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Safety Study of Clinical and Immune Effects of Phosphodiesterase 4 (PDE-4) Inhibitor in Cutaneous Lupus Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00708916
Recruitment Status : Completed
First Posted : July 3, 2008
Last Update Posted : December 11, 2012
Celgene Corporation
Information provided by (Responsible Party):
Elizabeth Camacho, NYU Langone Health

Brief Summary:
The purpose of this study is to determine the clinical and immunological effects of the phosphodiesterase type 4 inhibitor, CC-10004, on skin inflammation associated with cutaneous lupus erythematosus.

Condition or disease Intervention/treatment Phase
Discoid Lupus Erythematosus Drug: CC-10004 Phase 1 Phase 2

Detailed Description:
Discoid cutaneous lupus is the most common cutaneous manifestation of lupus erythematosus, a chronic, immune mediated disease of unknown etiology. The immune processes underlying cutaneous lupus remain largely unexplored, but recent evidence suggests a role for dendritic cells (DCs), type 1 interferons (IFN) and Th1-type immune processes. Treatment of cutaneous lupus remains limited primarily to anti-malarials, with thalidomide an effective secondary agent. However, side effects associated with these treatments are potentially problematic with chronic use. Phosphodiesterases (PDE) are critical enzymes that degrade cAMP. In particular, PDE type 4 (PDE4) activity is found in inflammatory and immune cells, including DCs. The immune modulator CC-10004 is a PDE4 inhibitor with demonstrated low toxicity in phase I and II clinical studies with potential efficacy in cutaneous lupus. CC-10004 is a well-tolerated, selective PDE4 inhibitor with demonstrated inhibitory effects on Th1-type cytokines and other inflammatory mediators and is under development for the treatment of inflammatory and immune mediated conditions. Prior studies include pilot trials in psoriasis and exercise-induced asthma, with results suggesting clinical efficacy in the former study. This open label, pilot study of 16 weeks duration will explore the clinical and immune-modulating effects of CC-10004 in 10 cutaneous discoid lupus patients. Patients meeting study criteria will receive the drug for 12 weeks, followed by a 4-week washout period. Study visit time points will include weeks 0, 1, 2, 4, 6, 8, 10, 12 and 16, during which we will measure outcomes for clinical, immunological and safety parameters. To investigate early immunological changes occurring in response to treatment, we will also perform skin punch biopsies of lesional sites at week 0 and week 4 for immunohistochemical and molecular analysis.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical and Immune-modulating Effects of CC-10004 in Discoid Lupus Erythematosus
Study Start Date : June 2008
Actual Primary Completion Date : August 2010
Actual Study Completion Date : August 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus
Drug Information available for: Apremilast

Arm Intervention/treatment
Active Comparator: Apremilast
CC-10004 20 mg twice daily by mouth for 12 weeks, followed by a 4 week washout period and final assessment
Drug: CC-10004
20 mg twice daily by mouth for 12 weeks, followed by a 4 week washout period and final assessment
Other Name: Apremilast

Primary Outcome Measures :
  1. Cutaneous LE Diseases Area and Severity Index (CLASI) [ Time Frame: Weeks 4, 8, 12 and 16 ]

Secondary Outcome Measures :
  1. Dermatology Quality of Life Index (DQLI) [ Time Frame: Week 4, 8, 12, 16 ]
  2. Common Terminology Criteria for Adverse Events v3.0 (CTCAE) [ Time Frame: Weeks 1, 2, 4, 6, 8, 10, 12, 16 ]
  3. Dermal and circulating blood plasmacytoid dendritic cell levels [ Time Frame: Weeks 0, 4 (dermal and circulating); week 12 (circulating only) ]
  4. Dermal and circulating blood T regulatory cell levels [ Time Frame: Weeks 0, 4 (dermal and blood); Week 12 (blood only) ]
  5. Plasma cytokine levels [ Time Frame: Weeks 0, 4, 12 ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Diagnosis of cutaneous discoid lupus by clinical and histopathological exam

Exclusion Criteria:

  • Systemic lupus involving the internal organs
  • Systemic vasculitis
  • History of other clinically significant disease process
  • History of HIV, hepatitis B or C
  • Concurrent use of immune modulating therapy
  • Evidence of incompletely treated tuberculosis
  • Pregnant or lactating female

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00708916

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United States, New York
New York University Tisch Hospital
New York City, New York, United States, 10016
Sponsors and Collaborators
NYU Langone Health
Celgene Corporation
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Principal Investigator: Andrew G Franks, Jr., MD NYU Langone Health
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Responsible Party: Elizabeth Camacho, PRS, NYU Langone Health Identifier: NCT00708916    
Other Study ID Numbers: AP016
First Posted: July 3, 2008    Key Record Dates
Last Update Posted: December 11, 2012
Last Verified: December 2012
Keywords provided by Elizabeth Camacho, NYU Langone Health:
Cutaneous lupus
Discoid lupus
Phosphodiesterase 5 inhibitor
Additional relevant MeSH terms:
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Lupus Erythematosus, Discoid
Connective Tissue Diseases
Lupus Erythematosus, Cutaneous
Skin Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents