<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/NCT01728298</url>
  </required_header>
  <id_info>
    <org_study_id>SU-M-01</org_study_id>
    <nct_id>NCT01728298</nct_id>
  </id_info>
  <brief_title>A Dose Response Evaluation of SLITone Ultra HDM Mix Immunotherapy</brief_title>
  <acronym>SUMMIT</acronym>
  <official_title>A Dose Response Evaluation of SLITone Ultra HDM Mix Immunotherapy - The SUMMIT Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>ALK-Abelló A/S</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>ALK-Abelló A/S</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective of the trial is to evaluate the dose-response relationship with regards&#xD;
      to change in immunological parameters and safety for SLITone ULTRA house dust mite mix in&#xD;
      adult subjects with moderate to severe HDM allergic rhinitis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">August 2013</completion_date>
  <primary_completion_date type="Actual">August 2013</primary_completion_date>
  <phase>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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline in IgE-blocking factor after 6 months of treatment</measure>
    <time_frame>6 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of subjects with treatment related adverse events</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">219</enrollment>
  <condition>Allergic Rhinitis</condition>
  <arm_group>
    <arm_group_label>SLITone ULTRA low dose</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>SLITone ULTRA HDM immunotherapy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SLITone ULTRA medium dose</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>SLITone ULTRA HDM immunotherapy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SLITone ULTRA high dose</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>SLITone ULTRA HDM immunotherapy</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>SLITone ULTRA HDM immunotherapy</intervention_name>
    <arm_group_label>SLITone ULTRA high dose</arm_group_label>
    <arm_group_label>SLITone ULTRA low dose</arm_group_label>
    <arm_group_label>SLITone ULTRA medium dose</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Aged 18 or older&#xD;
&#xD;
          -  Moderate to severe persistent HDM allergic rhinitis with or without asthma&#xD;
&#xD;
          -  Moderate to severe HDM allergic rhinitis symptoms during a baseline period&#xD;
&#xD;
          -  Positive skin prick test response (wheal diameter ≥ 3 mm)&#xD;
&#xD;
          -  Positive specific IgE ≥ IgE Class 2, ≥ 0.70 kU/l)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous treatment with immunotherapy with House dust mite immunotherapy&#xD;
&#xD;
          -  Ongoing treatment with any allergen specific immunotherapy product&#xD;
&#xD;
          -  Reduced lung function&#xD;
&#xD;
          -  Clinical history of uncontrolled asthma&#xD;
&#xD;
          -  Inflammatory conditions in the oral cavity with severe symptoms&#xD;
&#xD;
          -  History of anaphylaxis with cardiorespiratory symptoms&#xD;
&#xD;
          -  History of recurrent generalised urticaria&#xD;
&#xD;
          -  A history of drug induced facial angioedema or hereditary angiooedema&#xD;
&#xD;
          -  Any clinically relevant chronic disease (≥3 months duration)&#xD;
&#xD;
          -  Systemic disease affecting the immune system&#xD;
&#xD;
          -  Immunosuppressive treatment&#xD;
&#xD;
          -  Currently treated with tricyclic antidepressants; catecholamine-Methyltransferase&#xD;
             inhibitors and mono amine oxidase inhibitors&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Alain Didier, Pr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hôpital Larrey, Toulouse</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Proffesor Alain Didier</name>
      <address>
        <city>Toulouse</city>
        <zip>31059</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>January 2014</verification_date>
  <study_first_submitted>November 2, 2012</study_first_submitted>
  <study_first_submitted_qc>November 14, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 19, 2012</study_first_posted>
  <last_update_submitted>January 20, 2014</last_update_submitted>
  <last_update_submitted_qc>January 20, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 22, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>House Dust Mite</keyword>
  <keyword>allergy</keyword>
  <keyword>rhinitis</keyword>
  <keyword>asthma</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rhinitis</mesh_term>
    <mesh_term>Rhinitis, Allergic</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Immunomodulating Agents</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/NCT01728298
org study id: SU-M-01
nct id: NCT01728298
lead sponsor: 
has dmc: No
The primary objective of the trial is to evaluate the dose-response relationship with regards
      to change in immunological parameters and safety for SLITone ULTRA house dust mite mix in
      adult subjects with moderate to severe HDM allergic rhinitis.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change from baseline in IgE-blocking factor after 6 months of treatment
time frame: 6 months
measure: Number of subjects with treatment related adverse events
time frame: 6 months
arm group label: SLITone ULTRA low dose
arm group type: Active Comparator
description: SLITone ULTRA HDM immunotherapy
arm group label: SLITone ULTRA medium dose
arm group type: Active Comparator
description: SLITone ULTRA HDM immunotherapy
arm group label: SLITone ULTRA high dose
arm group type: Active Comparator
description: SLITone ULTRA HDM immunotherapy
intervention type: Biological
intervention name: SLITone ULTRA HDM immunotherapy
arm group label: SLITone ULTRA high dose
arm group label: SLITone ULTRA low dose
arm group label: SLITone ULTRA medium dose
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Alain Didier, Pr.
role: Principal Investigator
affiliation: Hôpital Larrey, Toulouse
facility: 
country: France
responsible party type: Sponsor
mesh term: Rhinitis
mesh term: Rhinitis, Allergic
mesh term: Immunomodulating Agents