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Efalizumab for Moderate to Severe Atopic Dermatitis

Primary Purpose

Dermatitis, Atopic

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Raptiva
Sponsored by
Oregon Health and Science University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dermatitis, Atopic focused on measuring Atopic dermatitis, Raptiva

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Ability to provide written informed consent and comply with study assessments for the full duration of the study Age >= 18 years If a female of child bearing potential, a negative pregnancy test and commitment to birth control for the duration of the study are necessary. Diagnosis of atopic dermatitis using the Hanifin-Rajka criteria Disease severity of Moderate or Severe on the Rajka-Langeland Severity Score Candidate for, or previously on systemic therapy, including cyclosporine, methotrexate, ultraviolet light or other immunosuppressant. Specifically, patients 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. Patients must meet the following washout requirements: Pre-Study and Concomitant Washout Period Restriction (Baseline Therapy Restrictions Prior to Study Thru End of Study) Investigational Drugs 4 Weeks Disallowed Light Treatments 4 Weeks Disallowed Systemic corticosteroid used 4 Weeks Disallowed for atopic dermatitis flare Topical tacrolimus or 2 Weeks Disallowed pimecrolimus Topical corticosteroids Must be on stable Allowed at stable doses dose for 2 weeks (Triamcinolone ointment 0.1% only) Any systemic 4 Weeks Disallowed immunosuppressive medication Topical and systemic antibiotics Cannot be on Allowed if infection antibiotics at the develops start of study Exclusion Criteria: Patient's with known hypersensitivity to Raptiva (efalizumab) or any of its components Pregnant or lactating women Patients receiving immunosuppressive agents Prior enrollment in the study Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated. Participation in another simultaneous medical investigation or trial Subjects known to be immunocompromised(lymphoma, HIV+, Wiskott-Aldrich syndrome) Systemic corticosteroid-dependent asthma Active infection of any type at the time of enrollment

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Raptiva Open Label

    Arm Description

    Raptiva administered by weekly subcutaneous injections. First dose of 0.7mg/kg. Subsequent doses will be of 1mg/kg SQ weekly.

    Outcomes

    Primary Outcome Measures

    Evaluate the safety and effectiveness of Raptiva in patients with moderate to severe atopic dermatitis
    The primary efficacy outcome measure will be the change in mean Eczema Area and Severity Index (EASI) score from baseline

    Secondary Outcome Measures

    Improvement in EASI score
    Total percent of patients reaching 50% improvement in EASI score
    Improvement in IGA score
    Numbers of patient reaching clear, almost clear or mild disease on the Investigator Global Assessment (IGA) Score
    Subject's assessment of overall response
    Subject's assessment of overall response
    Change in serum IgE level
    Change in serum IgE Level
    Pruritis (0-10 VAS Scale) change
    Pruritis (0-10 VAS Scale) change
    Time to first response
    Time to first response as defined by a decrease of 25% in EASI score

    Full Information

    First Posted
    September 22, 2005
    Last Updated
    December 31, 2019
    Sponsor
    Oregon Health and Science University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00226057
    Brief Title
    Efalizumab for Moderate to Severe Atopic Dermatitis
    Official Title
    Efalizumab for Moderate to Severe Atopic Dermatitis - A Phase I Pilot Study in Adults
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2005 (Actual)
    Primary Completion Date
    November 2005 (Actual)
    Study Completion Date
    May 2006 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    5. Study Description

    Brief Summary
    The purpose of this study is to determine if Raptiva will have beneficial effects in the treatment of patients with moderate to severe atopic dermatitis.
    Detailed Description
    Atopic dermatitis is a common, highly pruritic, inflammatory skin disease that affects up to 17% of school-aged children. Most cases of childhood atopic dermatitis improve or resolve by adulthood. However, the majority of patients retain some features of atopic dermatitis and some continue to have severe disease that continues to adulthood. Moderate to severe atopic dermatitis cannot be adeuately controlled with topical agents. Consequently many patients are treated with systemic corticosteroids, cyclosporine, azathioprine, methotrexate, and other immunosuppressants that carry the risk of severe atopic dermatitis is greatly needed. The chronic use of current immunosuppressive agents is limited by cumulative end-organ toxicities. We propose inhibition of T cell trafficking to the skin with Raptiva will have beneficial effects in the treatment of patients with moderate to severe atopic dermatitis.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    10 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Raptiva Open Label
    Arm Type
    Experimental
    Arm Description
    Raptiva administered by weekly subcutaneous injections. First dose of 0.7mg/kg. Subsequent doses will be of 1mg/kg SQ weekly.
    Intervention Type
    Drug
    Intervention Name(s)
    Raptiva
    Other Intervention Name(s)
    Efalizumab
    Intervention Description
    Open Label
    Primary Outcome Measure Information:
    Title
    Evaluate the safety and effectiveness of Raptiva in patients with moderate to severe atopic dermatitis
    Description
    The primary efficacy outcome measure will be the change in mean Eczema Area and Severity Index (EASI) score from baseline
    Time Frame
    EASI Score collected at 12 weeks following baseline
    Secondary Outcome Measure Information:
    Title
    Improvement in EASI score
    Description
    Total percent of patients reaching 50% improvement in EASI score
    Time Frame
    Assessed 12 weeks after baseline
    Title
    Improvement in IGA score
    Description
    Numbers of patient reaching clear, almost clear or mild disease on the Investigator Global Assessment (IGA) Score
    Time Frame
    Assessed 12 weeks after baseline
    Title
    Subject's assessment of overall response
    Description
    Subject's assessment of overall response
    Time Frame
    End of study
    Title
    Change in serum IgE level
    Description
    Change in serum IgE Level
    Time Frame
    Serum IgE collected at 12 weeks following baseline
    Title
    Pruritis (0-10 VAS Scale) change
    Description
    Pruritis (0-10 VAS Scale) change
    Time Frame
    VAS scale collected at 12 weeks following baseline
    Title
    Time to first response
    Description
    Time to first response as defined by a decrease of 25% in EASI score
    Time Frame
    Assessed on Days 28,56, and 84

