xml: <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/NCT06028490</url>
    </required_header>
    <id_info>
      <org_study_id>2081-IIT-SAR</org_study_id>
      <nct_id>NCT06028490</nct_id>
    </id_info>
    <brief_title>A Study of IL4Rα Monoclonal Antibody in Patients With Uncontrolled Seasonal Allergic Rhinitis.</brief_title>
    <official_title>The Efficacy and Safety of IL4Rα Monoclonal Antibody in Patients With Uncontrolled Seasonal Allergic Rhinitis Under Conventional Treatment: A Randomized, Double-Blind, Placebo-controlled Investigator Initiated Trial.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Zheng Liu ENT</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Tongji Hospital</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Allergic rhinitis (AR) is a non-infectious chronic inflammatory disease of the nasal mucosa&#xD;
        mainly mediated by immunoglobulin E after exposure to allergens in atopic individuals. The&#xD;
        typical symptoms of AR are paroxysmal sneezing, watery rhinorrhea, itching, and nasal&#xD;
        congestion, which may be accompanied by ocular symptoms, including eye itching, tearing,&#xD;
        redness, and burning sensation, which are more common in patients with hay fever allergies.&#xD;
        Bronchial asthma is associated with bronchial asthma in 40% of patients with AR, suggesting a&#xD;
        comorbid feature of allergic disease.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">September 7, 2023</start_date>
    <completion_date type="Anticipated">November 2023</completion_date>
    <primary_completion_date type="Anticipated">November 2023</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>Average change from baseline in daily retrospective total nasal symptom score (rTNSS) during treatment period.</measure>
      <time_frame>week 4</time_frame>
      <description>The Total Nasal Symptom Score (TNSS) is the sum of the four symptom scores of runny nose, nasal congestion, nasal itching, and sneezing, with each symptom scoring from 0 to 3.</description>
    </primary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">90</enrollment>
    <condition>Allergic Rhinitis</condition>
    <arm_group>
      <arm_group_label>Interleukin-4 receptor responders 1</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Recombinant fully human anti-IL4Rα monoclonal antibody drug.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Interleukin-4 receptor responders 2</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Recombinant fully human anti-IL4Rα monoclonal antibody drug.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Recombinant fully human anti-IL4Rα monoclonal antibody drug.</description>
    </arm_group>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>GR1802 injection-1</intervention_name>
      <description>subcutaneous，dose*1</description>
      <arm_group_label>Interleukin-4 receptor responders 1</arm_group_label>
      <other_name>Xeligekimab</other_name>
    </intervention>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>GR1802 injection-2</intervention_name>
      <description>subcutaneous，dose*2</description>
      <arm_group_label>Interleukin-4 receptor responders 2</arm_group_label>
      <other_name>Xeligekimab</other_name>
    </intervention>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>subcutaneous，dose*2</description>
      <arm_group_label>Placebo</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Key Inclusion Criteria:&#xD;
  &#xD;
            1. Subjects meet the diagnosis of SAR which has been prevalent for at least 2 years, and:&#xD;
               standard treatment regimen for SAR was ineffective or subjective symptom control was&#xD;
               unsatisfactory in the subject; positive test for at least one allergen associated with&#xD;
               the development of SAR; pre-baseline symptom episodes of ≥ 4 days/week and a baseline&#xD;
               TNSS of ≥ 6 points.&#xD;
  &#xD;
            2. Consent to highly effective contraception&#xD;
  &#xD;
          Key Exclusion Criteria:&#xD;
  &#xD;
            1. Other nasal comorbidities or co-morbidities/states that may be present at the time of&#xD;
               screening；&#xD;
  &#xD;
            2. It is expected that subjects' exposure to allergens in their home or work environments&#xD;
               may change significantly during the study period.&#xD;
  &#xD;
            3. Patients with asthma requiring stable use of inhaled controlled medications;&#xD;
  &#xD;
            4. Previous or current malignant tumor within 5 years prior to screening;&#xD;
  &#xD;
            5. Presence of other acute or chronic diseases or abnormal laboratory tests at the time&#xD;
               of screening that, in the investigator's assessment, may have a more serious impact on&#xD;
               the efficacy or safety assessment of the subject;&#xD;
  &#xD;
            6. Live/live attenuated vaccine within 3 months prior to baseline;&#xD;
