search
Back to results

Apremilast for Atopic Dermatitis - A Pilot Study in Adults

Primary Purpose

Atopic Dermatitis

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Apremilast
Sponsored by
Oregon Health and Science University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atopic Dermatitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Disease severity of Moderate, Severe, or Very Severe by Investigator Global Assessment.
  • Disease severity must be greater than or equal to 6 on the Rajka-Langeland Severity Scoring system corresponding to moderate-severe disease.
  • Baseline EASI score must be greater than or equal to 11. A previous validation study for the EASI scoring system revealed patients with moderate to very severe disease had mean EASI scores ranging from 11-30.
  • Candidate for, or previously on systemic therapy, including cyclosporine, methotrexate, or other immunosuppressant and treatment with ultraviolet light. Specifically, subjects are considered candidates for systemic therapy when their disease is not adequately controlled using topical therapies or side-effects prevent the further safe use of topical therapies.
  • Subjects must meet the washout requirements

Exclusion Criteria:

  • History of active mycobacterial infection with any species (including Mycobacterium tuberculosis) within 3 years prior to screening visit. Subjects with Mycobacterium tuberculosis infection more than 3 years prior to screening visit are allowed if successful treatment was completed at least 3 years prior to randomization and is documented and available for verification.
  • At least 3 major bacterial infections resulting in hospitalization and/or requiring intravenous antibiotic treatment within the past 2 years.
  • Clinically significant abnormality on the chest X-ray (CXR) at screening. Chest X-rays performed within 3 months prior to start of study drug are acceptable.
  • Use of any investigational medication within 4 weeks prior to start of study drug or 5 pharmacokinetic/pharmacodynamic half-lives (whichever is longer).
  • Any clinically significant abnormality on 12-lead ECG (electrocardiogram) at screening.
  • History of congenital or acquired immunodeficiency (e.g., Common Variable Immunodeficiency [CVID]).
  • Hepatitis B surface antigen positive or Hepatitis B core antibody positive at screening.
  • History of Human Immunodeficiency Virus (HIV) infection.
  • Antibodies to Hepatitis C at screening.
  • History of squamous cell carcinoma of the skin and thin melanoma.
  • Systemic corticosteroid-dependent asthma.
  • Active infection of any type at the time of enrollment.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    20 mg BID

    30 mg BID

    Arm Description

    Patients dosed with 20 mg orally of Apremilast BID for 3 months.

    Patients dosed with 30 mg orally of Apremilast BID for 6 months.

    Outcomes

    Primary Outcome Measures

    Change in EASI Scores
    The eczema area and severity index (EASI) is a composite score measuring physical signs of atopic dermatitis. The scale ranges from 0-72. The components measuring severity are four signs/symptoms of atopic dermatitis: erythema, population, excoriation and lichenification on a scale of 0-3 for each body of the four body regions (head/neck, trunk, arms, legs). The component measuring area is a body surface area measurement of each region. The area and severity of each body region is weighted based on size of region which are added together for the complete score. The score for each patient's with scores between 0 and 7 are considered mild ,between 7 and 21 are considered moderate, and greater than 21 are considered severe. In this study the change in EASI score between baseline and month three (end of study) in the 20 mg arm and month six in the 30 mg arm, baseline EASI score was subtracted from month 3 or month 6 score in the 30mg arm,and calculated as a final outcome data point.

