Polycythemia Vera (PV)

Study of Efficacy and Safety in Polycythemia vera subjects who are resistant to or intolerant of hydroxyurea: JAK inhibitor INC424 (INCB018424) tablets versus best available care: (The RESPONSE Trial)

Incyte Study ID:
CINC424B2301
CT.gov ID:
NCT01243944
View Results Summary
Eudra ID:
N/A
Sponsor:
Incyte Corporation
Collaborator:
Novartis Pharmaceuticals
Study Contact Information:
1.855.463.3463
Study Complete
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Clinical Study Purpose

This pivotal phase III trial (CINC424B2301) is designed to compare the efficacy and safety of ruxolitinib (INC424) to Best Available Therapy (BAT) in participants with polycythemia vera (PV) who are resistant to or intolerant of hydroxyurea (HU).

Clinical Study Summary

MEDICAL CONDITION(S)
  • Polycythemia Vera (PV)
    • PRODUCT
  • Drug: ruxolitinib tablets
    • COLLABORATORS
    Novartis Pharmaceuticals
    DATE
    Oct 2010 - Jan 2014
    TYPE
    Interventional
    PHASE
    Phase 3
    SEX
    Female & Male
    AGE
    18+ years
    ACCEPTS HEALTHY VOLUNTEERS
    No

    Clinical Study Locations

    Name
    Contact Us
    Name
    Birmingham, AL, US
    Name
    Scottsdale, AZ, US
    Name
    Pomona, CA, US
    Name
    Sacramento, CA, US
    Name
    San Diego, California, US
    Name
    Bridgeport, CT, US

    Key Inclusion and Exclusion Criteria

    Inclusion Criteria

    • Participants diagnosed with PV for at least 24 weeks prior to screening according to the 2008 World Health Organization criteria
    • Participants resistant to or intolerant of hydroxyurea

    Exclusion Criteria

    • Women who are pregnant or nursing
    • Participants with inadequate liver or renal function

    Protocol Summary

    Incyte Study ID:
    CINC424B2301
    Primary Purpose:
    Treatment
    Allocation:
    Randomized
    Study Design:
    Parallel Assignment
    Masking:
    None (Open Label)
    Interventions:
    Drug
    Enrollment:
    222
    Primary Outcome
    Open
    Secondary Outcome
    Open