A Study of INCB050465 in Participants With Autoimmune Hemolytic Anemia

Inclusion Criteria:

• Diagnosis of AIHA based on the presence of hemolytic anemia and serological evidenceof anti-erythrocyte antibodies, detectable by the direct antiglobulin test.

• Participants who have disease progression after treatment with standard therapiesthat are known to confer clinical benefit, or who are intolerant to treatment, orwho refuse standard treatment. There is no limit to the number of prior treatmentregimens.

• Hemoglobin 7 to 10 g/dL.

• No evidence of a lymphoproliferative malignancy or other autoimmune-relatedunderlying conditions.

• Eastern Cooperative Oncology Group performance status of 0 to 2.

• Willingness to avoid pregnancy or fathering children.

Exclusion Criteria:

• Pregnant or breastfeeding women.

• Concurrent conditions and history of other protocol-specified diseases.

• ANC < 1.5 × 10^9/L.

• Platelet count < 100 × 10^9/L.

• Severely impaired liver function.

• Impaired renal function with estimated creatinine clearance less than 45 mL/min.

• Anti-phospholipid antibodies positive or elevated anti-streptolysin antibodies.

• Positive serology test results for hepatitis B surface antigen or core antibody, orhepatitis C virus antibody with detectable RNA at screening, consistent with activeor chronic infection.

• Known HIV infection or positivity on immunoassay.

• History or presence of an abnormal ECG that, in the investigator's opinion, isclinically meaningful.

• Known hypersensitivity or severe reaction to parsaclisib or its excipients.