    Secondary Outcome Measures

    Number of Participants in Each IGA Category
    The investigator global assessment scale is a gestalt global assessment made by an investigator describing the overall disease severity of the patient. It is a categorical scale that includes 0-clear, 1-almost clear, 2-mild,3- moderate, 4-severe, and 5-very severe. The reduction in IGA score from baseline to month three (end of study) in the 20mg arm and month six (end of study) in the 30mg arm was evaluated for efficacy.
    Change in Pruritus (Visual Analog Scale) Score
    The pruritus visual analog scale (VAS) is a 10 cm (100 mm) visual analog scale that measures up patient's itch severity with 10 (100 mm) representing the worst imaginable and 0 representing no itch. This is a validated scale with a change of three from baseline to month three in the 20mg arm (end of study) and month six in the 30mg arm (end of study) being clinically relevant.
    Change In DLQI Scores
    The dermatology life quality index (DLQI) is a validated quality-of-life scale that measures the impact of skin disease. It is a 10 question instrument. Scores of 0 over 0-1 means there is no effect on the patient's life. Scores between 2 and 5 represent a small effect on patient's life. Scores between 6 and 10 correspond to a moderate effect on patient's life. Scores between 11 and 20 correspond to a very large effect on the patient's life. And scores between 21 and 30 correspond to an extremely large effect on patient's life. The range of the scale between 0 and 30 for the added total of the patient's responses. Each question can be answered on a scale of 0-"not at all", 1-"a little", 2-" a lot", 3- "very much" with some questions having the option of "not relevant". The difference in DLQI score from baseline to month three (end of study) in the 20mg arm and month six (end of study) in the 30mg arm was evaluated for efficacy.

    Full Information

    First Posted
    July 12, 2011
    Last Updated
    December 31, 2019
    Sponsor
    Oregon Health and Science University
    Collaborators
    Celgene Corporation
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT01393158
    Brief Title
    Apremilast for Atopic Dermatitis - A Pilot Study in Adults
    Official Title
    A Pilot Study of an Oral Phosphodiesterase Inhibitor (Apremilast) for Atopic Dermatitis in Adults
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2009 (undefined)
    Primary Completion Date
    July 2011 (Actual)
    Study Completion Date
    July 2011 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Oregon Health and Science University
    Collaborators
    Celgene Corporation

