<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/NCT03776643</url>
  </required_header>
  <id_info>
    <org_study_id>P 160936J</org_study_id>
    <nct_id>NCT03776643</nct_id>
  </id_info>
  <brief_title>Safety and Efficacy of Low-dose IL-2 in Birch Pollen Allergy</brief_title>
  <acronym>Rhinil-2</acronym>
  <official_title>Safety and Efficacy of Low-dose IL-2 in Birch Pollen Allergy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assistance Publique - Hôpitaux de Paris</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Iltoo Pharma</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Assistance Publique - Hôpitaux de Paris</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Several studies have reported a deficit and/or a defect in regulatory T cells in allergic&#xD;
      subjects, which can be correlated with the allergic responses, especially for respiratory&#xD;
      allergies. Low-dose IL-2 (ld-IL2) specifically targets and activates regulatory T cells&#xD;
      (Tregs), which are cells that regulate immune responses. Thus by stimulating Tregs, ld-IL2&#xD;
      would control allergic responses.&#xD;
&#xD;
      This study is designed to evaluate the efficacy of ILT-101 (ld-IL-2), compared to placebo, on&#xD;
      the nasal response assessed by Total Nasal Symptom Score (TNSS) during a controlled birch&#xD;
      allergen exposure.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Primary objective To evaluate the efficacy of ILT-101 (ld-IL-2), compared to placebo, on&#xD;
      nasal response on day 40&#xD;
&#xD;
      Secondary objectives To evaluate the efficacy of ILT-101 on rhino-conjunctivitis symptoms, on&#xD;
      inflammatory mediators, allergic specific immune responses and safety.&#xD;
&#xD;
      Experimental design This is a monocentric, randomized, placebo controlled, double-blind trial&#xD;
      in parallel-groups, evaluating a treatment by ILT-101/placebo, 1 MIU daily for 5 days and 1&#xD;
      MIU every week, until day 36.&#xD;
&#xD;
      Population involved Male or female, aged between 18 and 55 years, with allergic rhinitis to&#xD;
      birch pollen.&#xD;
&#xD;
      Number of subjects: 24&#xD;
&#xD;
      Duration of patient participation: 3 months (treatment period: 36 days months, follow-up&#xD;
      period: 34 days)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2019</start_date>
  <completion_date type="Actual">August 16, 2022</completion_date>
  <primary_completion_date type="Actual">August 16, 2022</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>
    <intervention_model_description>Safety/Efficacy</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
    <masking_description>Double Blind</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change in nasal congestion expressed as area under the curve (AUC), during birch allergen exposure in ALYATEC's Environmental Exposure Chamber (EEC)</measure>
    <time_frame>on day 40</time_frame>
    <description>Change in nasal congestion expressed as area under the curve (AUC), during birch allergen exposure in ALYATEC's Environmental Exposure Chamber (EEC)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in nasal congestion expressed as area under the curve (AUC), assessed during 4 hours of exposure</measure>
    <time_frame>at Day 8</time_frame>
    <description>TNSS, expressed as area under the curve (AUC), assessed during 4 hours of exposure: TOTAL NASAL SYMPTOM SCORE Definition of response choices (drop down menu for each of the 4 questions below) 0 = None 1 = Mild (symptom clearly present but easily tolerated) 2 = Moderate (annoying but tolerable symptom) 3 = Severe (difficult to tolerate symptom, disrupts activities)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in nasal response intensity</measure>
    <time_frame>at Day 8</time_frame>
    <description>determined by Visual Analogue Scale (VAS) ranged from 0 to 10 cm where higher values correspond to more intense symptoms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Tregs expressed in percentag (%)</measure>
    <time_frame>at day 8</time_frame>
    <description>Changes in Tregs in percentag compared to baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Tregs expressed in percentag (%)</measure>
    <time_frame>at day 40</time_frame>
    <description>Changes in Tregs in percentag compared to baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Tregs expressed in percentag (%)</measure>
    <time_frame>at day 70</time_frame>
    <description>Changes in Tregs in percentag compared to baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in absolute count in Tregs</measure>
    <time_frame>at day 8</time_frame>
    <description>Changes in absolute count in Tregs compared to baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in absolute count in Tregs</measure>
    <time_frame>at day 40</time_frame>
    <description>Changes in absolute count in Tregs compared to baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in absolute count in Tregs</measure>
