The Efficacy and Safety of CC-10004 in Chronic Cutaneous Sarcoidosis
This study has been completed.
Medical University of South Carolina
Information provided by (Responsible Party):
Robert P Baughman, University of Cincinnati
First received: November 19, 2008
Last updated: April 10, 2013
Last verified: April 2013
To determine whether CC-10004, a phosphodiesterase inhibitor, is useful in treating chronic cutaneous sarcoidosis.
||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||The Efficacy and Safety of CC-10004 in Chronic Cutaneous Sarcoidosis
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 ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||December 2011 (Final data collection date for primary outcome measure)
Experimental: Open label drug
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
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.
Other Name: Aprelimast
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.
|Ages Eligible for Study:
||18 Years to 80 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- History of any clinically significant cardiac, endocrinologic, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, immunologic, or other major diseases (not including pulmonary sarcoidosis)
- Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study
- Pregnant or lactating female
- History of active Mycobacterium tuberculosis infection (any subspecies) within 3 years prior to the screening visit. Infections that occurred > 3 years prior to entry must have been effectively treated.
- History of incompletely treated latent Mycobacterium tuberculosis infection (as indicated by a positive Purified Protein Derivative [PPD] skin test or in vitro test [T-SPOT®.TB, QuantiFERON Gold®].
- Clinically significant abnormality on the chest x-ray (CXR) at screening not due to sarcoidosis
- Use of any investigational medication within 28 days.
- Any clinically significant abnormality on 12-lead ECG at screening
- Positive human immunodeficiency virus (HIV), hepatitis B, or hepatitis C laboratory test result indicating active infection at screening
- History of malignancy within previous 5 years (except for treated basal-cell skin carcinoma(s) and/or fewer than 3 treated squamous-cell skin carcinomas)
- Use of infliximab, etanercept, adalimumab, pentoxifylline, or thalidomide in the prior three months.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00794274
|University of Cincinnati
|Cincinnati, Ohio, United States, 45220 |
University of Cincinnati
Medical University of South Carolina
||Robert P Baughman
||University of Cincinnati
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
||Robert P Baughman, Professor of Medicine, University of Cincinnati
History of Changes
|Other Study ID Numbers:
|Study First Received:
||November 19, 2008
||April 10, 2013
||United States: Food and Drug Administration
Keywords provided by University of Cincinnati:
tumor necrosis factor
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on May 30, 2016
Anti-Inflammatory Agents, Non-Steroidal
Peripheral Nervous System Agents
Physiological Effects of Drugs
Sensory System Agents