Autoimmune hemolytic anemia

A Study of INCB050465 in Participants With Autoimmune Hemolytic Anemia

Incyte Study ID:
INCB 50465-206
CT.gov ID:
NCT03538041
View Results Summary
Eudra ID:
N/A
Sponsor:
Incyte Corporation
Collaborator:
N/A
Study Contact Information:
1.855.463.3463 or [email protected]
Study Complete
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Results Available

Protocol
Available Languages: English
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Statistical Analysis Plan (SAP)
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Clinical Study Purpose

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.

Clinical Study Summary

MEDICAL CONDITION(S)
  • Autoimmune hemolytic anemia
    • PRODUCT
  • Drug: Parsaclisib
    • COLLABORATORS
    N/A
    DATE
    Nov 2018 - Aug 2021
    TYPE
    Interventional
    PHASE
    Phase 2
    SEX
    Female & Male
    AGE
    18+ years
    ACCEPTS HEALTHY VOLUNTEERS
    No

    Clinical Study Locations

    Name
    Contact Us
    Name
    GEORGETOWN UNIVERSITY HOSPITAL
    Washington, District of Columbia, US, 20007
    Name
    UNIVERSITY OF MINNESOTA
    MINNEAPOLIS, MN, US, 55455
    Name
    WASHINGTON UNIVERSITY SCHOOL OF MEDICINE
    SAINT LOUIS, MO, US, 63110
    Name
    MONTEFIORE MEDICAL CENTER
    BRONX, NY, US, 10467
    Name
    CENTRE HOSPITALIER REGIONAL UNIVERSITAIRE (CHRU) DE LILLE
    LILLE, France, 59037
    Name
    FONDAZIONE IRCCS CA GRANDA OSPEDALE MAGGIORE
    MILAN, Italy, 20122

    Key Inclusion and Exclusion Criteria

    Inclusion Criteria

    • 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.

    Exclusion Criteria

    • Pregnant or breastfeeding women.
    • Concurrent conditions and history of other protocol-specified diseases.

    Protocol Summary

    Incyte Study ID:
    INCB 50465-206
    Primary Purpose:
    Treatment
    Allocation:
    Non-randomized
    Study Design:
    Parallel Assignment
    Masking:
    None (Open Label)
    Interventions:
    Drug
    Enrollment:
    25
    Primary Outcome
    Open

    Proportion of participants attaining a complete response (CR)

    Timeframe: Week 6 to Week 12

    Proportion of participants attaining a partial response (PR)

    Timeframe: From Baseline to Week 6 to Week 12

    Number of participants with a treatment-emergent adverse event (TEAE)

    Timeframe: Up to 28 weeks

    Secondary Outcome
    Open

    Proportion of participants attaining a CR during post baseline visits

    Timeframe: Up to 28 weeks

    Proportion of participants attaining a PR during post baseline visits

    Timeframe: From Baseline up to 28 weeks

    Proportion of participants attaining an increase in hemoglobin from baseline

    Timeframe: From Baseline up to 28 weeks

    Change from baseline of hemoglobin

    Timeframe: From Baseline up to 28 weeks

    Proportion of participants requiring transfusions

    Timeframe: From Baseline up to 28 weeks

    Proportion of participants who achieve normalization of hemolytic markers

    Timeframe: Up to 28 weeks

    Change of daily usage of prednisone

    Timeframe: From Baseline up to 28 weeks

    Change from baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) sub-scale questionnaire

    Timeframe: From Baseline up to 28 weeks