    <time_frame>at day 70</time_frame>
    <description>Changes in absolute count in Tregs compared to baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in eosinophils expressed in percentag (%)</measure>
    <time_frame>at day 8</time_frame>
    <description>Changes in eosinophils in percentag compared to baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in eosinophils expressed in percentag (%)</measure>
    <time_frame>at day 40</time_frame>
    <description>Changes in eosinophils in percentag compared to baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in eosinophils expressed in percentag (%)</measure>
    <time_frame>at day 70</time_frame>
    <description>Changes in eosinophils in percentag compared to baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in absolute count in eosinophils</measure>
    <time_frame>at day 8</time_frame>
    <description>Changes in absolute count in eosinophils compared to baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in absolute count in eosinophils</measure>
    <time_frame>at day 40</time_frame>
    <description>Changes in absolute count in eosinophils compared to baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in absolute count in eosinophils</measure>
    <time_frame>at day 70</time_frame>
    <description>Changes in absolute count in eosinophils compared to baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Inate Lymphoid Cell type 2(ILC2) expressed in percentag (%)</measure>
    <time_frame>at day 8</time_frame>
    <description>Changes in Inate Lymphoid Cell type 2 in percentag compared to baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Inate Lymphoid Cell type 2(ILC2) expressed in percentag (%)</measure>
    <time_frame>at day 40</time_frame>
    <description>Changes in Inate Lymphoid Cell type 2 in percentag compared to baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Inate Lymphoid Cell type 2(ILC2) expressed in percentag (%)</measure>
    <time_frame>at day 70</time_frame>
    <description>Changes in Inate Lymphoid Cell type 2 in percentag compared to baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in absolute count in Inate Lymphoid Cell type 2(ILC2)</measure>
    <time_frame>at day 8</time_frame>
    <description>Changes (in absolute count in Inate Lymphoid Cell type 2 compared to baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in absolute count in Inate Lymphoid Cell type 2(ILC2)</measure>
    <time_frame>at day 40</time_frame>
    <description>Changes (in absolute count in Inate Lymphoid Cell type 2 compared to baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in absolute count in Inate Lymphoid Cell type 2(ILC2)</measure>
    <time_frame>at day 70</time_frame>
    <description>Changes (in absolute count in Inate Lymphoid Cell type 2 compared to baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes of antigen-specific T-cell immune responses (cytokine IL-4 )</measure>
    <time_frame>at day 40</time_frame>
    <description>cytokine IL-4 at day 40</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes of antigen-specific T-cell immune responses (cytokine IL-4 )</measure>
    <time_frame>at day 70</time_frame>
    <description>cytokine IL-4 at day 70</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes of antigen-specific T-cell immune responses (cytokine IL-5)</measure>
    <time_frame>at day 40</time_frame>
    <description>cytokine IL-5 at day 40</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes of antigen-specific T-cell immune responses (cytokine IL-5)</measure>
    <time_frame>at day 70</time_frame>
    <description>cytokine IL-5 at day 70</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes of antigen-specific T-cell immune responses</measure>
    <time_frame>at day 40</time_frame>
    <description>IL-13 secretion after antigen restimulation at day 40</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes of antigen-specific T-cell immune responses</measure>
    <time_frame>at day 70</time_frame>
    <description>IL-13 secretion after antigen restimulation at day 70</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in allergen-specific IgE dosages basophil activation test with pollen allergen</measure>
    <time_frame>at day 40</time_frame>
    <description>allergen-specific IgE dosages at day 40</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of adverse events at day 8</measure>
    <time_frame>up to Day 8</time_frame>
    <description>Adverse events throughout the study (according to NCI-CTC AE classification)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of adverse events at day 40</measure>
    <time_frame>up to Day 40</time_frame>
    <description>Adverse events throughout the study (according to NCI-CTC AE classification)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of adverse events at 70</measure>
    <time_frame>up to Day 70</time_frame>
