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

    Not Recruiting
  • End date
    Apr 22, 2027
  • participants needed
  • sponsor
    Incyte Corporation
Updated on 29 July 2023


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),


Prospective participants must have primary wAIHA as well as other protocol-defined criteria. After participants have been determined to be eligible for the study, they will be randomized to 2:1, with stratification factor of corticosteroid dose and hemoglobin (Hgb <9 g/dL or ≥ 9 g/dL). Once a participant has completed the week 24 assessments in the double-blind period, the participant will have the opportunity to receive parsaclisib in the open-label treatment which will last up to another 24 weeks. Participants may then continue to receive parsaclisib in a long-term extension period.

Condition Warm Autoimmune Hemolytic Anemia (wAIHA)
Treatment Placebo, parsaclisinib
Clinical Study IdentifierNCT05073458
SponsorIncyte Corporation
Last Modified on29 July 2023

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