Study of the Efficacy and Safety of Parsaclisib in Participants With Primary Warm Autoimmune Hemolytic Anemia

• Status: Not yet recruiting
• Trial end date: 2024-06-04
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the efficacy and safety of parsclisib compared with placebo in participants with Primary Warm Autoimmune Hemolytic Anemia (wAIHA),

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Incyte Corporation

Criteria

Inclusion Criteria:

• Diagnosis of primary warm AIHA.

• Participants who have at least 1 unsuccessful prior therapy for warm AIHA or unable to receive or tolerate other therapies.

• Hemoglobin ≥ 7 to < 10 g/dL with symptoms of anemia at screening.

• FACIT-F score ≤ 43 at screening.

• Willingness to avoid pregnancy or fathering children.

• Willingness to receive PJP prophylaxis.

• Further inclusion criteria apply.

Exclusion Criteria:

• Women who are pregnant, breastfeeding or who are planning a pregnancy.

• Diagnosis of other types of AIHA (CAD, cold agglutinin syndrome, mixed-type AIHA or paroxysmal cold hemoglobinuria).

• Secondary warm AIHA from any cause.

• Splenectomy less than 3 months before randomization.

• Participants with a history or ongoing significant illness as assessed by the investigator.

• Participants with a current of medical history of a malignancy within the past 5 years except basal or squamous cell skin cancer that has been removed and considered cured, or superficial bladder cancer, prostate intraepithelial neoplasm, carcinoma in situ of the cervix, or other noninvasive or indolent malignancy.

• Participants know to be infected with HIV, Hepatitis B, or hepatitis C.

• Chronic or current active infectious disease requiring systemic antibiotics, antifungal, or antiviral treatment or exposure to a live vaccine.

• Participants with laboratory values outside of the protocol defined ranges.

• Further exclusion criteria apply.