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A Study to Evaluate the Safety and Efficacy of Efalizumab in Adult Patients With Plaque Psoriasis Involving the Hands and/or Feet

Primary Purpose

Psoriasis

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
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 Plaque Psoriasis, Hands, Feet, Hand

Eligibility Criteria

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

Inclusion Criteria: Provide written informed consent and Health Insurance Portability and Accountability Act of 1996 (HIPAA) documents Be aged 18 years or older Have chronic (6 months or greater) moderate to severe plaque psoriasis involving the hands and/or feet with or without pustules and with or without psoriasis at other sites Have a PGA rating of moderate (3) or severe (4) for hand and/or foot psoriasis Be a candidate for systemic therapy in the opinion of the investigator Be naive to efalizumab treatment Weigh no more than 125 kg For women of childbearing potential, use a method of contraception acceptable to the investigator to prevent pregnancy and agree to continue to practice an acceptable method of contraception for the duration of their participation in the study and for 6 weeks after the last dose of efalizumab Exclusion Criteria: Have a history of hypersensitivity to efalizumab or any of its components Are using any excluded therapy Have a history of or ongoing alcohol or illegal drug abuse Have a history of or an ongoing uncontrolled serious bacterial, viral, fungal, or atypical mycobacterial infection. This includes diagnoses that required more than 2 weeks of therapy, such as endocarditis and osteomyelitis, that have been treated in the past 6 months. In addition, if the patient is currently receiving antibiotics, antivirals, or antifungals for an infection or for suppression or prophylaxis for any diagnosis, the patient will be excluded. Have any history of opportunistic infections (e.g., systemic fungal infections, parasites) Are seropositive for hepatitis B antigen, hepatitis C antibody, or human immunodeficiency virus (HIV). Patients will undergo testing during screening, and any patients who are seropositive for hepatitis B antigen, hepatitis C antibody, or HIV will be excluded. Have a history of active tuberculosis or are currently undergoing treatment for tuberculosis. A purified protein derivative (PPD) test or chest x-ray will be performed at the screening visit. Patients with a positive PPD test (not due to BCG vaccination) or chest x-ray will be excluded. Have the presence or history of malignancy within the past 5 years, including lymphoproliferative disorders. Patients with a history of fully resolved basal or squamous cell skin cancer may be enrolled. Are pregnant or lactating women Have a diagnosis of hepatic cirrhosis, regardless of cause or severity Have a history of thrombocytopenia Have a history of hemolytic anemia Have a history of clinically significant anemia Have a WBC count <4,000 cells/uL or >14,000 cells/uL Have a hematocrit (HCT) <30% or a hemoglobin (Hgb) level <11 g/dL Have a platelet count <150,000 cells/uL Have hepatic enzyme levels ≥3 times the upper limit of normal Have a serum creatinine level ≥2 times the upper limit of normal Have been exposed to any experimental drugs or treatments within 30 days or 5 half-lives, whichever is longer, prior to the screening visit Have had any previous exposure to efalizumab Have been vaccinated with a live virus or live bacteria within the 14 days prior to the first dose of efalizumab Have any medical condition that, in the judgment of the investigator, would jeopardize the patient's safety following exposure to study drug (efalizumab or placebo equivalent) or would significantly interfere with the patient's ability to comply with the provisions of this protocol

Sites / Locations

    Outcomes

    Primary Outcome Measures

    The primary efficacy outcome measure is the proportion of patients who achieve a PGA rating of clear (0), almost clear (1), or mild (2) at Day 84.

    Secondary Outcome Measures

    The proportion of patients who achieve a PGA rating of clear (0), almost clear (1), or mild (2) at Day 42
    The proportion of patients who achieve a PGA rating of clear (0) or almost clear (1) at Day 84
    The change from Day 0 to Day 84 in the following PRO measures: SF 36, PDS, Work Loss Questionnaire
    The change from Day 0 in PGA rating (i.e., the number of categories changed) at Day 84

    Full Information

    First Posted
    April 5, 2006
    Last Updated
    February 13, 2017
    Sponsor
    Genentech, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00312026
    Brief Title
    A Study to Evaluate the Safety and Efficacy of Efalizumab in Adult Patients With Plaque Psoriasis Involving the Hands and/or Feet
    Official Title
    A Phase IV Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of 1.0 mg/kg Efalizumab in Adult Patients With Moderate to Severe Plaque Psoriasis Involving the Hands and/or Feet
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    March 30, 2006 (undefined)
    Primary Completion Date
    November 28, 2006 (Actual)
    Study Completion Date
    November 28, 2006 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Genentech, Inc.

