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The Safety and Utility of Skin Testing With XOLAIR® (Omalizumab) and Placebo Omalizumab (Formulation Excipients)

Primary Purpose

Healthy, Asthma

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Cohort I
Cohort 2
Sponsored by
Genentech, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Healthy focused on measuring Xolair, Asthma, Skin Tests

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • (Applicable to healthy subjects only) Healthy subjects not taking any regular prescription medication, without history of allergy, and considered healthy by the physician
  • (Applicable to asthma patients only) Patients with atopic asthma diagnosed by a physician with asthma and history of positive skin test(s)
  • Physical examination findings within normal limits
  • Body mass index (BMI) between 18 and 30, inclusive

Exclusion Criteria:

  • Pregnancy and lactation
  • Current or previous treatment with a biologic agent (e.g., monoclonal antibody)
  • Concurrent disease or condition that would interfere, or for which the treatment might interfere with the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to individuals in this study
  • History or symptoms of significant psychiatric disease, including but not limited to, depression, schizophrenia, etc.
  • History of drug abuse
  • Participation in an investigational drug or device trial within the last 30 days prior to screening

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Healthy Volunteers

    Allergic Asthma Participants

    Arm Description

    Healthy participants were tested sequentially in a skin prick test procedure with positive control (histamine 6 mg/mL), negative control (saline), and 1:1000, 1:100, 1:10 dilution and full concentrations of both omalizumab and omalizumab excipients.

    Allergic asthma participants were tested sequentially in a skin prick test procedure with positive control (histamine 6 mg/mL), negative control (saline), and a succession of 1:1000, 1:100, 1:10 dilutions and full concentration of both omalizumab and omalizumab excipients.

    Outcomes

    Primary Outcome Measures

    Number of Participants by of Adverse Events Following a Skin Test Procedure
    Skin test procedures were skin prick test or intradermal test. The test started with the lowest concentration. If a positive skin reaction was observed, escalation to the next dilution was stopped. Subjects were observed for 20 minutes following each test; subjects were observed for 1 hour after the last intradermal test. Those with a positive response were observed for an additional 6 hours. Severity refers to the intensity of an AE (mild, moderate or severe). Mild is itching or hives, for example. A severe event requires emergency medical treatment and can result in death.
    Number of Participants Who Experienced a Positive Skin Reaction (Skin Prick Test)
    For skin prick, positive control (histamine 6 mg/mL) and negative control (saline) were used. Positive skin reaction was defined as a ≥ 3-mm wheal and/or > 10-mm erythema from negative control. The skin prick test started with the lowest concentration. If a positive skin reaction was observed, escalation to the next dilution was stopped.
    Number of Participants Who Experienced a Positive Skin Reaction (Intradermal Test in Healthy Volunteers)
    For intradermal testing, positive control (histamine 0.1 mg/mL) and negative control (saline) were used. Positive skin reaction was defined as a ≥ 3-mm wheal and/or > 10-mm erythema from negative control. The intradermal test started with the lowest concentration. If a positive skin reaction was observed, escalation to the next dilution was stopped.
    Number of Participants Who Experienced a Positive Skin Reaction (Intradermal Test in Patients With Allergic Asthma)
    For intradermal testing, positive control (histamine 0.1 mg/mL) and negative control (saline) were used. Positive skin reaction was defined as a ≥ 3-mm wheal and/or > 10-mm erythema from negative control. The intradermal test started with the lowest concentration. If a positive skin reaction was observed, escalation to the next dilution was stopped.

    Secondary Outcome Measures

    Full Information

    First Posted
    October 21, 2008
    Last Updated
    May 16, 2017
    Sponsor
    Genentech, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00777764
    Brief Title
    The Safety and Utility of Skin Testing With XOLAIR® (Omalizumab) and Placebo Omalizumab (Formulation Excipients)
    Official Title
    The Safety and Utility of Skin Testing With XOLAIR® (Omalizumab) and Placebo Omalizumab (Formulation Excipients)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2008 (Actual)
    Primary Completion Date
    April 2009 (Actual)
    Study Completion Date
    April 2009 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    5. Study Description

    Brief Summary
    This study enrolled 30 healthy volunteers and 30 patients with atopic asthma, for a total of 60 subjects. The study examined the tolerability of omalizumab and omalizumab excipients in two successive cohorts of subjects, healthy volunteers and patients with allergic asthma without prior exposure to omalizumab, according to a skin test protocol, consisting of a prick skin test and/or intradermal test.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Healthy, Asthma
    Keywords
    Xolair, Asthma, Skin Tests

