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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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
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
No publications provided by University of Cincinnati
Additional 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 August 19, 2014
Anti-Inflammatory Agents, Non-Steroidal
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents