A Phase 2, Open-Label Study of INCB050465 in Participants With Autoimmune Hemolytic Anemia
The purpose of this study is to evaluate the safety and efficacy of parsaclisib administered orally to participants with autoimmune hemolytic anemia (AIHA) who have decreased hemoglobin and evidence of ongoing hemolysis that requires treatment intervention.
• Diagnosis of AIHA based on the presence of hemolytic anemia and serological evidence of anti-erythrocyte antibodies, detectable by the direct antiglobulin test.
• Participants who have disease progression after treatment with standard therapies that are known to confer clinical benefit, or who are intolerant to treatment, or who refuse standard treatment. There is no limit to the number of prior treatment regimens.
• Hemoglobin 7 to 10 g/dL.
• No evidence of a lymphoproliferative malignancy or other autoimmune-related underlying conditions.
• Eastern Cooperative Oncology Group performance status of 0 to 2.
• Willingness to avoid pregnancy or fathering children.