Selonsertib in Combination With Prednisolone Versus Prednisolone Alone in Participants With Severe Alcoholic Hepatitis (AH)

Key Inclusion Criteria:

- Willing and able to give informed consent prior to any study specific procedures being
performed. In individuals with hepatic encephalopathy (HE) which may impair
decision-making, consent will be obtained per hospital procedures (eg, by Legally
Authorized Representative)

- Clinical diagnosis of severe AH

- Maddrey's Discriminant Function (DF) ≥ 32 at screening

Key Exclusion Criteria:

- Pregnant or lactating females;

- Other causes of liver disease including chronic hepatitis B (hepatitis B surface
antigen [HBsAg] positive), chronic hepatitis C (HCV RNA positive), acetaminophen
hepatotoxicity, biliary obstruction, and autoimmune liver disease;

- Serum aspartate aminotransferase (AST) >400 U/L or alanine aminotransferase (ALT) >300
U/L;

- Model for End Stage Liver Disease (MELD) >30 at screening;

- Maddrey's DF >60 at screening;

- Grade 4 Hepatic Encephalopathy (HE) by West Haven criteria;

- Concomitant or previous history of hepatocellular carcinoma;

- History of liver transplantation;

- HIV Ab positive;

- Clinical suspicion of pneumonia;

- Uncontrolled sepsis;

- Uncontrolled gastrointestinal (GI) bleeding or controlled GI bleeding within 7 days of
screening that was associated with shock or required transfusion of more than 3 units
of blood;

- Type 1 hepatorenal syndrome (HRS) or renal failure defined as a serum creatinine >221
μmol/L (>2.5 mg/dL) or the requirement for renal replacement therapy;

- Individuals dependent on inotropic (eg, epinephrine or norepinephrine) or ventilatory
support (ie, endotracheal intubation or positive-pressure ventilation);

- Portal vein thrombosis;

- Acute pancreatitis;

- Cessation of alcohol consumption for more than 2 months before Baseline/ Day 1

Note: Other protocol defined Inclusion/ Exclusion criteria may apply.