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Ability to provide written informed consent and comply with study assessments for the full duration of the study Age >= 18 years If a female of child bearing potential, a negative pregnancy test and commitment to birth control for the duration of the study are necessary. Diagnosis of atopic dermatitis using the Hanifin-Rajka criteria Disease severity of Moderate or Severe on the Rajka-Langeland Severity Score Candidate for, or previously on systemic therapy, including cyclosporine, methotrexate, ultraviolet light or other immunosuppressant. Specifically, patients 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. Patients must meet the following washout requirements: Pre-Study and Concomitant Washout Period Restriction (Baseline Therapy Restrictions Prior to Study Thru End of Study) Investigational Drugs 4 Weeks Disallowed Light Treatments 4 Weeks Disallowed Systemic corticosteroid used 4 Weeks Disallowed for atopic dermatitis flare Topical tacrolimus or 2 Weeks Disallowed pimecrolimus Topical corticosteroids Must be on stable Allowed at stable doses dose for 2 weeks (Triamcinolone ointment 0.1% only) Any systemic 4 Weeks Disallowed immunosuppressive medication Topical and systemic antibiotics Cannot be on Allowed if infection antibiotics at the develops start of study Exclusion Criteria: Patient's with known hypersensitivity to Raptiva (efalizumab) or any of its components Pregnant or lactating women Patients receiving immunosuppressive agents Prior enrollment in the study Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated. Participation in another simultaneous medical investigation or trial Subjects known to be immunocompromised(lymphoma, HIV+, Wiskott-Aldrich syndrome) 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
    Organizational Affiliation
    Oregon Health and Science University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    11004621
    Citation
    Laughter D, Istvan JA, Tofte SJ, Hanifin JM. The prevalence of atopic dermatitis in Oregon schoolchildren. J Am Acad Dermatol. 2000 Oct;43(4):649-55. doi: 10.1067/mjd.2000.107773.
    Results Reference
    background
    PubMed Identifier
    9892950
    Citation
    Williams HC, Strachan DP. The natural history of childhood eczema: observations from the British 1958 birth cohort study. Br J Dermatol. 1998 Nov;139(5):834-9. doi: 10.1046/j.1365-2133.1998.02509.x.
    Results Reference
    background
    PubMed Identifier
    8943405
    Citation
    Werther WA, Gonzalez TN, O'Connor SJ, McCabe S, Chan B, Hotaling T, Champe M, Fox JA, Jardieu PM, Berman PW, Presta LG. Humanization of an anti-lymphocyte function-associated antigen (LFA)-1 monoclonal antibody and reengineering of the humanized antibody for binding to rhesus LFA-1. J Immunol. 1996 Dec 1;157(11):4986-95.
    Results Reference
    background
    PubMed Identifier
    6337197
    Citation
    Leung DY, Bhan AK, Schneeberger EE, Geha RS. Characterization of the mononuclear cell infiltrate in atopic dermatitis using monoclonal antibodies. J Allergy Clin Immunol. 1983 Jan;71(1 Pt 1):47-56. doi: 10.1016/0091-6749(83)90546-8.
    Results Reference
    background
    PubMed Identifier
    10926735
    Citation
    Reitamo S, Wollenberg A, Schopf E, Perrot JL, Marks R, Ruzicka T, Christophers E, Kapp A, Lahfa M, Rubins A, Jablonska S, Rustin M. Safety and efficacy of 1 year of tacrolimus ointment monotherapy in adults with atopic dermatitis. The European Tacrolimus Ointment Study Group. Arch Dermatol. 2000 Aug;136(8):999-1006. doi: 10.1001/archderm.136.8.999.
    Results Reference
    background
    PubMed Identifier
    8432915
    Citation
    Hanifin JM, Schneider LC, Leung DY, Ellis CN, Jaffe HS, Izu AE, Bucalo LR, Hirabayashi SE, Tofte SJ, Cantu-Gonzales G, et al. Recombinant interferon gamma therapy for atopic dermatitis. J Am Acad Dermatol. 1993 Feb;28(2 Pt 1):189-97. doi: 10.1016/0190-9622(93)70026-p.
    Results Reference
    background

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    Efalizumab for Moderate to Severe Atopic Dermatitis

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