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/NCT05979051</url>
    </required_header>
    <id_info>
      <org_study_id>SHR-1703-301</org_study_id>
      <nct_id>NCT05979051</nct_id>
    </id_info>
    <brief_title>A Study to Evaluate the Efficacy and Safety of SHR-1703 in Subjects With Eosinophilic Granulomatosis With Polyangiitis （EGPA）</brief_title>
    <official_title>A Single-arm/Randomized, Double-blind, Placebo-controlled, Parallel-group Phase 2/3 Clinical Study to Evaluate the Efficacy and Safety of SHR-1703 for Patients With EGPA</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Guangdong Hengrui Pharmaceutical Co., Ltd</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Guangdong Hengrui Pharmaceutical Co., Ltd</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>
        This study is a phase 2/3 clinical trial to evaluate the efficacy and safety of SHR-1703 in&#xD;
        patients with EGPA.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 15, 2023</start_date>
    <completion_date type="Anticipated">May 16, 2027</completion_date>
    <primary_completion_date type="Anticipated">March 21, 2026</primary_completion_date>
    <phase>Phase 2/Phase 3</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Non-Randomized</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <intervention_model_description>A single-arm/randomized, double-blind, placebo-controlled, parallel-group Phase 2/3 clinical study.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change from baseline in oral glucocorticoid dose (OCS)</measure>
      <time_frame>Up to week 12</time_frame>
      <description>Phase 2</description>
    </primary_outcome>
    <primary_outcome>
      <measure>The Proportion of subjects in EGPA remission</measure>
      <time_frame>week 36 and week 48</time_frame>
      <description>Phase 3</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change from baseline in oral glucocorticoid dose</measure>
      <time_frame>Up to week 24</time_frame>
      <description>Effectiveness Indicators (Phase 2)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The proportion of subjects with OCS dosage ≤5 mg/d</measure>
      <time_frame>week 12, week 24</time_frame>
      <description>Effectiveness Indicators (Phase 2)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The proportion of subjects with at least 50% reduction of OCS dosage from baseline</measure>
      <time_frame>week 12, week 24</time_frame>
      <description>Effectiveness Indicators (Phase 2)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The Proportion of subjects with EGPA remission</measure>
      <time_frame>week 12, week 24</time_frame>
      <description>Effectiveness Indicators (Phase 2)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The Proportion of subjects with EGPA relapse</measure>
      <time_frame>week 12, week 24</time_frame>
      <description>Effectiveness Indicators (Phase 2)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The Proportion of subjects with Severe relapse of EGPA</measure>
      <time_frame>week 12, week 24</time_frame>
      <description>Effectiveness Indicators (Phase 2)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The Proportion of subjects in EULAR remission</measure>
      <time_frame>week 12 through week 24</time_frame>
      <description>Effectiveness Indicators (Phase 2)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The time to the first relapse of EGPA</measure>
      <time_frame>Up to week 48</time_frame>
      <description>Effectiveness Indicators (Phase 2)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The time of the first Severe relapse of EGPA</measure>
      <time_frame>Up to week 48</time_frame>
      <description>Effectiveness Indicators (Phase 2)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes from baseline in Pre- and post-Bronchodilator FEV1</measure>
      <time_frame>Up to week 48</time_frame>
      <description>Effectiveness Indicators (Phase 2)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes from baseline in Pre- and post-Bronchodilator FEV 1% pred</measure>
      <time_frame>Up to week 48</time_frame>
      <description>Effectiveness Indicators (Phase 2)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes from baseline in Pre- and post-Bronchodilator FVC</measure>
      <time_frame>Up to week 48</time_frame>
      <description>Effectiveness Indicators (Phase 2)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from baseline in OCS</measure>
      <time_frame>Week 24, Week 48</time_frame>
      <description>Effectiveness indicators (Phase 3)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The proportion of subjects with OCS dosage ≤5 mg/d</measure>
      <time_frame>week 24, week 48</time_frame>
      <description>Effectiveness indicators (Phase 3)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The proportion of subjects with at least 50% reduction of OCS dosage from baseline</measure>
      <time_frame>week 24, week 48</time_frame>
      <description>Effectiveness indicators (Phase 3)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The total accrued duration of remission</measure>
      <time_frame>up to week 48</time_frame>
