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Safety and Efficacy of QAX576 in Adults With Moderate Persistent Allergic Asthma

Primary Purpose

Asthma

Status
Withdrawn
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
QAX576
Placebo
Sponsored by
Novartis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma focused on measuring Asthma, interleukin-13

Eligibility Criteria

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

Inclusion Criteria:

  • History of asthma attacks
  • Taking inhaled corticosteroids
  • Non-smoking

Exclusion Criteria:

  • Women of child-bearing potential
  • History of respiratory disease other than asthma
  • History of severe allergy to food or drugs
  • Previous use of monoclonal antibodies
  • Very low or high body weight

Other protocol-defined inclusion/exclusion criteria may apply.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    1

    2

    Arm Description

    Outcomes

    Primary Outcome Measures

    - Forced expiratory volume in 1 second (FEV1)at baseline and until study completion - Levels of eosinophils in sputum

    Secondary Outcome Measures

    - Three doses of QAX576 on time to treatment failure, plasma IL-13 levels and immunogenicity in asthmatics - Sputum biomarkers

    Full Information

    First Posted
    January 9, 2008
    Last Updated
    March 2, 2016
    Sponsor
    Novartis
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00598104
    Brief Title
    Safety and Efficacy of QAX576 in Adults With Moderate Persistent Allergic Asthma
    Official Title
    A Randomized, Double-blinded, Placebo Controlled, Parallel Group, Multi-center Study to Assess Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of Intravenous Doses of QAX576 in Moderate Persistent Allergic Asthmatics Following Inhaled Corticosteroid Withdrawal
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2016
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Due to the lack of enrolment and complexity of design, this study in asthma was terminated. No subjects have been dosed for this study.
    Study Start Date
    January 2008 (undefined)
    Primary Completion Date
    December 2008 (Actual)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Novartis

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This study will evaluate the safety and efficacy of QAX576 against asthma attacks in adults with moderate persistent allergic asthma

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Asthma
    Keywords
    Asthma, interleukin-13

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1, Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Experimental
    Arm Title
    2
    Arm Type
    Placebo Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    QAX576
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Primary Outcome Measure Information:
    Title
    - Forced expiratory volume in 1 second (FEV1)at baseline and until study completion - Levels of eosinophils in sputum
    Time Frame
    Throughout the study
    Secondary Outcome Measure Information:
    Title
    - Three doses of QAX576 on time to treatment failure, plasma IL-13 levels and immunogenicity in asthmatics - Sputum biomarkers
    Time Frame
    Throughout the study

    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: History of asthma attacks Taking inhaled corticosteroids Non-smoking Exclusion Criteria: Women of child-bearing potential History of respiratory disease other than asthma History of severe allergy to food or drugs Previous use of monoclonal antibodies Very low or high body weight Other protocol-defined inclusion/exclusion criteria may apply.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    NOVARTIS
    Organizational Affiliation
    Novartis investigative site
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Safety and Efficacy of QAX576 in Adults With Moderate Persistent Allergic Asthma

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