<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/NCT01720251</url>
  </required_header>
  <id_info>
    <org_study_id>AN004T</org_study_id>
    <secondary_id>2011-002259-32</secondary_id>
    <nct_id>NCT01720251</nct_id>
  </id_info>
  <brief_title>Efficacy Study of a Preseasonal Treatment With AllerT in Subjects With Birch Pollen Allergy</brief_title>
  <official_title>Phase IIb Study to Assess the Efficacy, Safety and Tolerability of Two Dosing Regimens of AllerT in Comparison to Placebo in Adult Subjects Allergic to Birch Pollen</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Anergis</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Anergis</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The main objective of the trial is to demonstrate the efficacy of a two months pre-seasonal&#xD;
      treatment with AllerT 100 µg maintenance dose in reducing symptoms of allergic&#xD;
      rhinoconjunctivitis during the following birch pollen season&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">September 2013</completion_date>
  <primary_completion_date type="Actual">September 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>Combined Rhinoconjunctivitis Symptom and Medication Score</measure>
    <time_frame>up to 6 weeks during the birch pollen season 2013</time_frame>
    <description>The efficacy analysis will be performed on the symptom and medication data collected from the first day of the birch pollen season as defined by pollen counts in the air in each site region (from March to May 2013 depending on site region), to 42 days later or to the end of the pollen season, whichever comes first.&#xD;
The scale range is from 0 to 3. Lower is the the RSMS value, better is the efficacy as this implies that lower is the symptoms and concomitant medication intake by the patient The RSMS includes 2 subscales : the Rhinoconjunctivitis Symptom Score (RSS) with a range of values from 0 to 3 and the Rhinoconjunctivitis Medication Score Score (RMS) with also a range of values from 0 to 3 The RSMS is the sum of the RSS and RMS divided by 2</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quality of Life</measure>
    <time_frame>up to 6 weeks during the birch pollen season 2013</time_frame>
    <description>mini-RQLQ questionnaires</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety and Tolerability</measure>
    <time_frame>from start of treatment to 28 days after completion of treatment, i.e. for approximately 12 weeks</time_frame>
    <description>Adverse events will be collected throughout the trial period and will be reported as Treatment emergent adverse events occurring between start of treatment and 28 days after completion of treatment for each subject</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Immunological Markers: Specific IgE and IgG4</measure>
    <time_frame>before treatment, 4 weeks after the last injection and 2 weeks before, at the peak time and within 2 weeks after the end of the expected birch pollen season 2013</time_frame>
    <description>blood samples will be drawn at the above time points to measure immunological markers: specific IgE and IgG4</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">240</enrollment>
  <condition>Allergic Rhinitis</condition>
  <condition>Rhinoconjunctivitis</condition>
  <arm_group>
    <arm_group_label>placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>SC injections of placebo</description>
  </arm_group>
  <arm_group>
    <arm_group_label>AllerT low dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>SC injections of AllerT 25 or 50 micrograms</description>
  </arm_group>
  <arm_group>
    <arm_group_label>AllerT full dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>SC injections of AllerT 50-100 micrograms</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>placebo</intervention_name>
    <description>SC injections of placebo on days 1, 7, 14, 28 and 56</description>
    <arm_group_label>placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>AllerT low dose</intervention_name>
    <description>SC injections of AllerT 25-50 micrograms on days 1, 7, 14, 28 and 56</description>
    <arm_group_label>AllerT low dose</arm_group_label>
    <other_name>AllerT 25-50 micrograms</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>AllerT full dose</intervention_name>
    <description>SC injections of AllerT 50-100 micrograms on days 1, 7, 14, 28 and 56</description>
    <arm_group_label>AllerT full dose</arm_group_label>
    <other_name>AllerT 50-100 micrograms</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  moderate to severe allergic rhinoconjunctivitis to birch pollen:&#xD;
&#xD;
               1. Score of symptoms of the Rhinoconjunctivitis Symptom Score (RSS) ≥ 12 during the&#xD;
                  two preceding birch pollen seasons&#xD;
&#xD;
               2. Previous use of anti-allergy medications during the two preceding birch pollen&#xD;
                  seasons&#xD;
&#xD;
               3. Positive SPT to birch pollen extract&#xD;
&#xD;
               4. Positive specific IgE CAP test for Bet v 1&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  uncontrolled asthma, FEV1 &lt; 80% of predicted&#xD;
&#xD;
          -  previous SIT (specific immunotherapy) to birch pollen or any other SIT within 5 years&#xD;