    <description>Adverse events throughout the study (according to NCI-CTC AE classification)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Allergic Rhinoconjunctivitis to Birch Pollen</condition>
  <condition>With a Positive Skin Prick Test to Birch Pollen</condition>
  <arm_group>
    <arm_group_label>ILT-101 (ld-IL2)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subcutaneous injections of ILT-101</description>
  </arm_group>
  <arm_group>
    <arm_group_label>placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Subcutaneous injections of placebo</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ILT-101 ld-(IL2)</intervention_name>
    <description>Subcutaneous injections of ILT-101 or Placebo starting with once-daily administration for 5 consecutive days followed by once every two weeks administration during five months</description>
    <arm_group_label>ILT-101 (ld-IL2)</arm_group_label>
    <arm_group_label>placebo</arm_group_label>
    <other_name>Placebo</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria&#xD;
&#xD;
          -  male or female aged between18-55 years&#xD;
&#xD;
          -  Positive clinical history of seasonal allergic rhinitis to birch pollen for at least 2&#xD;
             consecutive pollinic seasons before inclusion and requiring medication intake with or&#xD;
             without GINA 1 associated asthma, with documentation of sensitivity within 12 months&#xD;
             before enrollment by : *Positive skin prick test (SPT) and validated in vitro tests&#xD;
             for specific Immunoglobulin E (IgE); *Positive Skin prick test (SPT): wheal for birch&#xD;
             pollen ≥ 5 mm in diameter for histamine wheal ≥ 3 mm (positive control) and NaCl&#xD;
             reaction &lt; 2 mm (negative control) *Positive specific IgE to birch pollen &gt;0.75 kUI/L;&#xD;
&#xD;
          -  Negative beta-HcG pregnancy test at screening visit for women of childbearing age;&#xD;
&#xD;
          -  Normal electrocardiogram without clinically significant abnormalities;&#xD;
&#xD;
          -  Ability to stay in the EEC for up to 4 hours, without any conditions or factors which&#xD;
             could make this not possible&#xD;
&#xD;
          -  Positive nasal response (TNSS≥5) at baseline exposure&#xD;
&#xD;
          -  Free, informed and written consent signed by the patient and the investigator, before&#xD;
             any specific examination required by the study;&#xD;
&#xD;
          -  Affiliation to a social security scheme (beneficiary or assignee)&#xD;
&#xD;
          -  Negative SARS-CoV-2 test less than 72 hours prior to screening visit&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Asthma: GINA 2 to 5&#xD;
&#xD;
          -  Eosinophilia &gt; 0.6x109/mL;&#xD;
&#xD;
          -  Any history of anaphylactic reactions;&#xD;
&#xD;
          -  Specific immunotherapy treatment at the moment, including Omalizumab;&#xD;
&#xD;
          -  Specific immunotherapy for birch-pollens within 3 previous years;&#xD;
&#xD;
          -  Use of systemic corticosteroid or others immunosuppressive treatment within previous 6&#xD;
             months;&#xD;
&#xD;
          -  Moderate to severe allergic rhinoconjunctivitis with or without asthma due to grass&#xD;
             pollen, if the study is performed during grass pollen season (according to ARIA)&#xD;
&#xD;
          -  Significant rhinitis, or sinusitis, due to daily contact with other allergen causing&#xD;
             symptoms that are expected to coincide with exposures, as assessed by the investigator&#xD;
&#xD;
          -  Contraindications known to treatment with IL-2:&#xD;
&#xD;
               -  Hypersensitivity to the active substance or to any of the excipients;&#xD;
&#xD;
               -  Immunosuppressed patient;&#xD;
&#xD;
               -  Psychotropic, hepatotoxic, nephrotoxic, myelotoxic or cardiotoxic drugs;&#xD;
&#xD;
               -  Other chronic diseases not clinically controlled;&#xD;
&#xD;
               -  Signs of active infection requiring treatment;&#xD;
&#xD;
               -  Previous history of organ transplantation.&#xD;
&#xD;
               -  Heart failure (≥ grade II, class. NYHA), kidney failure (Cockroft &lt;60&#xD;
                  ml/min/1.73m2), liver failure (transaminase&gt; 3N), pulmonary insufficiency (any&#xD;
                  grade);&#xD;
&#xD;
          -  Leukocytes &lt;3000 / mm3 lymphocytes &lt;800 / mm3, platelets &lt;80 000 / mm3, Hemoglobin &lt;&#xD;
             10.0 g/dL or 6.2 mmol/L, red cell blood &lt; 3.5 T/L;&#xD;
&#xD;
          -  Positivity of at least one of the thyroid-specific antibodies (anti-TPO, anti-TG, or&#xD;
             anti-TRAKS) associated with an abnormal thyroid workup (TSH, T3, or T4) at inclusion;&#xD;
&#xD;
          -  Chronic uncontrolled arterial hypertension (Systolic BP &gt; 140 mmHg and/or Diastolic BP&#xD;
             &gt; 90 mmHg);&#xD;
&#xD;
          -  Poor venous capital will forbid blood samples;&#xD;
&#xD;
