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:
Eudra ID:
N/A
Sponsor:
Incyte Corporation
Collaborator:
Novartis Pharmaceuticals
Study Contact Information:
Study Complete
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)
PRODUCT
COLLABORATORS
Novartis Pharmaceuticals
DATE
Oct 2010 - Jan 2014
TYPE
Interventional
PHASE
Phase 3
SEX
Female & Male
AGE
18+ years
ACCEPTS HEALTHY VOLUNTEERS
No
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
Clinical Study Locations
Location
Status
Location
Birmingham, AL, US
Status
Active, not recruiting
Location
Scottsdale, AZ, US
Status
Active, not recruiting
Location
Pomona, CA, US
Status
Active, not recruiting
Location
Sacramento, CA, US
Status
Active, not recruiting
Location
San Diego, California, US
Status
Active, not recruiting
Location
Bridgeport, CT, US
Status
Active, not recruiting
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