&#xD;
          -  clinical symptoms due to allergens other than birch pollen during the whole trial&#xD;
             period&#xD;
&#xD;
          -  history of anaphylaxis&#xD;
&#xD;
          -  positive skin prick test to AllerT&#xD;
&#xD;
          -  any other treatment or conditions which may increase the risk of the study for the&#xD;
             subject or affect the efficacy assessments during the birch pollen season&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Francois Spertini, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Centre Hospitalier Universitaire Vaudois</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Allergiklinikken</name>
      <address>
        <city>Hellerup</city>
        <state>Copenhagen</state>
        <zip>2900</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lungemedicinsk Forskningsafdeling</name>
      <address>
        <city>Arhus</city>
        <zip>8000</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinisk Institute</name>
      <address>
        <city>Odense</city>
        <zip>5000</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Reims</name>
      <address>
        <city>Reims</city>
        <zip>51092</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopitaux Universitaires de Strasbourg</name>
      <address>
        <city>Strasbourg</city>
        <zip>67000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Viktorija Vevere private practice of Allergology</name>
      <address>
        <city>Rezekne</city>
        <zip>4601</zip>
        <country>Latvia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Paul Stradins Clinical University Hospital - Pulmonology Allergology</name>
      <address>
        <city>Riga</city>
        <zip>1002</zip>
        <country>Latvia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Center of examination and treatment of allergic diseases</name>
      <address>
        <city>Riga</city>
        <zip>1003</zip>
        <country>Latvia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kaunas Clinics University Hospital</name>
      <address>
        <city>Kaunas</city>
        <zip>50009</zip>
        <country>Lithuania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Allergy Clinic JSC Perspektyvos</name>
      <address>
        <city>Vilnius</city>
        <zip>08431</zip>
        <country>Lithuania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vilnius University Hospital</name>
      <address>
        <city>Vilnius</city>
        <zip>08661</zip>
        <country>Lithuania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Antakalnio affiliation of the Vilnius City Allergy Center</name>
      <address>
        <city>Vilnius</city>
        <zip>10200</zip>
        <country>Lithuania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SPZOZ Uniwersytecki Szpital Kliniczny - Allergology</name>
      <address>
        <city>Lodz</city>
        <zip>90153</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alergologii Centrum</name>
      <address>
        <city>Lodz</city>
        <zip>90553</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alergotest</name>
      <address>
        <city>Lublin</city>
        <zip>20095</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alergo-Med</name>
      <address>
        <city>Tarnow</city>
        <zip>33100</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centrum Alergologii IRMED</name>
      <address>
        <city>Warszawa</city>
        <zip>01157</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Silesian Piasts University of Medicine in Wrocław</name>
      <address>
        <city>Wroclaw</city>
        <zip>50-368</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aler-med</name>
      <address>
        <city>Wroclaw</city>
        <zip>54203</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NZOZ Przychodnia Lekarska Hipokrates</name>
      <address>
        <city>Zabrze</city>
        <zip>41800</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University hospital Skane</name>
      <address>
        <city>Lund</city>
        <zip>22185</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Orebro University Hospital</name>
      <address>
        <city>Orebro</city>
        <zip>70185</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lungavdelningen, Vastmanlands</name>
      <address>
        <city>Vasteras</city>
        <zip>72189</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire Vaudois</name>
      <address>
        <city>Lausanne</city>
        <state>VD</state>
        <zip>1005</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
    <country>France</country>
    <country>Latvia</country>
    <country>Lithuania</country>
    <country>Poland</country>
    <country>Sweden</country>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>March 2015</verification_date>
  <study_first_submitted>October 29, 2012</study_first_submitted>
  <study_first_submitted_qc>October 31, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 2, 2012</study_first_posted>
  <results_first_submitted>March 20, 2015</results_first_submitted>
  <results_first_submitted_qc>March 30, 2015</results_first_submitted_qc>
  <results_first_posted type="Estimate">April 13, 2015</results_first_posted>
