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Completed

NCT Number: NCT00708916

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

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.

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Key information

Conditions

Discoid Lupus Erythematosus Connective Tissue Diseases Lupus Erythematosus, Cutaneous Lupus Erythematosus, Discoid Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

New York University Tisch Hospital

New York, 10016, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CC-10004

Drug

20 mg twice daily by mouth for 12 weeks, followed by a 4 week washout period and final assessment

Other names: Apremilast

Primary outcomes

  1. Cutaneous LE Diseases Area and Severity Index (CLASI) Score Based on Extent of Symptoms

    Time frame: 16 Weeks

    To evaluate the clinical response of cutaneous lupus patients to CC-10004. From J Invest Dermatol. 2005 Nov; 125(5): 889-894.doi: 10.1111/j.0022-202X.2005.23889.x:

    The CLASI consists of two scores. One summarizes the activity of the disease on a scale from 0 to 30, higher score translates to more severe disease. The second is a measure of the damage done by the disease on a scale form 0 to 30, higher score translates to more severe disease. Activity is scored on the basis of erythema, scale/hyperkeratosis, mucous membrane involvement, acute hair loss and non-scarring alopecia. Damage is scored in terms of dyspigmentation and scarring, including scarring alopecia. Each score is reported separately. Outcome measures are reported for each time point for each subject due to the low numbers of enrollment.

Secondary outcomes

  1. Dermatology Quality of Life Index (DQLI)

    Time frame: 16 Weeks

    • To evaluate the clinical safety of CC-10004 in cutaneous lupus patients
    • To determine the effect of CC-10004 on immune parameters in the skin
    • To determine the effect of CC-10004 on immune parameters in the blood
    • in vivo
    • in vitro
    • To determine the effect of CC-10004 on QOL and psychological outcome measures

  2. Common Terminology Criteria for Adverse Events v3.0 (CTCAE)

    Time frame: Weeks 1, 2, 4, 6, 8, 10, 12, 16

    • To evaluate the clinical safety of CC-10004 in cutaneous lupus patients
    • To determine the effect of CC-10004 on immune parameters in the skin
    • To determine the effect of CC-10004 on immune parameters in the blood
    • in vivo
    • in vitro
    • To determine the effect of CC-10004 on QOL and psychological outcome measures

  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)

    • To evaluate the clinical safety of CC-10004 in cutaneous lupus patients
    • To determine the effect of CC-10004 on immune parameters in the skin
    • To determine the effect of CC-10004 on immune parameters in the blood
    • in vivo
    • in vitro
    • To determine the effect of CC-10004 on QOL and psychological outcome measures

  5. Plasma Cytokine Levels

    Time frame: Weeks 0, 4, 12

    • To evaluate the clinical safety of CC-10004 in cutaneous lupus patients
    • To determine the effect of CC-10004 on immune parameters in the skin
    • To determine the effect of CC-10004 on immune parameters in the blood
    • in vivo
    • in vitro
    • To determine the effect of CC-10004 on QOL and psychological outcome measures

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Collaborators

  • Celgene Corporation

Registry information

Official study title

Clinical and Immune-modulating Effects of CC-10004 in Discoid Lupus Erythematosus

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Jul 3, 2008
Registry last updated
Mar 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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