate; Drug: Prednisone placebo; Behavioral: Motivational Interviewing (MI); Behavioral: Motivational Enhancement Therapy (MET) |
| IL-22 (F-652), Prednisone Placebo, and usual care | Active comparator | F-652 on days 1 and 7 and matching placebo for prednisone for 28 days and usual care for AUD. Receives: Drug: IL-22; Drug: Prednisone placebo; Behavioral: Usual Care |
| Prednisone, IL-22 (F-652) Placebo, Acamprosate, MI, and MET | Active comparator | 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 Receives: Drug: Prednisone; Drug: Acamprosate; Drug: IL-22 (F-652) Placebo; Behavioral: Motivational Interviewing (MI); Behavioral: Motivational Enhancement Therapy (MET) |
| Prednisone, IL-22 (F-652) Placebo, and usual care | Active comparator | Prednisone for 28 days and matching placebo for F-652 on days 1 and 7 and usual care for AUD. Receives: Drug: Prednisone; Drug: IL-22 (F-652) Placebo; Behavioral: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Death
Number (%) of participants who die from any cause
Measured: 6 months
Liver transplant
Number (%) of participants who receive liver transplant
Measured: 6 months
Ascites
Number (%) of participants with new onset of clinically detectable
Measured: 6 months
Hepatic encephalopathy
Number (%) of participants with hepatic encephalopathy ≥ New Haven grade 2
Measured: 6 months
Portal hypertensive bleeding
Number (%) of participants with gastroesophageal varices or portal gastropathy
Measured: 6 months
Liver-related hospital admission
Number (%) of participants with liver-related hospital admission for ascites, hepatic encephalopathy, infection, GI bleeding
Measured: 6 months
Increase in MELD score > 5 points
Number (%) of participants with increase in MELD score > 5 points
Measured: 6 months
Return to drinking
Number (%) of participants that return to drinking defined as <100% abstinence-using timeline follow back questionnaire
Measured: 6 months
Secondary outcomes (2)
Transplant-free survival
Time participants live without liver transplant
Measured: 30 days, 90 days, 180 days, 1 year, and 2 years
Overall Survival
Time participants live
Measured: 30 days, 90 days, 180 days, 1 year, and 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2025
- Study start27 Jan 2026
- Primary completionDec 2029 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol-associated HepatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 216 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samer Gawrieh
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor-investigator, Samer Gawrieh, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07060638
- Sponsor's protocol ID
- ITAALD
- Other IDs
- U24AA026969
- Acronym
- ITAALD
- Status last verified
- Jul 2026
- First submitted
- 10 Jun 2025
- Last updated
- 15 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrated Therapies for Alcohol Use in Alcohol-associated Liver Disease (ITAALD) Trial
- ClinicalTrials.gov ID
- NCT07060638
- Acronym / sponsor ID
- ITAALD / ITAALD
- Conditions
- Alcohol-associated Hepatitis
- Keywords
- Severe AH, AUD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 216 participants (estimated)
- Lead sponsor
- Samer GawriehUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 27 Jan 2026 (actual)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 11 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Objectives:
- To determine whether interventions directed to treat AUD integrated with sAH therapies will improve a composite endpoint of alcohol and liver-related events at 6 months compared to usual care for AUD (primary endpoint).
- To compare 90-day survival in patients receiving F-652 with those receiving up to 28 days of prednisone using the Day-7 Lille score as a stopping rule (secondary endpoint).
- To compare one-year overall survival in patients receiving either IL-22 or prednisone with or without acamprosate (secondary endpoint).
Trial design and conduct
The Investigators will conduct a prospective, multicenter, sequentially randomized trial in 216 patients with sAH using a sequentially randomized design for proof of concept. The trial will assess whether integrated treatment of sAH and AUD reduces alcohol- and liver-related events and mortality.
The trial design resembles a 2X2 factorial study, but the AUD treatment assignment [acamprosate + motivational interviewing (MI) + motivational enhancement therapy (MET)] versus usual care (UC), defined as a brief intervention with advice not to drink alcohol-containing beverages and referral to a 12-step program, is done on Day 7 after the start of the sAH treatment. Only survivors of the first 7 days will be randomized to receive the AUD intervention or UC.
The study will be conducted at six clinical sites in the United States selected by the National Institute of Alcoholic Abuse and Alcoholism (NIAAA) and supported by a Data Coordinating Center at Indiana University (DCC). The DCC will also manage the biorepository.
The study will be conducted according to Good Clinical Practice (GCP) and in compliance with local, state, and federal regulatory requirements. Adverse events during the trial will be identified, recorded, assessed for causality, and reported in accordance with FDA guidance. In addition to general assessment, the investigators will specifically focus on (1) rates and types of infection as well as their severity, (2) potential development of drug-induced liver injury, (3) injection site reactions, and (4) hematological adverse events.
This study will be approved by an appropriately convened single IRB, Advarra, and will be monitored by an NIAAA-appointed Data and Safety Monitoring Board (DSMB). The Investigators will conduct this study under an Investigational New Drug (IND) application from the United States Food and Drug Administration (FDA).
It is anticipated that a centrally located investigational pharmacy at Indiana University will dispense the study medications to all participating sites under close coordination from the DCC. The study will provide the participants with F-652, prednisone, matching placebos, and acamprosate.
Duration of Trial by Phase Treatment phase: up to 6 months Follow-up phase: up to two years
Interventions to be tested F-652 vs. prednisone as treatment for sAH. AUD interventions (acamprosate + MI + MET) versus usual care for AUD treatment.
Group assignment:
The Investigators will sequentially randomize the study participants into four treatment groups.
On day 1, participants will be randomized to receive either F-652 or prednisone at a 1-to-1 ratio. Those randomized to receive F-652 will also receive a prednisone placebo; those randomized to receive prednisone will receive the F-652 placebo. Prednisone or prednisone placebo will be stopped if the Day-7 Lille score is >0.45.
On day 7, survivors will be randomized to receive either the AUD intervention (acamprosate + MI + MET) or usual care at a 1-to-1 ratio.
Block randomization will be used to ensure balanced group sizes in randomization.
So, there will be four treatment combinations:
ARM 1: 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.
ARM 2: F-652 on days 1 and 7 and matching placebo for prednisone for 28 days and usual care for AUD.
ARM 3: 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.
ARM 4: Prednisone for 28 days and matching placebo for F-652 on days 1 and 7 and usual care for AUD.
Distribution of study drug and placebo Participants or guardians will be instructed on drug timing and dose of these experimental treatments after discharge from the hospital. Study personnel will ensure participants and guardians are knowledgeable about the frequency and amount before the end of the study visit, and an instructional document will be provided.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| IL-22 (F-652), Prednisone Placebo, Acamprosate, MI and MET | Active comparator | Drug: IL-22, Drug: Acamprosate, Drug: Prednisone placebo, Behavioral: Motivational Interviewing (MI), Behavioral: Motivational Enhancement Therapy (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 |
| IL-22 (F-652), Prednisone Placebo, and usual care | Active comparator | Drug: IL-22, Drug: Prednisone placebo, Behavioral: Usual CareF-652 on days 1 and 7 and matching placebo for prednisone for 28 days and usual care for AUD. |
| Prednisone, IL-22 (F-652) Placebo, Acamprosate, MI, and MET | Active comparator | Drug: Prednisone, Drug: Acamprosate, Drug: IL-22 (F-652) Placebo, Behavioral: Motivational Interviewing (MI), Behavioral: Motivational Enhancement Therapy (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 |
| Prednisone, IL-22 (F-652) Placebo, and usual care | Active comparator | Drug: Prednisone, Drug: IL-22 (F-652) Placebo, Behavioral: Usual CarePrednisone for 28 days and matching placebo for F-652 on days 1 and 7 and usual care for AUD. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥18, <70
- MELD 20-35
- Definitive or probable diagnosis of sAH as defined by the NIAAA criteria4, 5 A. Onset of jaundice (defined as serum total bilirubin >3 mg/dL) within the prior 8 weeks B. Ongoing average consumption of > 40 gm (for females) and > 60 gm (for males) alcohol daily for 6 months or more with less than 8 weeks of abstinence before onset of jaundice; OR If, in the investigator's judgment, alcohol use may have been underreported, available clinical evidence-including collateral history, medical records, prior documentation of alcohol use, alcohol biomarkers such as PEth, or other relevant evidence-indicates that the participant met the protocol-defined alcohol consumption requirement within the 8 weeks before screening.
