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A Study to Evaluate Raptiva in Adults With Moderate to Severe Plaque Psoriasis Who Are Candidates for Systemic Therapy

Primary Purpose

Psoriasis

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Raptiva (efalizumab)
Sponsored by
Genentech, Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psoriasis focused on measuring Moderate Plaque Psoriasis, Severe Plaque Psoriasis, Topical

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Signed informed consent Plaque psoriasis covering >=10% of total BSA Diagnosis of plaque psoriasis for at least 6 months Minimal PASI score of 12.0 at screening In the opinion of the investigator, candidate for systemic therapy for psoriasis who has not been previously treated (naive to systemic treatment) or prior treatment with systemic therapy for psoriasis (e.g., PUVA, cyclosporine, corticosteroids, methotrexate, oral retinoids, MMF, thioguanine, hydroxyurea, sirolimus, azathioprine, 6-MP, etanercept) Body weight of <=140 kg 18 to 75 years old For women of childbearing potential, willingness to use an acceptable method of contraception to prevent pregnancy for the duration of the study Willingness to hold sun exposure reasonably constant and to avoid use of tanning booths or other UV light sources during the study Willingness to enter Study ACD2601g Exclusion Criteria: Guttate, erythrodermic, or pustular psoriasis as sole or predominant form of psoriasis History of severe allergic or anaphylactic reactions to humanized monoclonal antibodies or fusion proteins that contain an Ig Fc region Clinically significant psoriasis flare during screening or on the day of randomization History of or ongoing uncontrolled bacterial, viral, fungal, or atypical mycobacterial infection History of opportunistic infections (e.g., systemic fungal infections, parasites) Seropositivity for human immunodeficiency virus (HIV) Pregnancy or lactation WBC count <4000/uL or >14,000/uL Seropositivity for hepatitis B or C virus Hepatic enzymes >=3x the upper limits of normal (ULN) History of active tuberculosis (TB) or currently undergoing treatment for TB Presence of malignancy within the past 5 years, including lymphoproliferative disorders Previous treatment with efalizumab (anti-CD11a) Diagnosis of hepatic cirrhosis, regardless of cause or severity Serum creatinine >=2x the ULN Hospital admission for cardiac disease, stroke, or pulmonary disease within the last year History of substance abuse within the last 5 years Any medical condition that, in the judgment of the investigator, would jeopardize the subject's safety following exposure to study drug

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    April 27, 2005
    Last Updated
    June 19, 2013
    Sponsor
    Genentech, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00109317
    Brief Title
    A Study to Evaluate Raptiva in Adults With Moderate to Severe Plaque Psoriasis Who Are Candidates for Systemic Therapy
    Official Title
    A Phase IIIb, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Multicenter Study to Evaluate the Safety of 1.0 mg/kg Subcutaneously Administered Efalizumab in Adults With Moderate to Severe Plaque Psoriasis Who Are Candidates for Systemic Therapy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2013
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2002 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    February 2003 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Genentech, Inc.

    4. Oversight

    5. Study Description

    Brief Summary
    This is a Phase IIIb, randomized, double-blind, parallel-group, placebo-controlled, multicenter study designed to evaluate the safety and tolerability of efalizumab administered subcutaneously at weekly doses of 1.0 mg/kg in subjects with moderate to severe plaque psoriasis who are candidates for systemic therapy.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Psoriasis
    Keywords
    Moderate Plaque Psoriasis, Severe Plaque Psoriasis, Topical

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    Double
    Allocation
    Randomized
    Enrollment
    686 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Raptiva (efalizumab)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Signed informed consent Plaque psoriasis covering >=10% of total BSA Diagnosis of plaque psoriasis for at least 6 months Minimal PASI score of 12.0 at screening In the opinion of the investigator, candidate for systemic therapy for psoriasis who has not been previously treated (naive to systemic treatment) or prior treatment with systemic therapy for psoriasis (e.g., PUVA, cyclosporine, corticosteroids, methotrexate, oral retinoids, MMF, thioguanine, hydroxyurea, sirolimus, azathioprine, 6-MP, etanercept) Body weight of <=140 kg 18 to 75 years old For women of childbearing potential, willingness to use an acceptable method of contraception to prevent pregnancy for the duration of the study Willingness to hold sun exposure reasonably constant and to avoid use of tanning booths or other UV light sources during the study Willingness to enter Study ACD2601g Exclusion Criteria: Guttate, erythrodermic, or pustular psoriasis as sole or predominant form of psoriasis History of severe allergic or anaphylactic reactions to humanized monoclonal antibodies or fusion proteins that contain an Ig Fc region Clinically significant psoriasis flare during screening or on the day of randomization History of or ongoing uncontrolled bacterial, viral, fungal, or atypical mycobacterial infection History of opportunistic infections (e.g., systemic fungal infections, parasites) Seropositivity for human immunodeficiency virus (HIV) Pregnancy or lactation WBC count <4000/uL or >14,000/uL Seropositivity for hepatitis B or C virus Hepatic enzymes >=3x the upper limits of normal (ULN) History of active tuberculosis (TB) or currently undergoing treatment for TB Presence of malignancy within the past 5 years, including lymphoproliferative disorders Previous treatment with efalizumab (anti-CD11a) Diagnosis of hepatic cirrhosis, regardless of cause or severity Serum creatinine >=2x the ULN Hospital admission for cardiac disease, stroke, or pulmonary disease within the last year History of substance abuse within the last 5 years Any medical condition that, in the judgment of the investigator, would jeopardize the subject's safety following exposure to study drug

    12. IPD Sharing Statement

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    A Study to Evaluate Raptiva in Adults With Moderate to Severe Plaque Psoriasis Who Are Candidates for Systemic Therapy

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