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

This study has been completed.
Sponsor:
Collaborator:
Celgene Corporation
Information provided by (Responsible Party):
Elizabeth Camacho, New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT00708916
First received: July 1, 2008
Last updated: December 10, 2012
Last verified: December 2012

July 1, 2008
December 10, 2012
June 2008
August 2010   (final data collection date for primary outcome measure)
Cutaneous LE Diseases Area and Severity Index (CLASI) [ Time Frame: Weeks 4, 8, 12 and 16 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00708916 on ClinicalTrials.gov Archive Site
  • Dermatology Quality of Life Index (DQLI) [ Time Frame: Week 4, 8, 12, 16 ] [ Designated as safety issue: No ]
  • Common Terminology Criteria for Adverse Events v3.0 (CTCAE) [ Time Frame: Weeks 1, 2, 4, 6, 8, 10, 12, 16 ] [ Designated as safety issue: Yes ]
  • Dermal and circulating blood plasmacytoid dendritic cell levels [ Time Frame: Weeks 0, 4 (dermal and circulating); week 12 (circulating only) ] [ Designated as safety issue: No ]
  • Dermal and circulating blood T regulatory cell levels [ Time Frame: Weeks 0, 4 (dermal and blood); Week 12 (blood only) ] [ Designated as safety issue: No ]
  • Plasma cytokine levels [ Time Frame: Weeks 0, 4, 12 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Safety Study of Clinical and Immune Effects of Phosphodiesterase 4 (PDE-4) Inhibitor in Cutaneous Lupus Patients
Clinical and Immune-modulating Effects of CC-10004 in Discoid Lupus Erythematosus

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.

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.

Interventional
Phase 1
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Discoid Lupus Erythematosus
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
Active Comparator: Apremilast
CC-10004 20 mg twice daily by mouth for 12 weeks, followed by a 4 week washout period and final assessment
Intervention: Drug: CC-10004
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
August 2010
August 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00708916
AP016
Yes
Elizabeth Camacho, New York University School of Medicine
New York University School of Medicine
Celgene Corporation
Principal Investigator: Andrew G Franks, Jr., MD New York University School of Medicine
New York University School of Medicine
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP