<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/NCT01728519</url>
  </required_header>
  <id_info>
    <org_study_id>AN003</org_study_id>
    <nct_id>NCT01728519</nct_id>
  </id_info>
  <brief_title>Phase I/IIa Clinical Evaluation of AllerT vs Placebo in Subjects Allergic to Birch Pollen</brief_title>
  <acronym>AN003</acronym>
  <official_title>Phase I/IIa Study to Assess the Safety, Immunogenicity and Efficacy of AllerT, a Combination of Peptides Derived From Bet v 1, Administered Via the Subcutaneous or Intradermal Route to Volunteers 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>
      Birch pollen allergic patients are currently treated by subcutaneous injections of pollen&#xD;
      extracts either by standard allergen specific immunotherapy (SIT) or ultra-rush&#xD;
      immunotherapy. Such treatment is prone to side effects and has to be performed in a hospital&#xD;
      environment due to the risk of potential anaphylactic reactions. The aim of this study is to&#xD;
      test the new product AllerT expected to show widely reduced side effects. AllerT will be&#xD;
      injected via two different routes, subcutaneous versus intradermal. The primary endpoint of&#xD;
      the study is the local and systemic safety of repeated injections of the product. Since&#xD;
      AllerT should provide patients with a pre-seasonal treatment to decrease seasonal allergic&#xD;
      symptoms, we will also evaluate the potential efficacy of the approach using a nasal&#xD;
      provocation test (NPT) with birch pollen&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In addition to the initial protocol, post hoc evaluations were conducted, after new ethics&#xD;
      committee reviews, to assess quality of life during the birch pollen season following the&#xD;
      trial (April 2009) and to obtain blood samples for evaluation of immunology markers IgG4 and&#xD;
      IgE after the season 2010 (July 2010) and after the season 2012 (July 2012),&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Recruitment was stopped before start of the pollen season&#xD;
  </why_stopped>
  <start_date>August 2008</start_date>
  <completion_date type="Actual">July 2012</completion_date>
  <primary_completion_date type="Actual">March 2009</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>Factorial Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of participants with adverse events</measure>
    <time_frame>84 days</time_frame>
    <description>collection of local or systemic allergic reactions and any other adverse events through patient diaries and investigators' interviews during the 8-week treatment period and 4 week post-treatment follow-up (Day 84)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>change from baseline in blood levels of specific IgG4 and IgE</measure>
    <time_frame>after 7, 14, 21, 56 and 84 days and after 16 to 18 months and 40 to 42 months</time_frame>
    <description>blood samples were taken at baseline and at weeks 1, 2, 4 and 8 of the treatment period, 4 weeks later and then in July 2010 and in July 2012</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change from baseline in nasal provocation tests</measure>
    <time_frame>84 days</time_frame>
    <description>nasal provocation tests with birch pollen extract are assessed before treatment and at visit on day 84 of the trial, 4 weeks after completion of treatment</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Total score of the Mini-RQLQ Quality-of-life questionnaire</measure>
    <time_frame>4 weeks during April 2009</time_frame>
    <description>weekly questionnaires are filled in by the subjects during April 2009 at the time of the birch pollen season in the trial center area</description>
  </other_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">29</enrollment>
  <condition>Allergic Rhinitis</condition>
  <condition>Allergy</condition>
  <arm_group>
    <arm_group_label>AllerT SC</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>AllerT subcutaneous injections</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo SC</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>placebo subcutaneous injections</description>
  </arm_group>
  <arm_group>
    <arm_group_label>AllerT ID</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>AllerT intra-dermal injections</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo ID</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>placebo intra-dermal injections</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>AllerT SC</intervention_name>
    <description>AllerT subcutaneous injections on days 1, 7, 14, 21 and 56 - cumulative dose 440 microgram)</description>
    <arm_group_label>AllerT SC</arm_group_label>
    <other_name>AllerT subcutaneous injections</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>AllerT ID</intervention_name>
    <description>AllerT intra-dermal injections on days 1, 7, 14, 21 and 56 - cumulative dose 440 microgram)</description>
    <arm_group_label>AllerT ID</arm_group_label>
    <other_name>Aller T intra-dermal injections</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo SC</intervention_name>
    <description>Placebo subcutaneous injections on days 1, 7, 14, 21 and 56</description>
    <arm_group_label>Placebo SC</arm_group_label>
    <other_name>Placebo subcutaneous injections</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo ID</intervention_name>
    <description>Placebo intra-dermal injections on days 1, 7, 14, 21 and 56</description>
    <arm_group_label>Placebo ID</arm_group_label>
    <other_name>Placebo intra-dermal</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Allergic rhinitis symptoms during the pollen season preceding the study, confirmed by&#xD;
             SPT (prick tests) and/or a positive specific IgE CAP test for birch pollen (class I&#xD;
             minimum)&#xD;
&#xD;