    4. Oversight

    5. Study Description

    Brief Summary
    This is a Phase IV randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of SC efalizumab in adult patients (18 years of age and older) with chronic moderate to severe plaque psoriasis involving the hands and/or feet who have had no previous exposure to efalizumab. The study will consist of a screening period, a treatment period, and an observation period.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Psoriasis
    Keywords
    Plaque Psoriasis, Hands, Feet, Hand

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    Double
    Allocation
    Randomized
    Enrollment
    75 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    efalizumab
    Primary Outcome Measure Information:
    Title
    The primary efficacy outcome measure is the proportion of patients who achieve a PGA rating of clear (0), almost clear (1), or mild (2) at Day 84.
    Secondary Outcome Measure Information:
    Title
    The proportion of patients who achieve a PGA rating of clear (0), almost clear (1), or mild (2) at Day 42
    Title
    The proportion of patients who achieve a PGA rating of clear (0) or almost clear (1) at Day 84
    Title
    The change from Day 0 to Day 84 in the following PRO measures: SF 36, PDS, Work Loss Questionnaire
    Title
    The change from Day 0 in PGA rating (i.e., the number of categories changed) at Day 84

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Provide written informed consent and Health Insurance Portability and Accountability Act of 1996 (HIPAA) documents Be aged 18 years or older Have chronic (6 months or greater) moderate to severe plaque psoriasis involving the hands and/or feet with or without pustules and with or without psoriasis at other sites Have a PGA rating of moderate (3) or severe (4) for hand and/or foot psoriasis Be a candidate for systemic therapy in the opinion of the investigator Be naive to efalizumab treatment Weigh no more than 125 kg For women of childbearing potential, use a method of contraception acceptable to the investigator to prevent pregnancy and agree to continue to practice an acceptable method of contraception for the duration of their participation in the study and for 6 weeks after the last dose of efalizumab Exclusion Criteria: Have a history of hypersensitivity to efalizumab or any of its components Are using any excluded therapy Have a history of or ongoing alcohol or illegal drug abuse Have a history of or an ongoing uncontrolled serious bacterial, viral, fungal, or atypical mycobacterial infection. This includes diagnoses that required more than 2 weeks of therapy, such as endocarditis and osteomyelitis, that have been treated in the past 6 months. In addition, if the patient is currently receiving antibiotics, antivirals, or antifungals for an infection or for suppression or prophylaxis for any diagnosis, the patient will be excluded. Have any history of opportunistic infections (e.g., systemic fungal infections, parasites) Are seropositive for hepatitis B antigen, hepatitis C antibody, or human immunodeficiency virus (HIV). Patients will undergo testing during screening, and any patients who are seropositive for hepatitis B antigen, hepatitis C antibody, or HIV will be excluded. Have a history of active tuberculosis or are currently undergoing treatment for tuberculosis. A purified protein derivative (PPD) test or chest x-ray will be performed at the screening visit. Patients with a positive PPD test (not due to BCG vaccination) or chest x-ray will be excluded. Have the presence or history of malignancy within the past 5 years, including lymphoproliferative disorders. Patients with a history of fully resolved basal or squamous cell skin cancer may be enrolled. Are pregnant or lactating women Have a diagnosis of hepatic cirrhosis, regardless of cause or severity Have a history of thrombocytopenia Have a history of hemolytic anemia Have a history of clinically significant anemia Have a WBC count <4,000 cells/uL or >14,000 cells/uL Have a hematocrit (HCT) <30% or a hemoglobin (Hgb) level <11 g/dL Have a platelet count <150,000 cells/uL Have hepatic enzyme levels ≥3 times the upper limit of normal Have a serum creatinine level ≥2 times the upper limit of normal Have been exposed to any experimental drugs or treatments within 30 days or 5 half-lives, whichever is longer, prior to the screening visit Have had any previous exposure to efalizumab Have been vaccinated with a live virus or live bacteria within the 14 days prior to the first dose of efalizumab Have any medical condition that, in the judgment of the investigator, would jeopardize the patient's safety following exposure to study drug (efalizumab or placebo equivalent) or would significantly interfere with the patient's ability to comply with the provisions of this protocol
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ivor Caro, M.D.
    Organizational Affiliation
    Genentech, Inc.
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    A Study to Evaluate the Safety and Efficacy of Efalizumab in Adult Patients With Plaque Psoriasis Involving the Hands and/or Feet

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