Study of Itacitinib in Combination With Corticosteroids for the Treatment of Acute GVHD

Exclusion Criteria

• •Has received more than 1 hematopoietic stem cell transplantation.
• •Has progressed on more than 2 prior treatment regimens for acute GVHD.
• •Presence of an active uncontrolled infection.
• •Subjects with relapsed primary disease, or subjects who have been treated for relapse after the allogeneic hematopoietic stem-cell transplantation (allo-HSCT) was performed.
• •Inadequate recovery from toxicity and/or complications from the prior allo-HSCT.
• •Any corticosteroid therapy (for indications other than GVHD) at doses \> 1 mg/kg per day methylprednisolone or equivalent within 7 days of randomization.
• •Previously received JAK inhibitor therapy for any indication.