<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01703312</url>
  </required_header>
  <id_info>
    <org_study_id>CQGE031B2203</org_study_id>
    <nct_id>NCT01703312</nct_id>
  </id_info>
  <brief_title>A Study Evaluating the Efficacy of QGE031 Compared to Omalizumab in Patients With Allergic Asthma</brief_title>
  <official_title>A Randomized, Double-blind, Placebo- and Comparator-controlled Study Evaluating the Effect of Multiple Doses of QGE031 Compared to Omalizumab in Asthma Induced by Allergen Bronchial Provocation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Novartis Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Novartis</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will evaluate the efficacy of QGE031 compared to omalizumab in patients with&#xD;
      allergic asthma. Each treatment's effect in changing the concentration of inhaled allergen&#xD;
      that is required to elicit a 15% fall in the forced expiratory volume in one second (FEV1) at&#xD;
      12 weeks compared to baseline will be evaluated.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">October 2013</completion_date>
  <primary_completion_date type="Actual">October 2013</primary_completion_date>
  <phase>Phase 1/Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in the concentration of inhaled allergen that elicits a 15% fall in the forced expiratory volume in one second (FEV1)</measure>
    <time_frame>Baseline, 12 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in the concentration of inhaled allergen that elicits a 15% fall in the forced expiratory volume in one second (FEV1) following treatment with placebo and various doses of QGE031</measure>
    <time_frame>Baseline, 12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>QGE031 blood concentrations</measure>
    <time_frame>24 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with adverse events or other safety concerns</measure>
    <time_frame>24 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">37</enrollment>
  <condition>Allergic Asthma</condition>
  <arm_group>
    <arm_group_label>QGE031</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>During the 10-week treatment period, participants will receive a dose of study drug subcutaneously once every two weeks (total of six doses). Three dose levels of QGE031 will be offered during the study: low, medium, and high. Participants will be randomized to receive one of these dose levels for all dosing visits.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>omalizumab</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>During the 10-week treatment period, participants will receive a dose of study drug subcutaneously once every two weeks (total of six doses) or once every four weeks (total of three doses). The dose that a participant receives will depend upon the participant's body weight and IgE level; dosage will be determined based upon local omalizumab dosing charts.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>During the 10-week treatment period, participants will receive a dose of study drug subcutaneously once every two weeks (total of six doses).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>QGE031</intervention_name>
    <description>Drug administered by subcutaneous injection</description>
    <arm_group_label>QGE031</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>omalizumab</intervention_name>
    <description>Drug administered by subcutaneous injection</description>
    <arm_group_label>omalizumab</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>placebo</intervention_name>
    <description>Drug administered by subcutaneous injection</description>
    <arm_group_label>placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Adult patients 18 to 65 years&#xD;
&#xD;
        Positive skin prick test to one or more common airborne allergens&#xD;
&#xD;
        Presence of airway hyperresponsiveness documented by a provocative concentration of&#xD;
        methacholine causing a 20% fall in FEV1 (PC20 FEV1) of less than or equal to 16 mg/mL&#xD;
&#xD;
        Presence of an early asthmatic response demonstrated by an allergen challenge at screening&#xD;
        and including a 15% fall in the FEV1&#xD;
&#xD;
        Patients with a body weight and total IgE in a range specified by local country prescribing&#xD;
        information for omalizumab&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Pregnant or nursing (lactating) women&#xD;
&#xD;
        Women of child-bearing potential unless they are using a highly effective method of birth&#xD;
        control (as further defined in the study protocol)&#xD;
&#xD;
        Smokers&#xD;
&#xD;
        Patients with poorly controlled asthma or patients who have had an asthma exacerbation&#xD;
        within the past year&#xD;
&#xD;
        Other protocol-defined inclusion/exclusion criteria may apply.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Novartis Pharmaceuticals</last_name>
    <role>Study Director</role>
    <affiliation>Novartis Pharmaceuticals</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Calgary</city>
        <state>Alberta</state>
        <zip>T2N 4N1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Edmonton</city>
        <state>Alberta</state>
        <zip>T6G 2B7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Hamilton</city>
        <state>Ontario</state>
        <zip>L8N 3Z5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Ste-Foy</city>
        <state>Quebec</state>
        <zip>G1V 4G5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Saskatoon</city>
        <state>Saskatchewan</state>
        <zip>S7N 0W8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Vancouver</city>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Stockholm</city>
        <zip>S-171 76</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>Sweden</country>
  </location_countries>
  <verification_date>April 2016</verification_date>
  <study_first_submitted>October 5, 2012</study_first_submitted>
  <study_first_submitted_qc>October 5, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 10, 2012</study_first_posted>
  <last_update_submitted>April 19, 2016</last_update_submitted>
  <last_update_submitted_qc>April 19, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 20, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Allergies, asthma, IgE</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Asthma</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Omalizumab</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01703312
org study id: CQGE031B2203
nct id: NCT01703312
lead sponsor: 
has dmc: No
This study will evaluate the efficacy of QGE031 compared to omalizumab in patients with
      allergic asthma. Each treatment's effect in changing the concentration of inhaled allergen
      that is required to elicit a 15% fall in the forced expiratory volume in one second (FEV1) at
      12 weeks compared to baseline will be evaluated.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Change in the concentration of inhaled allergen that elicits a 15% fall in the forced expiratory volume in one second (FEV1)
time frame: Baseline, 12 weeks
measure: Change in the concentration of inhaled allergen that elicits a 15% fall in the forced expiratory volume in one second (FEV1) following treatment with placebo and various doses of QGE031
time frame: Baseline, 12 weeks
measure: QGE031 blood concentrations
time frame: 24 weeks
measure: Number of participants with adverse events or other safety concerns
time frame: 24 weeks
arm group label: QGE031
arm group type: Experimental
description: During the 10-week treatment period, participants will receive a dose of study drug subcutaneously once every two weeks (total of six doses). Three dose levels of QGE031 will be offered during the study: low, medium, and high. Participants will be randomized to receive one of these dose levels for all dosing visits.
arm group label: omalizumab
arm group type: Active Comparator
description: During the 10-week treatment period, participants will receive a dose of study drug subcutaneously once every two weeks (total of six doses) or once every four weeks (total of three doses). The dose that a participant receives will depend upon the participant's body weight and IgE level; dosage will be determined based upon local omalizumab dosing charts.
arm group label: placebo
arm group type: Placebo Comparator
description: During the 10-week treatment period, participants will receive a dose of study drug subcutaneously once every two weeks (total of six doses).
intervention type: Drug
intervention name: QGE031
description: Drug administered by subcutaneous injection
arm group label: QGE031
intervention type: Drug
intervention name: omalizumab
description: Drug administered by subcutaneous injection
arm group label: omalizumab
intervention type: Drug
intervention name: placebo
description: Drug administered by subcutaneous injection
arm group label: placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Novartis Pharmaceuticals
role: Study Director
affiliation: Novartis Pharmaceuticals
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Canada
country: Sweden
responsible party type: Sponsor
mesh term: Asthma
mesh term: Omalizumab