Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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.

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, or hepatitis C virus antibody with detectable RNA at screening, consistent with active or chronic infection.
  • Known HIV infection or positivity on immunoassay.
  • History or presence of an abnormal ECG that, in the investigator's opinion, is clinically meaningful.
  • Known hypersensitivity or severe reaction to parsaclisib or its excipients.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Cohort 1
Parsaclisib at the protocol-defined dose for 12 weeks followed by extension period, with a dose-increase option at Week 6 for participants who fulfill dose increase criteria.
  • Drug: Parsaclisib
    Parsaclisib administered orally.
    Other names:
    • INCB050465
Experimental
Cohort 2
Parsaclisib at the protocol-defined dose for 12 weeks followed by extension period.
  • Drug: Parsaclisib
    Parsaclisib administered orally.
    Other names:
    • INCB050465

Recruiting Locations

Montefiore Medical Center Department Of Oncology
Bronx, New York 10467

More Details

Status
Recruiting
Sponsor
Incyte Corporation

Study Contact

Incyte Corporation Call Center (US)
1.855.463.3463
medinfo@incyte.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.