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

Phase 2/Phase 3
18 Years
80 Years
Not Enrolling
Sarcoidosis, Cutaneous Sarcoidosis

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Trial Information

The Efficacy and Safety of CC-10004 in 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.

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)

- Neutrophils ≥ 1500 (≥ 1.5 X 109/L)

- Platelets ≥ 100,000 (≥ 100 X 109/L)

- Serum creatinine ≤ 1.5 mg/dL (≤ 132.6 μmol/L)

- Total bilirubin < 2.0 mg/dL

- Aspartate transaminase (AST [serum glutamic oxaloacetic transaminase, SGOT]) and
alanine transaminase (ALT [serum glutamate pyruvic transaminase, SGPT]) < 1.5x
upper limit of normal (ULN)

- Females of childbearing potential (FCBP)‡ must have a negative urine pregnancy test
at screening (Visit 1). In addition, sexually active FCBP must agree to use TWO of
the following adequate forms of contraception while on study medication: oral,
injectable, or implantable hormonal contraceptives; tubal ligation; intrauterine
device; barrier contraceptive or vasectomized partner. A FCBP must agree to have
pregnancy tests every 28 days while on study medication.

- Males (including those who have had a vasectomy) must agree to use barrier
contraception (latex condoms) when engaging in sexual activity with FCBP while on
study medication and for 84 days after taking the last dose of study medication.

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

- 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.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Improvement in skin lesions as assessed by a Sarcoidosis Skin Activity and Severity Index (SASI) .

Outcome Time Frame:

6 months

Safety Issue:


Principal Investigator

Robert P Baughman

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Cincinnati


United States: Food and Drug Administration

Study ID:




Start Date:

November 2008

Completion Date:

December 2011

Related Keywords:

  • Sarcoidosis
  • Cutaneous Sarcoidosis
  • Sarcodiosis
  • tumor necrosis factor
  • Sarcoidosis



University of Cincinnati Cincinnati, Ohio  45267-0502