Primary Outcome Measures:
- Improvement in skin lesions as assessed by a Sarcoidosis Skin Activity and Severity Index (SASI) . [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: No ]
- Change in the quality of life using the Sarcoidosis Health Questionnaire and Short Form-36 (SF-36). [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Change in genomic and proteomic expression of cytokines in paired skin biopsies (non-facial lesions). [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Improvement in pulmonary status, specifically the six-minute walk test, dyspnea score, and forced vital capacity (FVC). [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Intervention Details:
Drug: CC-100004
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.
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.