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A Study to Evaluate MILR1444A in the Prevention of Allergen-Induced Airway Obstruction in Adults With Mild Allergic Asthma

Primary Purpose

Allergic Asthma

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
lebrikizumab (MILR1444A)
placebo
Sponsored by
Genentech, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Allergic Asthma focused on measuring Asthma

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Meet criteria for the diagnosis of allergic asthma
  • Diagnosis of asthma ≥ 6 months
  • Currently treated with only intermittent short-acting inhaled β-adrenergic agonists
  • Body weight between 40-120 kg
  • Normal chest X-ray within 2 years of screening

Exclusion Criteria:

  • Require daily controller medication for asthma
  • History of hypersensitivity to the study drug or to drugs with similar chemical structures or to any ingredients, including excipients of the study medication or drugs related to MILR1444A (e.g., monoclonal antibodies, polyclonal gamma globulin)
  • Documented medical history of anaphylaxis
  • Immunotherapy currently or within the past 3 months prior to screening
  • Lung disease other than mild allergic asthma
  • Previous treatment with other investigational drugs within 30 days or 5 half-lives prior to the screening visit, whichever is longer
  • Pregnant or lactating
  • Significant concurrent medical illness other than asthma
  • Clinically significant abnormality on ECG at the screening visit
  • Smoked in the previous 6 months or have a history of smoking more than 10 pack-years
  • History of helminthic infection

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    A

    B

    Arm Description

    Outcomes

    Primary Outcome Measures

    Late asthmatic response (LAR)

    Secondary Outcome Measures

    Early asthmatic response (EAR)

    Full Information

    First Posted
    October 27, 2008
    Last Updated
    May 4, 2010
    Sponsor
    Genentech, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00781443
    Brief Title
    A Study to Evaluate MILR1444A in the Prevention of Allergen-Induced Airway Obstruction in Adults With Mild Allergic Asthma
    Official Title
    A Phase II, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MILR1444A in the Prevention of Allergen-Induced Airway Obstruction in Adults With Mild Allergic Asthma
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2010
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2008 (undefined)
    Primary Completion Date
    November 2009 (Actual)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Genentech, Inc.

    4. Oversight

    5. Study Description

    Brief Summary
    This is a multicenter, randomized, double-blind, placebo-controlled study designed to demonstrate the safety and efficacy of MILR1444A compared with placebo in reducing the airway reaction to an inhaled aeroallergen solution in adult patients with mild allergic asthma. The study will randomize approximately 24 patients at five study centers. In the event of patient discontinuation from the study, additional patients may be enrolled at the discretion of the Sponsor.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Allergic Asthma
    Keywords
    Asthma

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare Provider
    Allocation
    Randomized
    Enrollment
    29 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    A
    Arm Type
    Experimental
    Arm Title
    B
    Arm Type
    Placebo Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    lebrikizumab (MILR1444A)
    Intervention Description
    Repeating subcutaneous injection
    Intervention Type
    Drug
    Intervention Name(s)
    placebo
    Intervention Description
    Repeating subcutaneous injection
    Primary Outcome Measure Information:
    Title
    Late asthmatic response (LAR)
    Time Frame
    Day 92
    Secondary Outcome Measure Information:
    Title
    Early asthmatic response (EAR)
    Time Frame
    Day 92

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    55 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Meet criteria for the diagnosis of allergic asthma Diagnosis of asthma ≥ 6 months Currently treated with only intermittent short-acting inhaled β-adrenergic agonists Body weight between 40-120 kg Normal chest X-ray within 2 years of screening Exclusion Criteria: Require daily controller medication for asthma History of hypersensitivity to the study drug or to drugs with similar chemical structures or to any ingredients, including excipients of the study medication or drugs related to MILR1444A (e.g., monoclonal antibodies, polyclonal gamma globulin) Documented medical history of anaphylaxis Immunotherapy currently or within the past 3 months prior to screening Lung disease other than mild allergic asthma Previous treatment with other investigational drugs within 30 days or 5 half-lives prior to the screening visit, whichever is longer Pregnant or lactating Significant concurrent medical illness other than asthma Clinically significant abnormality on ECG at the screening visit Smoked in the previous 6 months or have a history of smoking more than 10 pack-years History of helminthic infection
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Edward Conner, M.D.
    Organizational Affiliation
    Genentech, Inc.
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    24131304
    Citation
    Scheerens H, Arron JR, Zheng Y, Putnam WS, Erickson RW, Choy DF, Harris JM, Lee J, Jarjour NN, Matthews JG. The effects of lebrikizumab in patients with mild asthma following whole lung allergen challenge. Clin Exp Allergy. 2014 Jan;44(1):38-46. doi: 10.1111/cea.12220.
    Results Reference
    derived

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    A Study to Evaluate MILR1444A in the Prevention of Allergen-Induced Airway Obstruction in Adults With Mild Allergic Asthma

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