Safety of Itacitinib in Combination With Corticosteroids for Treatment of Steroid-Naive Acute Graft-Versus-Host Disease in Japanese Subjects

Exclusion Criteria

• •Has received more than 1 allo-HSCT.
• •Has received more than 2 days of systemic corticosteroids for aGVHD.
• •Presence of GVHD overlap syndrome.
• •Presence of an active uncontrolled infection (defined as hemodynamic instability attributable to sepsis or new symptoms, worsening physical signs, or radiographic findings attributable to infection; persisting fever without signs or symptoms will not be interpreted as an active uncontrolled infection).
• •Known human immunodeficiency virus infection.
• •Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection that requires treatment or at risk for HBV reactivation. For subjects with negative HBsAg and positive total hepatitis B core antibody and for subjects who are positive for HCV antibody, HBV DNA and HCV RNA must be undetectable upon testing.
• •Evidence of relapsed primary disease or having been treated for relapse after the allo-HSCT was performed.
• •Any corticosteroid therapy (for indication other than GVHD) at doses \> 1 mg/kg per day methylprednisolone or equivalent within 7 days of enrollment.
• •Severe organ dysfunction unrelated to underlying GVHD, including the following:
• •* Cholestatic disorders or unresolved veno-occlusive disease of the liver.
• •* Clinically significant or uncontrolled cardiac disease.
• •* Clinically significant respiratory disease that requires mechanical ventilation support or 50% oxygen.
• •Serum creatinine \> 2.0 mg/dL or creatinine clearance \< 40 mL/min measured or calculated by Cockroft-Gault equation
• •Received Janus kinase (JAK) inhibitor therapy after allo-HSCT for any indication. Treatment with a JAK inhibitor before allo-HSCT is permitted.
• •Known allergies, hypersensitivity, or intolerance to any of the study medications, excipients, or similar compounds.