          -  Positive SPT to Bet v 1 (prick tests), negative SPT to AllerT&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  received immunotherapy against any allergen within 3 years before the start of the&#xD;
             study.&#xD;
&#xD;
          -  symptomatic to perennial allergens or active seasonal allergy during the trial.&#xD;
&#xD;
          -  non controlled asthma (peak flow lower than 30% of predicted value).&#xD;
&#xD;
          -  history of any severe medical condition able to influence the course of the study&#xD;
&#xD;
          -  Any confirmed or suspected immunodeficiency condition, including human&#xD;
             immunodeficiency virus (HIV) infection and asplenia.&#xD;
&#xD;
          -  Subjects under immunosuppressive medication.&#xD;
&#xD;
          -  Pregnant or lactating women or women willing or intending to become pregnant during&#xD;
             the study.&#xD;
&#xD;
          -  Any other significant finding which, in the opinion of the investigator, would&#xD;
             increase the risk of having an adverse outcome from participating in this protocol or&#xD;
             of dropping out of the study&#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>University of Lausanne Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Lausanne University Hospital</name>
      <address>
        <city>Lausanne</city>
        <zip>1005</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>November 2012</verification_date>
  <study_first_submitted>November 9, 2012</study_first_submitted>
  <study_first_submitted_qc>November 13, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 20, 2012</study_first_posted>
  <last_update_submitted>November 13, 2012</last_update_submitted>
  <last_update_submitted_qc>November 13, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 20, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Allergy</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>
  <!-- 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/NCT01728519
org study id: AN003
nct id: NCT01728519
lead sponsor: 
has dmc: No
Birch pollen allergic patients are currently treated by subcutaneous injections of pollen
      extracts either by standard allergen specific immunotherapy (SIT) or ultra-rush
      immunotherapy. Such treatment is prone to side effects and has to be performed in a hospital
      environment due to the risk of potential anaphylactic reactions. The aim of this study is to
      test the new product AllerT expected to show widely reduced side effects. AllerT will be
      injected via two different routes, subcutaneous versus intradermal. The primary endpoint of
      the study is the local and systemic safety of repeated injections of the product. Since
      AllerT should provide patients with a pre-seasonal treatment to decrease seasonal allergic
      symptoms, we will also evaluate the potential efficacy of the approach using a nasal
      provocation test (NPT) with birch pollen
In addition to the initial protocol, post hoc evaluations were conducted, after new ethics
      committee reviews, to assess quality of life during the birch pollen season following the
      trial (April 2009) and to obtain blood samples for evaluation of immunology markers IgG4 and
      IgE after the season 2010 (July 2010) and after the season 2012 (July 2012),
allocation: Randomized
intervention model: Factorial Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Number of participants with adverse events
time frame: 84 days
description: collection of local or systemic allergic reactions and any other adverse events through patient diaries and investigators' interviews during the 8-week treatment period and 4 week post-treatment follow-up (Day 84)
measure: change from baseline in blood levels of specific IgG4 and IgE
time frame: after 7, 14, 21, 56 and 84 days and after 16 to 18 months and 40 to 42 months
description: blood samples were taken at baseline and at weeks 1, 2, 4 and 8 of the treatment period, 4 weeks later and then in July 2010 and in July 2012
measure: change from baseline in nasal provocation tests
time frame: 84 days
description: nasal provocation tests with birch pollen extract are assessed before treatment and at visit on day 84 of the trial, 4 weeks after completion of treatment
measure: Total score of the Mini-RQLQ Quality-of-life questionnaire
time frame: 4 weeks during April 2009
description: weekly questionnaires are filled in by the subjects during April 2009 at the time of the birch pollen season in the trial center area
arm group label: AllerT SC
arm group type: Experimental
description: AllerT subcutaneous injections
arm group label: Placebo SC
arm group type: Placebo Comparator
description: placebo subcutaneous injections
arm group label: AllerT ID
arm group type: Experimental
description: AllerT intra-dermal injections
arm group label: Placebo ID
arm group type: Placebo Comparator
description: placebo intra-dermal injections
intervention type: Drug
intervention name: AllerT SC
description: AllerT subcutaneous injections on days 1, 7, 14, 21 and 56 - cumulative dose 440 microgram)
arm group label: AllerT SC
other name: AllerT subcutaneous injections
intervention type: Drug
intervention name: AllerT ID
description: AllerT intra-dermal injections on days 1, 7, 14, 21 and 56 - cumulative dose 440 microgram)
arm group label: AllerT ID
other name: Aller T intra-dermal injections
intervention type: Drug
intervention name: Placebo SC
description: Placebo subcutaneous injections on days 1, 7, 14, 21 and 56
arm group label: Placebo SC
other name: Placebo subcutaneous injections
intervention type: Drug
intervention name: Placebo ID
description: Placebo intra-dermal injections on days 1, 7, 14, 21 and 56
arm group label: Placebo ID
other name: Placebo intra-dermal
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: No
last name: Francois Spertini, MD
role: Principal Investigator
affiliation: University of Lausanne Hospital
facility: 
country: Switzerland
responsible party type: Sponsor
mesh term: Rhinitis
mesh term: Rhinitis, Allergic