  <last_update_submitted>March 30, 2015</last_update_submitted>
  <last_update_submitted_qc>March 30, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 13, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>allergic rhinitis</keyword>
  <keyword>birch pollen</keyword>
  <keyword>immunotherapy</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>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Placebo</title>
          <description>SC injections of placebo&#xD;
placebo: SC injections of placebo on days 1, 7, 14, 28 and 56</description>
        </group>
        <group group_id="P2">
          <title>AllerT Low Dose</title>
          <description>SC injections of AllerT 25 or 50 micrograms&#xD;
AllerT low dose: SC injections of AllerT 25-50 micrograms on days 1, 7, 14, 28 and 56</description>
        </group>
        <group group_id="P3">
          <title>AllerT Full Dose</title>
          <description>SC injections of AllerT 50-100 micrograms&#xD;
AllerT full dose: SC injections of AllerT 50-100 micrograms on days 1, 7, 14, 28 and 56</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="79"/>
                <participants group_id="P2" count="79"/>
                <participants group_id="P3" count="82"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="78"/>
                <participants group_id="P2" count="77"/>
                <participants group_id="P3" count="82"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>In AllerT low dose group, one patient has been randomized but not treated explaining the difference beween baseline participants number and participant flow</population>
      <group_list>
        <group group_id="B1">
          <title>Placebo</title>
          <description>SC injections of placebo&#xD;
placebo: SC injections of placebo on days 1, 7, 14, 28 and 56</description>
        </group>
        <group group_id="B2">
          <title>AllerT Low Dose</title>
          <description>SC injections of AllerT 25 or 50 micrograms&#xD;
AllerT low dose: SC injections of AllerT 25-50 micrograms on days 1, 7, 14, 28 and 56</description>
        </group>
        <group group_id="B3">
          <title>AllerT Full Dose</title>
          <description>SC injections of AllerT 50-100 micrograms&#xD;
AllerT full dose: SC injections of AllerT 50-100 micrograms on days 1, 7, 14, 28 and 56</description>
        </group>
        <group group_id="B4">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="79"/>
            <count group_id="B2" value="78"/>
            <count group_id="B3" value="82"/>
            <count group_id="B4" value="239"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="34.1" spread="9.08"/>
                    <measurement group_id="B2" value="36.2" spread="9.92"/>
                    <measurement group_id="B3" value="36.4" spread="9.36"/>
                    <measurement group_id="B4" value="35.6" spread="9.45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="38"/>
                    <measurement group_id="B2" value="43"/>
                    <measurement group_id="B3" value="43"/>
                    <measurement group_id="B4" value="124"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="41"/>
                    <measurement group_id="B2" value="35"/>
                    <measurement group_id="B3" value="39"/>
                    <measurement group_id="B4" value="115"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Combined Rhinoconjunctivitis Symptom and Medication Score</title>
        <description>The efficacy analysis will be performed on the symptom and medication data collected from the first day of the birch pollen season as defined by pollen counts in the air in each site region (from March to May 2013 depending on site region), to 42 days later or to the end of the pollen season, whichever comes first.&#xD;
The scale range is from 0 to 3. Lower is the the RSMS value, better is the efficacy as this implies that lower is the symptoms and concomitant medication intake by the patient The RSMS includes 2 subscales : the Rhinoconjunctivitis Symptom Score (RSS) with a range of values from 0 to 3 and the Rhinoconjunctivitis Medication Score Score (RMS) with also a range of values from 0 to 3 The RSMS is the sum of the RSS and RMS divided by 2</description>
        <time_frame>up to 6 weeks during the birch pollen season 2013</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>SC injections of placebo&#xD;
placebo: SC injections of placebo on days 1, 7, 14, 28 and 56</description>
          </group>
          <group group_id="O2">
            <title>AllerT Low Dose</title>
            <description>SC injections of AllerT 25 or 50 micrograms&#xD;
AllerT low dose: SC injections of AllerT 25-50 micrograms on days 1, 7, 14, 28 and 56</description>
          </group>
          <group group_id="O3">
            <title>AllerT Full Dose</title>
            <description>SC injections of AllerT 50-100 micrograms&#xD;
AllerT full dose: SC injections of AllerT 50-100 micrograms on days 1, 7, 14, 28 and 56</description>
          </group>
        </group_list>
        <measure>
          <title>Combined Rhinoconjunctivitis Symptom and Medication Score</title>
