Study of the Efficacy and Safety of Parsaclisib in Participants with Primary Warm wAIHA

• Research type

  Research Study

• Full title

  A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Parsaclisib in Participants with Primary Warm Autoimmune Hemolytic Anemia (PATHWAY)

• IRAS ID

  1004495

• Contact name

  Judith Magner

• Contact email

  jmagner@incyte.com

• Sponsor organisation

  Incyte Biosciences

• Eudract number

  2021-002844-66

• ISRCTN Number

  ISRCTN14903256

• Clinicaltrials.gov Identifier

  NCT05073458

• Research summary

  Research Summary
  primary warm autoimmune hemolytic anaemia (wAIHA) is a rare acquired condition where your body attacks its own red blood cells.
  The purpose of this Study is to compare the effects and safety of parsaclisib versus placebo in people with wAIHA.
  Approximately 100 adults from all over the world will participate in this Study.
  Participants will be in this study for a total of 15 months from Screening to be able to participate in a 24 week Extension Period and the final 12 week Follow-up Period.

  Summary of Results
  A summary of results will be submitted to ClinicalTrials.gov on April 2025 (https://clinicaltrials.gov/study/NCT05073458)

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  22/NW/0383

• Date of REC Opinion

  1 Feb 2023

• REC opinion

  Further Information Favourable Opinion