- In patients with possible AH or AH with confounding factors such as possible ischemic hepatitis, possible DILI, uncertain history of alcohol use (e.g., patient denies excessive alcohol use), and atypical/abnormal laboratory tests (e.g., AST < 50 IU/L or > 400 IU/L, AST/ALT ratio < 1.5), antinuclear antibody > 1:160 or SMA > 1:80, a standard of care liver biopsy will be considered during current hospital admission to confirm AH and exclude competing etiologies.
- Females of childbearing (reproductive) potential must have a negative serum or urine pregnancy test at screening.
Key exclusion criteria (22 listed)
- Active listing for liver transplantation before screening
- MELD score <20 or > 35
- Uncontrolled infection (persistent positive blood or other body fluid cultures despite 48 hours of antibiotic therapy)
- Progressive hemodynamic compromise requiring intravenous pressors
- Pneumonia as evidenced by clinical and/or radiological examination (will not perform radiology if not indicated by clinical exam)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IL-22Also: F-652F-652 (IL-22) is a fusion protein of human IL-22 with IgG2 fragment, and has anti-inflammatory effects | Drug | IL-22 (F-652), Prednisone Placebo, Acamprosate, MI and MET, IL-22 (F-652), Prednisone Placebo, and usual care |
| PrednisonePrednisone is an adrenal glucocorticoid with anti-inflammatory effects | Drug | Prednisone, IL-22 (F-652) Placebo, Acamprosate, MI, and MET, Prednisone, IL-22 (F-652) Placebo, and usual care |
| AcamprosateAcamprosate is a propane-1 sulfonic acid with anti-ethanol dependency effects | Drug | IL-22 (F-652), Prednisone Placebo, Acamprosate, MI and MET, Prednisone, IL-22 (F-652) Placebo, Acamprosate, MI, and MET |
| Prednisone placeboAlso: PlaceboMatching placebo | Drug | IL-22 (F-652), Prednisone Placebo, Acamprosate, MI and MET, IL-22 (F-652), Prednisone Placebo, and usual care |
| IL-22 (F-652) PlaceboAlso: PlaceboMatching Placebo | Drug | Prednisone, IL-22 (F-652) Placebo, Acamprosate, MI, and MET, Prednisone, IL-22 (F-652) Placebo, and usual care |
| Motivational Interviewing (MI)Also: Behavioral therapyMI is an evidence-based counseling style to overcome ambivalence to treatment in AUD patients | Behavioural | IL-22 (F-652), Prednisone Placebo, Acamprosate, MI and MET, Prednisone, IL-22 (F-652) Placebo, Acamprosate, MI, and MET |
| Motivational Enhancement Therapy (MET)Also: Behavioral therapyMET is an MI-based approach that includes 2-4 behavioral treatment sessions based on the Platform Treatment Manual | Behavioural | IL-22 (F-652), Prednisone Placebo, Acamprosate, MI and MET, Prednisone, IL-22 (F-652) Placebo, Acamprosate, MI, and MET |
| Usual Caredefined as a brief intervention with advice not to drink alcohol-containing beverages and referral to a 12-step program | Behavioural | IL-22 (F-652), Prednisone Placebo, and usual care, Prednisone, IL-22 (F-652) Placebo, and usual care |
Primary outcome
Death
Time frame: 6 months
Number (%) of participants who die from any cause
Liver transplant
Time frame: 6 months
Number (%) of participants who receive liver transplant
Ascites
Time frame: 6 months
Number (%) of participants with new onset of clinically detectable
Hepatic encephalopathy
Time frame: 6 months
Number (%) of participants with hepatic encephalopathy ≥ New Haven grade 2
Portal hypertensive bleeding
Time frame: 6 months
Number (%) of participants with gastroesophageal varices or portal gastropathy
Liver-related hospital admission
Time frame: 6 months
Number (%) of participants with liver-related hospital admission for ascites, hepatic encephalopathy, infection, GI bleeding
Increase in MELD score > 5 points
Time frame: 6 months
Number (%) of participants with increase in MELD score > 5 points
Return to drinking
Time frame: 6 months
Number (%) of participants that return to drinking defined as <100% abstinence-using timeline follow back questionnaire
2 secondary outcomes
Transplant-free survival
Time frame: 30 days, 90 days, 180 days, 1 year, and 2 years
Overall Survival
Time frame: 30 days, 90 days, 180 days, 1 year, and 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing IL-22, Prednisone and Acamprosate in people with Alcohol-associated Hepatitis, run by Samer Gawrieh at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Savannah Yarnelle (3172786424, samussel@iu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Death (time frame: 6 months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2026.