          <description>The efficacy analysis will be performed on the symptom and medication data collected from the first day of the birch pollen season as defined by pollen counts in the air in each site region (from March to May 2013 depending on site region), to 42 days later or to the end of the pollen season, whichever comes first.&#xD;
The scale range is from 0 to 3. Lower is the the RSMS value, better is the efficacy as this implies that lower is the symptoms and concomitant medication intake by the patient The RSMS includes 2 subscales : the Rhinoconjunctivitis Symptom Score (RSS) with a range of values from 0 to 3 and the Rhinoconjunctivitis Medication Score Score (RMS) with also a range of values from 0 to 3 The RSMS is the sum of the RSS and RMS divided by 2</description>
          <units>score (maximum=3)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="78"/>
                <count group_id="O2" value="77"/>
                <count group_id="O3" value="82"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.86" spread="0.603"/>
                    <measurement group_id="O2" value="0.64" spread="0.530"/>
                    <measurement group_id="O3" value="0.72" spread="0.573"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Quality of Life</title>
        <description>mini-RQLQ questionnaires</description>
        <time_frame>up to 6 weeks during the birch pollen season 2013</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Safety and Tolerability</title>
        <description>Adverse events will be collected throughout the trial period and will be reported as Treatment emergent adverse events occurring between start of treatment and 28 days after completion of treatment for each subject</description>
        <time_frame>from start of treatment to 28 days after completion of treatment, i.e. for approximately 12 weeks</time_frame>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Immunological Markers: Specific IgE and IgG4</title>
        <description>blood samples will be drawn at the above time points to measure immunological markers: specific IgE and IgG4</description>
        <time_frame>before treatment, 4 weeks after the last injection and 2 weeks before, at the peak time and within 2 weeks after the end of the expected birch pollen season 2013</time_frame>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Placebo</title>
          <description>All patients having received at least one injection of Placebo (Safety Set)</description>
        </group>
        <group group_id="E2">
          <title>Allert 50 µg</title>
          <description>All patients having received at least one injection of Allert 50 µg (Safety Set)</description>
        </group>
        <group group_id="E3">
          <title>AllerT 100 µg</title>
          <description>All patients having received at least one injection of Allert 100 µg (Safety Set)</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>conjunctivitis</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="82"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>conjunctivitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="82"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title vocab="Oropharyngeal discom">Oropharyngeal discomfort</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="82"/>
              </event>
              <event>
                <sub_title vocab="Tongue oedema">Tongue oedema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="82"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title vocab="Hypersensitivity">Hypersensitivity</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="82"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title vocab="Skull fracture">Skull fracture</sub_title>
                <description>considered as non drug-related</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="82"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title vocab="Urticaria">Urticaria</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="82"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>Injection site pain</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="59" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="70" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="70" subjects_at_risk="82"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title vocab="Conjunctivitis">Conjunctivitis</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="12" subjects_at_risk="82"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title vocab="Nasopharyngitis">Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="14" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="16" subjects_at_risk="82"/>
              </event>
              <event>
                <sub_title vocab="Rhinitis">Rhinitis</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="22" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="25" subjects_at_risk="82"/>
              </event>
              <event>
                <sub_title vocab="Dyspnea">Dyspnea</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="17" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="25" subjects_at_risk="82"/>
              </event>
              <event>
                <sub_title vocab="Cough">Cough</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="12" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="26" subjects_at_risk="82"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Injection site pain</sub_title>
