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The Efficacy and Safety of CC-10004 in Chronic Cutaneous Sarcoidosis | Clinical Trials | Clareo Health

COMPLETEDPHASE2/PHASE3

The Efficacy and Safety of CC-10004 in Chronic Cutaneous Sarcoidosis

NCT00794274•University of Cincinnati

View on ClinicalTrials.gov

Summary

To determine whether CC-10004, a phosphodiesterase inhibitor, is useful in treating chronic cutaneous sarcoidosis.

Detailed Description

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.

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Must understand and voluntarily sign an informed consent form
•Must be male or female and aged ≥ 18 years at time of consent
•Must be able to adhere to the study visit schedule and other protocol requirements
•Patients with sarcoidosis as defined by the ATS/ERS/WASOG statement on sarcoidosis as defined by the clinical presentation consistent with sarcoidosis, biopsy finding granulomas, and no alternative for the cause of the granulomas, such as tuberculosis
•Patients must have chronic cutaneous skin lesions while taking chronic therapy (corticosteroids, methotrexate (max 10mg/week), azathioprine, hydroxychloroquine, cyclophosphamide, minocycline, doxycycline and chloroquine), in which the dose has not been altered in the three months prior to starting the study.
•Must have two visits within the previous 1-6 months (at least one month apart) with stable skin lesions, such as a SASI score was within one point for each of the features of the lesion.
•Must meet the following laboratory criteria:
•* Hemoglobin \> 9 g/dL
•* Hematocrit ≥ 27%
•* White blood cell (WBC) count ≥ 3000 (≥ 3.0 X 109/L) and \< 20,000 (\< 20 X 109/L)
+7 more criteria

Exclusion Criteria

•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)
+1 more criteria

Locations (1)

University of Cincinnati

Cincinnati, Ohio, United States

Key Dates

Start Date

November 1, 2008

Primary Completion Date

December 1, 2011

Completion Date

December 1, 2011

Last Updated

April 12, 2013

Enrollment

ACTUAL participants

Conditions

SarcoidosisCutaneous Sarcoidosis

Interventions

CC-100004

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 12, 2013Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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The Efficacy and Safety of CC-10004 in Chronic Cutaneous Sarcoidosis

Inclusion Criteria

Exclusion Criteria

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