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

Sarcoidosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00794274
• Other study ID #: AP0005
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: November 19, 2008
• Last updated: April 10, 2013
• Start date: November 2008
• Est. completion date: December 2011

Study information

• Verified date: April 2013
• Source: University of Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 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.

Study Design

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

Related Conditions & MeSH terms

• Cutaneous Sarcoidosis
• Sarcoidosis

Intervention

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.

Locations

Country	Name	City	State
United States	University of Cincinnati	Cincinnati	Ohio

Sponsors (3)

Lead Sponsor	Collaborator
University of Cincinnati	Celgene Corporation, Medical University of South Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in skin lesions as assessed by a Sarcoidosis Skin Activity and Severity Index (SASI) .		6 months	No
Secondary	To determine the safety (type, frequency, severity, and relationship of adverse events to study treatment) of CC-10004 in patients with chronic cutaneous sarcoidosis.		6 months	Yes
Secondary	Improvement of global score of sarcoidosis using a visual analogue scale (VAS) by both the patient and a separate VAS by the physician.		6 months	No
Secondary	Change in the quality of life using the Sarcoidosis Health Questionnaire and Short Form-36 (SF-36).		6 months	No
Secondary	Change in genomic and proteomic expression of cytokines in paired skin biopsies (non-facial lesions).		6 months	No
Secondary	Improvement in pulmonary status, specifically the six-minute walk test, dyspnea score, and forced vital capacity (FVC).		6 months	No