Status:
COMPLETED
Safety Study of Clinical and Immune Effects of Phosphodiesterase 4 (PDE-4) Inhibitor in Cutaneous Lupus Patients
Lead Sponsor:
NYU Langone Health
Collaborating Sponsors:
Celgene Corporation
Conditions:
Discoid Lupus Erythematosus
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this study is to determine the clinical and immunological effects of the phosphodiesterase type 4 inhibitor, CC-10004, on skin inflammation associated with cutaneous lupus erythematosus...
Detailed Description
Discoid cutaneous lupus is the most common cutaneous manifestation of lupus erythematosus, a chronic, immune mediated disease of unknown etiology. The immune processes underlying cutaneous lupus remai...
Eligibility Criteria
Inclusion
- Diagnosis of cutaneous discoid lupus by clinical and histopathological exam
Exclusion
- Systemic lupus involving the internal organs
- Systemic vasculitis
- History of other clinically significant disease process
- History of HIV, hepatitis B or C
- Concurrent use of immune modulating therapy
- Evidence of incompletely treated tuberculosis
- Pregnant or lactating female
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2010
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT00708916
Start Date
June 1 2008
End Date
August 1 2010
Last Update
March 3 2021
Active Locations (1)
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1
New York University Tisch Hospital
New York, New York, United States, 10016