To determine whether CC-10004, a phosphodiesterase inhibitor, is useful in treating chronic cutaneous sarcoidosis.
This will be an open label, phase II trial of CC-10004 for chronic cutaneous sarcoidosis. It will include two centers (University of Cincinnati and Medical University of South Carolina). The study will evaluate patients with chronic disease who are on a stable treatment regimen and have no significant change in their Sarcoidosis Skin Activity and Severity Index score (SASI) at two visits at least one month apart.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
After the screening period, subjects will receive CC-10004 20mg by mouth BID for 84 days. The 84-day duration of treatment is expected to provide adequate time to assess the short-term efficacy and safety of CC-10004 in a population of subjects with chronic cutaneous sarcoidosis.
University of Cincinnati
Cincinnati, Ohio, United States
Improvement in skin lesions as assessed by a Sarcoidosis Skin Activity and Severity Index (SASI) .
Time frame: 6 months
To determine the safety (type, frequency, severity, and relationship of adverse events to study treatment) of CC-10004 in patients with chronic cutaneous sarcoidosis.
Time frame: 6 months
Improvement of global score of sarcoidosis using a visual analogue scale (VAS) by both the patient and a separate VAS by the physician.
Time frame: 6 months
Change in the quality of life using the Sarcoidosis Health Questionnaire and Short Form-36 (SF-36).
Time frame: 6 months
Change in genomic and proteomic expression of cytokines in paired skin biopsies (non-facial lesions).
Time frame: 6 months
Improvement in pulmonary status, specifically the six-minute walk test, dyspnea score, and forced vital capacity (FVC).
Time frame: 6 months
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