  &#xD;
            7. Subjects with very limited outdoor activity during the daytime, as inferred from their&#xD;
               regular daily routine;&#xD;
  &#xD;
            8. Unwillingness or inability to comply with the permitted and prohibited&#xD;
               medication/treatment specifications of the study, inability to meet the&#xD;
               pre-randomization drug elution cycle specified in the protocol;&#xD;
  &#xD;
            9. Women who are pregnant or breastfeeding;&#xD;
  &#xD;
           10. History of alcohol or drug abuse within 3 months prior to screening.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Zheng Liu, PHD</last_name>
      <phone>027-83665555</phone>
      <email>zhengliuent@hotmail.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Rong fei Zhu, PHD</last_name>
      <phone>027-83665555</phone>
      <email>zrf13092@163.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Tongji Hosptial affiliated to Tongji Medical college of Huazhong University of Science and Technology</name>
        <address>
          <city>Wuhan</city>
          <state>Hubei</state>
          <zip>430030</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Rongfei Zhu</last_name>
        <phone>18986292602</phone>
        <email>zrf13092@163.com</email>
      </contact>
      <contact_backup>
        <last_name>Zheng liu</last_name>
        <phone>18607110505</phone>
        <email>zhengliuent@hotmail.com</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 31, 2023</study_first_submitted>
    <study_first_submitted_qc>September 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 8, 2023</study_first_posted>
    <last_update_submitted>September 7, 2023</last_update_submitted>
    <last_update_submitted_qc>September 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 11, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Tongji Hospital</investigator_affiliation>
      <investigator_full_name>Zheng Liu ENT</investigator_full_name>
      <investigator_title>Head of Otolaryngology, Principal Investigator, Clinical Professor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Rhinitis</mesh_term>
      <mesh_term>Rhinitis, Allergic</mesh_term>
      <mesh_term>Rhinitis, Allergic, Seasonal</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06028490
  org study id: 2081-IIT-SAR
  nct id: NCT06028490
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Allergic rhinitis (AR) is a non-infectious chronic inflammatory disease of the nasal mucosa
        mainly mediated by immunoglobulin E after exposure to allergens in atopic individuals. The
        typical symptoms of AR are paroxysmal sneezing, watery rhinorrhea, itching, and nasal
        congestion, which may be accompanied by ocular symptoms, including eye itching, tearing,
        redness, and burning sensation, which are more common in patients with hay fever allergies.
        Bronchial asthma is associated with bronchial asthma in 40% of patients with AR, suggesting a
        comorbid feature of allergic disease.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  measure: Average change from baseline in daily retrospective total nasal symptom score (rTNSS) during treatment period.
  time frame: week 4
  description: The Total Nasal Symptom Score (TNSS) is the sum of the four symptom scores of runny nose, nasal congestion, nasal itching, and sneezing, with each symptom scoring from 0 to 3.
  arm group label: Interleukin-4 receptor responders 1
  arm group type: Experimental
  description: Recombinant fully human anti-IL4Rα monoclonal antibody drug.
  arm group label: Interleukin-4 receptor responders 2
  arm group type: Experimental
  description: Recombinant fully human anti-IL4Rα monoclonal antibody drug.
  arm group label: Placebo
  arm group type: Placebo Comparator
  description: Recombinant fully human anti-IL4Rα monoclonal antibody drug.
  intervention type: Biological
  intervention name: GR1802 injection-1
  description: subcutaneous，dose*1
  arm group label: Interleukin-4 receptor responders 1
  other name: Xeligekimab
  intervention type: Biological
  intervention name: GR1802 injection-2
  description: subcutaneous，dose*2
  arm group label: Interleukin-4 receptor responders 2
  other name: Xeligekimab
  intervention type: Biological
  intervention name: Placebo
  description: subcutaneous，dose*2
  arm group label: Placebo
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: No
  last name: Zheng Liu, PHD
  phone: 027-83665555
  email: zhengliuent@hotmail.com
  last name: Rong fei Zhu, PHD
  phone: 027-83665555
  email: zrf13092@163.com
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: China
  responsible party type: Sponsor-Investigator
  investigator affiliation: Tongji Hospital
  investigator full name: Zheng Liu ENT
  investigator title: Head of Otolaryngology, Principal Investigator, Clinical Professor
  mesh term: Rhinitis
  mesh term: Rhinitis, Allergic
  mesh term: Rhinitis, Allergic, Seasonal
  sharing ipd: No