A Study of INCB050465 in Participants With Autoimmune Hemolytic Anemia

Completed · Phase 2

Conditions studied: Autoimmune Hemolytic Anemia

In brief

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.

Key facts

Study ID: NCT03538041
Run by: Incyte Corporation
People needed: 25
Starts: 2018-11-21
Expected to finish: 2024-04-02
Last updated by the study team: 2025-07-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

Georgetown University Hospital — Washington D.C., District of Columbia, United States
University of Minnesota — Minneapolis, Minnesota, United States
Washington University School of Medicine — St Louis, Missouri, United States
Weill Medical College of Cornell University — New York, New York, United States
Montefiore Medical Center — The Bronx, New York, United States
University Health System Inc., Dba the University of Tn Medical Center — Knoxville, Tennessee, United States
Allgemeines Krankenhaus Der Stadt Wien — Vienna, Austria
Centre Hospitalier Universitaire Henri Mondor — Créteil, France
Centre Hospitalier Regional Universitaire (Chru) de Lille — Lille, France
Fondazione Irccs Ca Granda Ospedale Maggiore — Milan, Italy
UNIVERSITï¿½ DI NAPOLI FEDERICO II — Naples, Italy
AZIENDA OSPEDALIERO UNIVERSITARIA MAGGIORE DELLA CARITï¿½ DI NOVARA — Novara, Italy

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.