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    60 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Healthy Volunteers
    Arm Type
    Experimental
    Arm Description
    Healthy participants were tested sequentially in a skin prick test procedure with positive control (histamine 6 mg/mL), negative control (saline), and 1:1000, 1:100, 1:10 dilution and full concentrations of both omalizumab and omalizumab excipients.
    Arm Title
    Allergic Asthma Participants
    Arm Type
    Experimental
    Arm Description
    Allergic asthma participants were tested sequentially in a skin prick test procedure with positive control (histamine 6 mg/mL), negative control (saline), and a succession of 1:1000, 1:100, 1:10 dilutions and full concentration of both omalizumab and omalizumab excipients.
    Intervention Type
    Drug
    Intervention Name(s)
    Cohort I
    Intervention Description
    In sterile water for injection (SWFI), full concentration and 1:1000, 1:100, 1:10 dilutions of 125 mg/mL of standard solution of omalizumab and its excipients. Skin prick test of each dilution concentration of 1:1000, 1:100, 1:10 and full concentration and Intradermal tests of each dilution concentration of 1:1000, 1:100 and 1:10 were followed by 20 minutes of observation. For the skin prick test, participants were tested initially with positive control (histamine 6 mg/mL) and negative control (saline), and with omalizumab and its excipients simultaneously from the lowest concentration. For the intradermal test, participants were tested initially with positive control (histamine 0.1 mg/mL) and negative control (saline), and with omalizumab and its excipients simultaneously from the lowest concentration. Dilutions of omalizumab and its excipients were in SWFI.
    Intervention Type
    Drug
    Intervention Name(s)
    Cohort 2
    Intervention Description
    In a saline solution, full concentration and 1:1000, 1:100, 1:10 dilutions of 125 mg/mL of standard solution of omalizumab and its excipients. Skin prick test of each dilution concentration of 1:1000, 1:100, 1:10 and full concentration and Intradermal tests of each dilution concentration of 1:100,000 and 1:10,000 were followed by 20 minutes of observation. For the skin prick test, participants were tested initially by positive control (histamine 6 mg/mL) and negative control (saline), and with omalizumab and its excipients simultaneously from the lowest concentration. For the intradermal test, participants were tested initially with positive control (histamine 0.1 mg/mL) and negative control (saline), and with omalizumab and its excipients simultaneously from the lowest concentration. Dilutions of omalizumab and its excipients were made in saline.
    Primary Outcome Measure Information:
    Title
    Number of Participants by of Adverse Events Following a Skin Test Procedure
    Description
    Skin test procedures were skin prick test or intradermal test. The test started with the lowest concentration. If a positive skin reaction was observed, escalation to the next dilution was stopped. Subjects were observed for 20 minutes following each test; subjects were observed for 1 hour after the last intradermal test. Those with a positive response were observed for an additional 6 hours. Severity refers to the intensity of an AE (mild, moderate or severe). Mild is itching or hives, for example. A severe event requires emergency medical treatment and can result in death.
    Time Frame
    Up to 7 days following skin testing
    Title
    Number of Participants Who Experienced a Positive Skin Reaction (Skin Prick Test)
    Description
    For skin prick, positive control (histamine 6 mg/mL) and negative control (saline) were used. Positive skin reaction was defined as a ≥ 3-mm wheal and/or > 10-mm erythema from negative control. The skin prick test started with the lowest concentration. If a positive skin reaction was observed, escalation to the next dilution was stopped.
    Time Frame
    on the day of skin test
    Title
    Number of Participants Who Experienced a Positive Skin Reaction (Intradermal Test in Healthy Volunteers)
    Description
    For intradermal testing, positive control (histamine 0.1 mg/mL) and negative control (saline) were used. Positive skin reaction was defined as a ≥ 3-mm wheal and/or > 10-mm erythema from negative control. The intradermal test started with the lowest concentration. If a positive skin reaction was observed, escalation to the next dilution was stopped.
    Time Frame
    on the day of skin test
    Title
    Number of Participants Who Experienced a Positive Skin Reaction (Intradermal Test in Patients With Allergic Asthma)
    Description
    For intradermal testing, positive control (histamine 0.1 mg/mL) and negative control (saline) were used. Positive skin reaction was defined as a ≥ 3-mm wheal and/or > 10-mm erythema from negative control. The intradermal test started with the lowest concentration. If a positive skin reaction was observed, escalation to the next dilution was stopped.
    Time Frame
    on the day of skin test

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: (Applicable to healthy subjects only) Healthy subjects not taking any regular prescription medication, without history of allergy, and considered healthy by the physician (Applicable to asthma patients only) Patients with atopic asthma diagnosed by a physician with asthma and history of positive skin test(s) Physical examination findings within normal limits Body mass index (BMI) between 18 and 30, inclusive Exclusion Criteria: Pregnancy and lactation Current or previous treatment with a biologic agent (e.g., monoclonal antibody) Concurrent disease or condition that would interfere, or for which the treatment might interfere with the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to individuals in this study History or symptoms of significant psychiatric disease, including but not limited to, depression, schizophrenia, etc. History of drug abuse Participation in an investigational drug or device trial within the last 30 days prior to screening
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Dennis Wong, M.D.
    Organizational Affiliation
    Genentech, Inc.
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    The Safety and Utility of Skin Testing With XOLAIR® (Omalizumab) and Placebo Omalizumab (Formulation Excipients)

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