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

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Warm Autoimmune Hemolytic Anemia (wAIHA)

In brief

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

Key facts

Study ID

NCT05073458

Run by

Incyte Corporation

People needed

13

Starts

2022-03-15

Expected to finish

2024-04-29

Last updated by the study team

2025-11-03

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 ≥ 6.5 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.

You may not qualify if…

• 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 or diagnosis of Evans syndrome.
• 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.

Where it is running

• Investigative Site US004 — Whittier, California, United States
• Investigative Site US006 — Miami, Florida, United States
• Investigative Site US012 — Indianapolis, Indiana, United States
• Investigative Site US007 — The Bronx, New York, United States
• Investigative Site US002 — The Bronx, New York, United States
• Investigative Site US003 — Greenville, North Carolina, United States
• Investigative Site US009 — Canton, Ohio, United States
• Investigative Site US010 — Easton, Pennsylvania, United States
• Investigative Site US001 — Knoxville, Tennessee, United States
• Investigative Site AT002 — Salzburg CET, Austria
• Investigative Site AT001 — Vienna, Austria
• Investigative Site BE001 — La Louvière, Belgium
• Investigative Site BE002 — Liège, Belgium
• Investigative Site CA001 — Edmonton, Alberta, Canada
• Investigative Site FR002 — Lille, France
• Investigative Site FR003 — Marseille, France
• Investigative Site FR001 — Paris, France
• Investigative Site DE001 — Essen, Germany
• Investigative Site DE002 — Ulm, Germany
• Investigative Site IL002 — Haifa, Israel
• Investigative Site IL001 — Nahariya, Israel
• Investigative Site IT003 — Florence, Italy
• Investigative Site IT002 — Milan, Italy
• Investigative Site IT001 — Novara, Italy
• Investigative Site US005 — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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