Safety Study of Clinical and Immune Effects of Phosphodiesterase 4 (PDE-4) Inhibitor in Cutaneous Lupus Patients

• Status: Completed
• Trial end date: 2010-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: New York University School of Medicine; NYU Langone Health
• Collaborator: Celgene Corporation
• Treatments: Apremilast; Phosphodiesterase 5 Inhibitors

Criteria

Inclusion Criteria:

• Diagnosis of cutaneous discoid lupus by clinical and histopathological exam

Exclusion Criteria:

• 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