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to obtain preliminary data regarding the safety and tolerability of apremilast in AD to support the design of larger controlled studies.
    Detailed Description
    To investigate the preliminary safety and efficacy of apremilast, an oral phosphodiesterase 4 inhibitor, for atopic dermatitis.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Atopic Dermatitis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Sequential Assignment
    Model Description
    20mg cohort enrolled and completed before the 30mg cohort enrolled.
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    16 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    20 mg BID
    Arm Type
    Experimental
    Arm Description
    Patients dosed with 20 mg orally of Apremilast BID for 3 months.
    Arm Title
    30 mg BID
    Arm Type
    Experimental
    Arm Description
    Patients dosed with 30 mg orally of Apremilast BID for 6 months.
    Intervention Type
    Drug
    Intervention Name(s)
    Apremilast
    Other Intervention Name(s)
    Otezla
    Intervention Description
    20mg of Apremilast taken orally BID for 3 months or 30 mg of Apremilast taken orally BID for 6 months.
    Primary Outcome Measure Information:
    Title
    Change in EASI Scores
    Description
    The eczema area and severity index (EASI) is a composite score measuring physical signs of atopic dermatitis. The scale ranges from 0-72. The components measuring severity are four signs/symptoms of atopic dermatitis: erythema, population, excoriation and lichenification on a scale of 0-3 for each body of the four body regions (head/neck, trunk, arms, legs). The component measuring area is a body surface area measurement of each region. The area and severity of each body region is weighted based on size of region which are added together for the complete score. The score for each patient's with scores between 0 and 7 are considered mild ,between 7 and 21 are considered moderate, and greater than 21 are considered severe. In this study the change in EASI score between baseline and month three (end of study) in the 20 mg arm and month six in the 30 mg arm, baseline EASI score was subtracted from month 3 or month 6 score in the 30mg arm,and calculated as a final outcome data point.
    Time Frame
    Mean change in EASI score measured at Baseline and Month 3, (if on 20mg arm) or Baseline and Month 6 (if on 30mg arm)
    Secondary Outcome Measure Information:
    Title
    Number of Participants in Each IGA Category
    Description
    The investigator global assessment scale is a gestalt global assessment made by an investigator describing the overall disease severity of the patient. It is a categorical scale that includes 0-clear, 1-almost clear, 2-mild,3- moderate, 4-severe, and 5-very severe. The reduction in IGA score from baseline to month three (end of study) in the 20mg arm and month six (end of study) in the 30mg arm was evaluated for efficacy.
    Time Frame
    Mean change in IGA score measured at Baseline and Month 3, (if on 20mg arm) or Baseline and Month 6 (if on 30mg arm)
    Title
    Change in Pruritus (Visual Analog Scale) Score
    Description
    The pruritus visual analog scale (VAS) is a 10 cm (100 mm) visual analog scale that measures up patient's itch severity with 10 (100 mm) representing the worst imaginable and 0 representing no itch. This is a validated scale with a change of three from baseline to month three in the 20mg arm (end of study) and month six in the 30mg arm (end of study) being clinically relevant.
    Time Frame
    Mean change in Pruritus (Visual Analog Scale) score measured at Baseline and Month 3, (if on 20mg arm) or Baseline and Month 6 (if on 30mg arm)
    Title
    Change In DLQI Scores
    Description
    The dermatology life quality index (DLQI) is a validated quality-of-life scale that measures the impact of skin disease. It is a 10 question instrument. Scores of 0 over 0-1 means there is no effect on the patient's life. Scores between 2 and 5 represent a small effect on patient's life. Scores between 6 and 10 correspond to a moderate effect on patient's life. Scores between 11 and 20 correspond to a very large effect on the patient's life. And scores between 21 and 30 correspond to an extremely large effect on patient's life. The range of the scale between 0 and 30 for the added total of the patient's responses. Each question can be answered on a scale of 0-"not at all", 1-"a little", 2-" a lot", 3- "very much" with some questions having the option of "not relevant". The difference in DLQI score from baseline to month three (end of study) in the 20mg arm and month six (end of study) in the 30mg arm was evaluated for efficacy.
    Time Frame
    Mean change in DLQI scores measured at Baseline and Month 3, (if on 20mg arm) or Baseline and Month 6 (if on 30mg arm)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Disease severity of Moderate, Severe, or Very Severe by Investigator Global Assessment. Disease severity must be greater than or equal to 6 on the Rajka-Langeland Severity Scoring system corresponding to moderate-severe disease. Baseline EASI score must be greater than or equal to 11. A previous validation study for the EASI scoring system revealed patients with moderate to very severe disease had mean EASI scores ranging from 11-30. Candidate for, or previously on systemic therapy, including cyclosporine, methotrexate, or other immunosuppressant and treatment with ultraviolet light. Specifically, subjects are considered candidates for systemic therapy when their disease is not adequately controlled using topical therapies or side-effects prevent the further safe use of topical therapies. Subjects must meet the washout requirements Exclusion Criteria: History of active mycobacterial infection with any species (including Mycobacterium tuberculosis) within 3 years prior to screening visit. Subjects with Mycobacterium tuberculosis infection more than 3 years prior to screening visit are allowed if successful treatment was completed at least 3 years prior to randomization and is documented and available for verification. At least 3 major bacterial infections resulting in hospitalization and/or requiring intravenous antibiotic treatment within the past 2 years. Clinically significant abnormality on the chest X-ray (CXR) at screening. Chest X-rays performed within 3 months prior to start of study drug are acceptable. Use of any investigational medication within 4 weeks prior to start of study drug or 5 pharmacokinetic/pharmacodynamic half-lives (whichever is longer). Any clinically significant abnormality on 12-lead ECG (electrocardiogram) at screening. History of congenital or acquired immunodeficiency (e.g., Common Variable Immunodeficiency [CVID]). Hepatitis B surface antigen positive or Hepatitis B core antibody positive at screening. History of Human Immunodeficiency Virus (HIV) infection. Antibodies to Hepatitis C at screening. History of squamous cell carcinoma of the skin and thin melanoma. Systemic corticosteroid-dependent asthma. Active infection of any type at the time of enrollment.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Eric L Simpson, MD, MCR
    Organizational Affiliation
    Oregon Health and Science University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    22508772
    Citation
    Samrao A, Berry TM, Goreshi R, Simpson EL. A pilot study of an oral phosphodiesterase inhibitor (apremilast) for atopic dermatitis in adults. Arch Dermatol. 2012 Aug;148(8):890-7. doi: 10.1001/archdermatol.2012.812.
    Results Reference
    derived

    Learn more about this trial

    Apremilast for Atopic Dermatitis - A Pilot Study in Adults

    We'll reach out to this number within 24 hrs