A Study of INCB050465 in Participants With Autoimmune Hemolytic Anemia
NCT ID: NCT03538041
Last Updated: 2025-07-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
25 participants
INTERVENTIONAL
2018-11-21
2024-04-02
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Parsaclisib 1 mg QD
Parsaclisib at 1 milligram (mg) once daily (QD) for 12 weeks followed by extension period, with a dose-increase option (to 2.5 mg QD) at Week 6 for participants who fulfill dose increase criteria.
Parsaclisib
Parsaclisib administered orally.
Parsaclisib 2.5 mg QD
Parsaclisib at 2.5 mg QD for 12 weeks followed by extension period.
Parsaclisib
Parsaclisib administered orally.
Interventions
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Parsaclisib
Parsaclisib administered orally.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Incyte Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Kathleen Butler, MD
Role: STUDY_DIRECTOR
Incyte Corporation
Locations
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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
UNIVERSIT� DI NAPOLI FEDERICO II
Napoli, , Italy
AZIENDA OSPEDALIERO UNIVERSITARIA MAGGIORE DELLA CARIT� DI NOVARA
Novara, , Italy
Countries
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References
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Barcellini W, Pane F, Patriarca A, Murakhovskaya I, Terriou L, DeSancho MT, Hanna WT, Leopold L, Rappold E, Szeto K, Wei S, Jager U. Parsaclisib for the treatment of primary autoimmune hemolytic anemia: Results from a phase 2, open-label study. Am J Hematol. 2024 Dec;99(12):2313-2320. doi: 10.1002/ajh.27493. Epub 2024 Oct 22.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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Parsaclisib
Identifier Type: OTHER
Identifier Source: secondary_id
2017-003652-22
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
INCB 50465-206
Identifier Type: -
Identifier Source: org_study_id
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