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

This study has been completed.
Sponsor:
Collaborators:
Celgene Corporation
Medical University of South Carolina
Information provided by (Responsible Party):
Robert P Baughman, University of Cincinnati
ClinicalTrials.gov Identifier:
NCT00794274
First received: November 19, 2008
Last updated: April 10, 2013
Last verified: April 2013
  Purpose

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


Condition Intervention Phase
Sarcoidosis
Cutaneous Sarcoidosis
Drug: CC-100004
Phase 2
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Efficacy and Safety of CC-10004 in Chronic Cutaneous Sarcoidosis

Resource links provided by NLM:


Further study details as provided by University of Cincinnati:

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 ]

Enrollment: 15
Study Start Date: November 2008
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Open label drug

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

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.
Other Name: Aprelimast

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. 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

Locations
United States, Ohio
University of Cincinnati
Cincinnati, Ohio, United States, 45220
Sponsors and Collaborators
University of Cincinnati
Celgene Corporation
Medical University of South Carolina
Investigators
Principal Investigator: Robert P Baughman University of Cincinnati
  More Information

No publications provided by University of Cincinnati

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Robert P Baughman, Professor of Medicine, University of Cincinnati
ClinicalTrials.gov Identifier: NCT00794274     History of Changes
Other Study ID Numbers: AP0005
Study First Received: November 19, 2008
Last Updated: April 10, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Cincinnati:
Sarcodiosis
tumor necrosis factor

Additional relevant MeSH terms:
Sarcoidosis
Lymphoproliferative Disorders
Lymphatic Diseases
Apremilast
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on August 20, 2014