          -  Vaccination with attenuated live vaccine in the month before the inclusion or planned&#xD;
             during the study;&#xD;
&#xD;
          -  Vaccination against COVID-19 during the study period or if the 2nd dose of vaccine is&#xD;
             planned during the 15 days preceding Visit 3&#xD;
&#xD;
          -  Surgery in the previous three months or anticipated under study;&#xD;
&#xD;
          -  Participation in other interventional research with study drug in the previous month&#xD;
             and during the study;&#xD;
&#xD;
          -  Psychiatric illness or any other concomitant chronic illness or addiction that could&#xD;
             interfere with the ability to meet the requirements of the protocol or provide&#xD;
             informed consent;&#xD;
&#xD;
          -  Presence or history of unhealed cancer for more than five years, presence or history&#xD;
             of healed cancer for less than five years, except carcinoma in situ of the cervix or&#xD;
             basal cell carcinoma;&#xD;
&#xD;
          -  Pregnant or lactating women;&#xD;
&#xD;
          -  Men and women of childbearing age without effective contraception during the treatment&#xD;
             period;&#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>David Klatzmann, Pr</last_name>
    <role>Study Chair</role>
    <affiliation>APHP / CIC BTI / Hopital Pitie Salpétrière, Paris</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CIC Paris Est GH Pitié Salpétrière</name>
      <address>
        <city>Paris</city>
        <zip>75013</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>November 20, 2018</study_first_submitted>
  <study_first_submitted_qc>December 12, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 17, 2018</study_first_posted>
  <last_update_submitted>December 13, 2022</last_update_submitted>
  <last_update_submitted_qc>December 13, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 14, 2022</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>
  </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/NCT03776643
org study id: P 160936J
nct id: NCT03776643
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Several studies have reported a deficit and/or a defect in regulatory T cells in allergic
      subjects, which can be correlated with the allergic responses, especially for respiratory
      allergies. Low-dose IL-2 (ld-IL2) specifically targets and activates regulatory T cells
      (Tregs), which are cells that regulate immune responses. Thus by stimulating Tregs, ld-IL2
      would control allergic responses.

      This study is designed to evaluate the efficacy of ILT-101 (ld-IL-2), compared to placebo, on
      the nasal response assessed by Total Nasal Symptom Score (TNSS) during a controlled birch
      allergen exposure.
Primary objective To evaluate the efficacy of ILT-101 (ld-IL-2), compared to placebo, on
      nasal response on day 40

      Secondary objectives To evaluate the efficacy of ILT-101 on rhino-conjunctivitis symptoms, on
      inflammatory mediators, allergic specific immune responses and safety.

      Experimental design This is a monocentric, randomized, placebo controlled, double-blind trial
      in parallel-groups, evaluating a treatment by ILT-101/placebo, 1 MIU daily for 5 days and 1
      MIU every week, until day 36.

      Population involved Male or female, aged between 18 and 55 years, with allergic rhinitis to
      birch pollen.

      Number of subjects: 24

      Duration of patient participation: 3 months (treatment period: 36 days months, follow-up
      period: 34 days)
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Safety/Efficacy
primary purpose: Treatment
masking: Double (Participant, Investigator)
masking description: Double Blind
measure: Change in nasal congestion expressed as area under the curve (AUC), during birch allergen exposure in ALYATEC's Environmental Exposure Chamber (EEC)
time frame: on day 40
description: Change in nasal congestion expressed as area under the curve (AUC), during birch allergen exposure in ALYATEC's Environmental Exposure Chamber (EEC)
measure: Change in nasal congestion expressed as area under the curve (AUC), assessed during 4 hours of exposure
time frame: at Day 8
description: TNSS, expressed as area under the curve (AUC), assessed during 4 hours of exposure: TOTAL NASAL SYMPTOM SCORE Definition of response choices (drop down menu for each of the 4 questions below) 0 = None 1 = Mild (symptom clearly present but easily tolerated) 2 = Moderate (annoying but tolerable symptom) 3 = Severe (difficult to tolerate symptom, disrupts activities)
measure: Change in nasal response intensity
time frame: at Day 8
description: determined by Visual Analogue Scale (VAS) ranged from 0 to 10 cm where higher values correspond to more intense symptoms
measure: Changes in Tregs expressed in percentag (%)
time frame: at day 8
description: Changes in Tregs in percentag compared to baseline
