Status:
WITHDRAWN
Apremilast for Chronic Plaque Psoriasis (CPP) Patients Who Have Failed One Course of Biologic Therapy
Lead Sponsor:
Duke University
Conditions:
Chronic Plaque Psoriasis
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
This is a Phase II, open label, investigator-initiated study to be done at Duke University Medical Center to treat adult patients (ages 18-80) with chronic plaque psoriasis who have failed Biologic Th...
Detailed Description
Data Analysis Data will be analyzed and reported after all subjects have completed follow-up phase of study. All subsequent data collected will be analyzed and reported in a follow-up clinical report....
Eligibility Criteria
Inclusion
- Subjects 18-80 yrs diagnosed with moderate-to-severe chronic plaque psoriasis with a PGA of 3 or greater and require systemic therapy
- Must have received a biologic therapy for CPP and did not achieve a PGA of 'almost clear' or 'clear'
- Must meet lab criteria per Pg 20-21 of protocol
- All subjects must follow contraceptive measures as described in protocol, Pg 21.
Exclusion
- Abnormal Chest x-ray
- Significant abnormality of ECG
- Positive HIV Ab, Hepatitis B \& C
- Subjects with erythrodermic, pustular or guttate psoriasis are ineligible
- Serious local infection or systemic infection, or tuberculosis within 3 mos of first dose of apremilast
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2012
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01200264
Start Date
September 1 2010
End Date
September 1 2012
Last Update
July 15 2014
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Duke University Medical Center
Durham, North Carolina, United States, 27710