                <counts group_id="E1" subjects_affected="26" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="20" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="16" subjects_at_risk="82"/>
              </event>
              <event>
                <sub_title vocab="Injection site react">Injection site reaction</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="19" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="15" subjects_at_risk="82"/>
              </event>
              <event>
                <sub_title vocab="Injection site eryth">Injection site erythema</sub_title>
                <counts group_id="E1" subjects_affected="18" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="11" subjects_at_risk="82"/>
              </event>
              <event>
                <sub_title vocab="Pruritus">Pruritus</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="20" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="11" subjects_at_risk="82"/>
              </event>
              <event>
                <sub_title vocab="Injection site oedem">Injection site oedema</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="13" subjects_at_risk="82"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The PI of the trial owns options in the sponsor company and is member of the Board of Anergis SA</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr Gilles DELLA CORTE Clinical Development Director</name_or_title>
      <organization>ANERGIS SA</organization>
      <phone>+41 21 651 92 30</phone>
      <email>gilles.dellacorte@anergis.ch</email>
    </point_of_contact>
  </clinical_results>
</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/NCT01720251
org study id: AN004T
secondary id: 2011-002259-32
nct id: NCT01720251
lead sponsor: 
has dmc: No
The main objective of the trial is to demonstrate the efficacy of a two months pre-seasonal
      treatment with AllerT 100 µg maintenance dose in reducing symptoms of allergic
      rhinoconjunctivitis during the following birch pollen season
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Combined Rhinoconjunctivitis Symptom and Medication Score
time frame: up to 6 weeks during the birch pollen season 2013
description: The efficacy analysis will be performed on the symptom and medication data collected from the first day of the birch pollen season as defined by pollen counts in the air in each site region (from March to May 2013 depending on site region), to 42 days later or to the end of the pollen season, whichever comes first.
The scale range is from 0 to 3. Lower is the the RSMS value, better is the efficacy as this implies that lower is the symptoms and concomitant medication intake by the patient The RSMS includes 2 subscales : the Rhinoconjunctivitis Symptom Score (RSS) with a range of values from 0 to 3 and the Rhinoconjunctivitis Medication Score Score (RMS) with also a range of values from 0 to 3 The RSMS is the sum of the RSS and RMS divided by 2
measure: Quality of Life
time frame: up to 6 weeks during the birch pollen season 2013
description: mini-RQLQ questionnaires
measure: Safety and Tolerability
time frame: from start of treatment to 28 days after completion of treatment, i.e. for approximately 12 weeks
description: Adverse events will be collected throughout the trial period and will be reported as Treatment emergent adverse events occurring between start of treatment and 28 days after completion of treatment for each subject
measure: Immunological Markers: Specific IgE and IgG4
time frame: before treatment, 4 weeks after the last injection and 2 weeks before, at the peak time and within 2 weeks after the end of the expected birch pollen season 2013
description: blood samples will be drawn at the above time points to measure immunological markers: specific IgE and IgG4
arm group label: placebo
arm group type: Placebo Comparator
description: SC injections of placebo
arm group label: AllerT low dose
arm group type: Experimental
description: SC injections of AllerT 25 or 50 micrograms
arm group label: AllerT full dose
arm group type: Experimental
description: SC injections of AllerT 50-100 micrograms
intervention type: Drug
intervention name: placebo
description: SC injections of placebo on days 1, 7, 14, 28 and 56
arm group label: placebo
intervention type: Drug
intervention name: AllerT low dose
description: SC injections of AllerT 25-50 micrograms on days 1, 7, 14, 28 and 56
arm group label: AllerT low dose
other name: AllerT 25-50 micrograms
intervention type: Drug
intervention name: AllerT full dose
description: SC injections of AllerT 50-100 micrograms on days 1, 7, 14, 28 and 56
arm group label: AllerT full dose
other name: AllerT 50-100 micrograms
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: No
last name: Francois Spertini, MD
role: Principal Investigator
affiliation: Centre Hospitalier Universitaire Vaudois
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country: Denmark
country: France
country: Latvia
country: Lithuania
country: Poland
country: Sweden
country: Switzerland
responsible party type: Sponsor
mesh term: Rhinitis
mesh term: Rhinitis, Allergic
participant flow: 
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outcome list: 
reported events: 
certain agreements: 
point of contact: 