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

  • STATUS
    Recruiting
  • End date
    Apr 22, 2027
  • participants needed
    100
  • sponsor
    Incyte Corporation
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Updated on 11 November 2022
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Summary

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),

Description

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.

Details
Condition Warm Autoimmune Hemolytic Anemia (wAIHA)
Treatment Placebo, parsaclisinib
Clinical Study IdentifierNCT05073458
SponsorIncyte Corporation
Last Modified on11 November 2022

Eligibility

 Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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