<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/NCT01675791</url>
  </required_header>
  <id_info>
    <org_study_id>TT-02</org_study_id>
    <nct_id>NCT01675791</nct_id>
  </id_info>
  <brief_title>A Dose-response Evaluation of ALK (the Sponsor) Tree Allergy Immunotherapy Tablet</brief_title>
  <official_title>A Dose-response Evaluation of ALK Tree AIT</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 aim of this trial is to evaluate the dose-response relationship for the ALK tree&#xD;
      AIT administered once daily in order to define a dose-range that would be suitable for&#xD;
      at-home administration.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">September 2013</completion_date>
  <primary_completion_date type="Actual">July 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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Allergy symptom severity scores on a scale from 0-3</measure>
    <time_frame>During the birch pollen season 2013, an expected average of 3 weeks</time_frame>
    <description>Determine the dose-efficacy response relationship of the ALK tree AIT. This information will, in combination with the evaluation of the frequency and severity of adverse events, form the basis of the conclusion on the primary endpoint.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Adverse events frequency</measure>
    <time_frame>Throughout the trial, an expected average of 8 months</time_frame>
    <description>Determine the dose-safety response relationship of the ALK tree AIT. This information will, in combination with the evaluation of the allergy symptoms, form the basis of the conclusion on the primary endpoint.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Adverse events severity</measure>
    <time_frame>Throughout the trial, an expected average of 8 months</time_frame>
    <description>Determine the dose-safety response relationship of the ALK tree AIT. This information will, in combination with the evaluation of the allergy symptoms, form the basis of the conclusion on the primary endpoint.</description>
  </secondary_outcome>
  <number_of_arms>7</number_of_arms>
  <enrollment type="Actual">637</enrollment>
  <condition>Birch Pollen Allergy</condition>
  <arm_group>
    <arm_group_label>ALK tree AIT Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>1 AIT administered sublingually every day</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ALK tree AIT 0.5 DU</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>1 AIT administered sublingually every day</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ALK tree AIT 1 DU</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>1 AIT administered sublingually every day</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ALK tree AIT 2 DU</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>1 AIT administered sublingually every day</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ALK tree AIT 4 DU</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>1 AIT administered sublingually every day</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ALK tree AIT 7 DU</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>1 AIT administered sublingually every day</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ALK tree AIT 12 DU</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>1 AIT administered sublingually every day</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>ALK tree AIT 0.5 DU</intervention_name>
    <arm_group_label>ALK tree AIT 0.5 DU</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>ALK tree AIT 1 DU</intervention_name>
    <arm_group_label>ALK tree AIT 1 DU</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>ALK tree AIT 2 DU</intervention_name>
    <arm_group_label>ALK tree AIT 2 DU</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>ALK tree AIT 4 DU</intervention_name>
    <arm_group_label>ALK tree AIT 4 DU</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>ALK tree AIT 7 DU</intervention_name>
    <arm_group_label>ALK tree AIT 7 DU</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>ALK tree AIT 12 DU</intervention_name>
    <arm_group_label>ALK tree AIT 12 DU</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>ALK tree AIT Placebo</intervention_name>
    <arm_group_label>ALK tree AIT Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  A history of moderate to severe birch pollen allergy&#xD;
&#xD;
          -  Use of symptomatic medication for treatment of birch pollen allergy&#xD;
&#xD;
          -  Positive skin prick test to birch extract&#xD;
&#xD;
          -  Positive specific IgE against Bet v 1&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Overlapping perennial allergies&#xD;
&#xD;
          -  History of uncontrolled asthma within the last 3 months&#xD;
&#xD;
          -  FEV1 &lt; 70% of predicted value in adults or FEV1 &lt; 80% of predicted value in&#xD;
             adolescents&#xD;
&#xD;
          -  Previous or ongoing treatment with immunotherapy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Skin and Allergy Hospital, Helsinki University Central Hospital</name>
      <address>
        <city>Helsinki</city>
        <state>HUS</state>
        <zip>00029</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Slotervaart Ziekenhuis</name>
      <address>
        <city>Amsterdam</city>
        <zip>1066EC</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Finland</country>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>January 2014</verification_date>
  <study_first_submitted>August 27, 2012</study_first_submitted>
  <study_first_submitted_qc>August 29, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 30, 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>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rhinitis, Allergic, Seasonal</mesh_term>
    <mesh_term>Hypersensitivity</mesh_term>
  </condition_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/NCT01675791
org study id: TT-02
nct id: NCT01675791
lead sponsor: 
has dmc: No
The primary aim of this trial is to evaluate the dose-response relationship for the ALK tree
      AIT administered once daily in order to define a dose-range that would be suitable for
      at-home administration.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Allergy symptom severity scores on a scale from 0-3
time frame: During the birch pollen season 2013, an expected average of 3 weeks
description: Determine the dose-efficacy response relationship of the ALK tree AIT. This information will, in combination with the evaluation of the frequency and severity of adverse events, form the basis of the conclusion on the primary endpoint.
measure: Adverse events frequency
time frame: Throughout the trial, an expected average of 8 months
description: Determine the dose-safety response relationship of the ALK tree AIT. This information will, in combination with the evaluation of the allergy symptoms, form the basis of the conclusion on the primary endpoint.
measure: Adverse events severity
time frame: Throughout the trial, an expected average of 8 months
description: Determine the dose-safety response relationship of the ALK tree AIT. This information will, in combination with the evaluation of the allergy symptoms, form the basis of the conclusion on the primary endpoint.
arm group label: ALK tree AIT Placebo
arm group type: Placebo Comparator
description: 1 AIT administered sublingually every day
arm group label: ALK tree AIT 0.5 DU
arm group type: Experimental
description: 1 AIT administered sublingually every day
arm group label: ALK tree AIT 1 DU
arm group type: Experimental
description: 1 AIT administered sublingually every day
arm group label: ALK tree AIT 2 DU
arm group type: Experimental
description: 1 AIT administered sublingually every day
arm group label: ALK tree AIT 4 DU
arm group type: Experimental
description: 1 AIT administered sublingually every day
arm group label: ALK tree AIT 7 DU
arm group type: Experimental
description: 1 AIT administered sublingually every day
arm group label: ALK tree AIT 12 DU
arm group type: Experimental
description: 1 AIT administered sublingually every day
intervention type: Biological
intervention name: ALK tree AIT 0.5 DU
arm group label: ALK tree AIT 0.5 DU
intervention type: Biological
intervention name: ALK tree AIT 1 DU
arm group label: ALK tree AIT 1 DU
intervention type: Biological
intervention name: ALK tree AIT 2 DU
arm group label: ALK tree AIT 2 DU
intervention type: Biological
intervention name: ALK tree AIT 4 DU
arm group label: ALK tree AIT 4 DU
intervention type: Biological
intervention name: ALK tree AIT 7 DU
arm group label: ALK tree AIT 7 DU
intervention type: Biological
intervention name: ALK tree AIT 12 DU
arm group label: ALK tree AIT 12 DU
intervention type: Biological
intervention name: ALK tree AIT Placebo
arm group label: ALK tree AIT Placebo
criteria: 
gender: All
minimum age: 12 Years
maximum age: 65 Years
healthy volunteers: No
facility: 
facility: 
country: Finland
country: Netherlands
responsible party type: Sponsor
mesh term: Rhinitis, Allergic, Seasonal
mesh term: Hypersensitivity