measure: Changes in Tregs expressed in percentag (%)
time frame: at day 40
description: Changes in Tregs in percentag compared to baseline
measure: Changes in Tregs expressed in percentag (%)
time frame: at day 70
description: Changes in Tregs in percentag compared to baseline
measure: Changes in absolute count in Tregs
time frame: at day 8
description: Changes in absolute count in Tregs compared to baseline
measure: Changes in absolute count in Tregs
time frame: at day 40
description: Changes in absolute count in Tregs compared to baseline
measure: Changes in absolute count in Tregs
time frame: at day 70
description: Changes in absolute count in Tregs compared to baseline
measure: Changes in eosinophils expressed in percentag (%)
time frame: at day 8
description: Changes in eosinophils in percentag compared to baseline
measure: Changes in eosinophils expressed in percentag (%)
time frame: at day 40
description: Changes in eosinophils in percentag compared to baseline
measure: Changes in eosinophils expressed in percentag (%)
time frame: at day 70
description: Changes in eosinophils in percentag compared to baseline
measure: Changes in absolute count in eosinophils
time frame: at day 8
description: Changes in absolute count in eosinophils compared to baseline
measure: Changes in absolute count in eosinophils
time frame: at day 40
description: Changes in absolute count in eosinophils compared to baseline
measure: Changes in absolute count in eosinophils
time frame: at day 70
description: Changes in absolute count in eosinophils compared to baseline
measure: Changes in Inate Lymphoid Cell type 2(ILC2) expressed in percentag (%)
time frame: at day 8
description: Changes in Inate Lymphoid Cell type 2 in percentag compared to baseline
measure: Changes in Inate Lymphoid Cell type 2(ILC2) expressed in percentag (%)
time frame: at day 40
description: Changes in Inate Lymphoid Cell type 2 in percentag compared to baseline
measure: Changes in Inate Lymphoid Cell type 2(ILC2) expressed in percentag (%)
time frame: at day 70
description: Changes in Inate Lymphoid Cell type 2 in percentag compared to baseline
measure: Changes in absolute count in Inate Lymphoid Cell type 2(ILC2)
time frame: at day 8
description: Changes (in absolute count in Inate Lymphoid Cell type 2 compared to baseline
measure: Changes in absolute count in Inate Lymphoid Cell type 2(ILC2)
time frame: at day 40
description: Changes (in absolute count in Inate Lymphoid Cell type 2 compared to baseline
measure: Changes in absolute count in Inate Lymphoid Cell type 2(ILC2)
time frame: at day 70
description: Changes (in absolute count in Inate Lymphoid Cell type 2 compared to baseline
measure: Changes of antigen-specific T-cell immune responses (cytokine IL-4 )
time frame: at day 40
description: cytokine IL-4 at day 40
measure: Changes of antigen-specific T-cell immune responses (cytokine IL-4 )
time frame: at day 70
description: cytokine IL-4 at day 70
measure: Changes of antigen-specific T-cell immune responses (cytokine IL-5)
time frame: at day 40
description: cytokine IL-5 at day 40
measure: Changes of antigen-specific T-cell immune responses (cytokine IL-5)
time frame: at day 70
description: cytokine IL-5 at day 70
measure: Changes of antigen-specific T-cell immune responses
time frame: at day 40
description: IL-13 secretion after antigen restimulation at day 40
measure: Changes of antigen-specific T-cell immune responses
time frame: at day 70
description: IL-13 secretion after antigen restimulation at day 70
measure: Changes in allergen-specific IgE dosages basophil activation test with pollen allergen
time frame: at day 40
description: allergen-specific IgE dosages at day 40
measure: Incidence of adverse events at day 8
time frame: up to Day 8
description: Adverse events throughout the study (according to NCI-CTC AE classification)
measure: Incidence of adverse events at day 40
time frame: up to Day 40
description: Adverse events throughout the study (according to NCI-CTC AE classification)
measure: Incidence of adverse events at 70
time frame: up to Day 70
description: Adverse events throughout the study (according to NCI-CTC AE classification)
arm group label: ILT-101 (ld-IL2)
arm group type: Experimental
description: Subcutaneous injections of ILT-101
arm group label: placebo
arm group type: Placebo Comparator
description: Subcutaneous injections of placebo
intervention type: Drug
intervention name: ILT-101 ld-(IL2)
description: Subcutaneous injections of ILT-101 or Placebo starting with once-daily administration for 5 consecutive days followed by once every two weeks administration during five months
arm group label: ILT-101 (ld-IL2)
arm group label: placebo
other name: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: No
last name: David Klatzmann, Pr
role: Study Chair
affiliation: APHP / CIC BTI / Hopital Pitie Salpétrière, Paris
facility: 
country: France
responsible party type: Sponsor
mesh term: Rhinitis, Allergic, Seasonal