      <description>Effectiveness indicators (Phase 3)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The Proportion of subjects with EGPA relapse</measure>
      <time_frame>week 24, week 48</time_frame>
      <description>Effectiveness indicators (Phase 3)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The Proportion of subjects with Severe relapse of EGPA</measure>
      <time_frame>week 24, week 48</time_frame>
      <description>Effectiveness indicators (Phase 3)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The time to the first relapse of EGPA</measure>
      <time_frame>Up to week 48</time_frame>
      <description>Effectiveness indicators (Phase 3)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The time of the first Severe relapse occurred of EGPA</measure>
      <time_frame>Up to week 48</time_frame>
      <description>Effectiveness indicators (Phase 3)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The Proportion of subjects in EGPA remission</measure>
      <time_frame>week 24 through week 48</time_frame>
      <description>Effectiveness indicators (Phase 3)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes from baseline in Pre- and post-Bronchodilator FEV1</measure>
      <time_frame>Up to week 48</time_frame>
      <description>Effectiveness indicators (Phase 3)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes from baseline in Pre- and post-Bronchodilator FEV 1% pred</measure>
      <time_frame>Up to week 48</time_frame>
      <description>Effectiveness indicators (Phase 3)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes from baseline in Pre- and post-Bronchodilator FVC</measure>
      <time_frame>Up to week 48</time_frame>
      <description>Effectiveness indicators (Phase 3)</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">112</enrollment>
    <condition>Eosinophilic Granulomatosis With Polyangiitis</condition>
    <arm_group>
      <arm_group_label>Treatment group A</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>SHR-1703</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Treatment group B</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>SHR-1703 Placebo</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>SHR-1703</intervention_name>
      <description>SHR-1703 will be administered by Subcutaneous injection in Phase 2 and Phase 3.</description>
      <arm_group_label>Treatment group A</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>SHR-1703 Placebo</intervention_name>
      <description>SHR-1703 Placebo will be administered by Subcutaneous injection in Phase 3.</description>
      <arm_group_label>Treatment group B</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Male or female subjects age 18 years or older;&#xD;
  &#xD;
            2. Diagnosed with EGPA for at least 6 months;&#xD;
  &#xD;
            3. History of relapsing or refractory EGPA；&#xD;
  &#xD;
            4. Stable dose of oral prednisone of ≥7.5 mg/day (but not &gt;50 mg/day) for at least 4&#xD;
               weeks prior to randomization;&#xD;
  &#xD;
            5. If receiving immunosuppressive therapy (excluding cyclophosphamide), the dosage must&#xD;
               be stable within 4 weeks prior to randomization and during the study.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Subjects with other eosinophilic-related diseases;&#xD;
  &#xD;
            2. Diagnosed with granulomatosis with polyangiitis (GPA) or microscopic polyangiitis&#xD;
               (MPA).&#xD;
  &#xD;
            3. Life-threatening EGPA within 3 months prior to randomization;&#xD;
  &#xD;
            4. Malignancy history within 5 years prior to randomization;&#xD;
  &#xD;
            5. Immunodeficiency;&#xD;
  &#xD;
            6. Uncontrolled hypertension；&#xD;
  &#xD;
            7. Uncontrolled cerebrovascular and cardiovascular disease;&#xD;
  &#xD;
            8. parasitic infection within 6 months prior to randomization;&#xD;
  &#xD;
            9. Active infectious disease requiring clinical treatment within 4 weeks prior to&#xD;
               randomization;&#xD;
  &#xD;
           10. Subjects with a dose of oral prednisone of &gt;50 mg/day within 4 weeks prior to&#xD;
               randomization;&#xD;
  &#xD;
           11. Oral or intravenous cyclophosphamide therapy within 4 weeks prior to randomization;&#xD;
  &#xD;
           12. Intravenous or subcutaneous immunoglobulin within 12 weeks prior to randomization;&#xD;
  &#xD;
           13. Biological agents or TH2 cytokine inhibitors used within 12 weeks prior to&#xD;
               randomization or within 5 half-lives of the drug;&#xD;
  &#xD;
           14. Rituximab or alemtuzumab used within 12 months prior to randomization；&#xD;
  &#xD;
           15. Surgical plans that might affect the evaluation;&#xD;
  &#xD;
           16. Significant laboratory abnormalities；&#xD;
  &#xD;
           17. Prolonged QTc interval or other electrocardiogram abnormalities with significant&#xD;
               safety risk at screening;&#xD;
  &#xD;
           18. History of drug or substance abuse or alcohol abuse within 1 year prior to screening;&#xD;
  &#xD;
           19. Subjects participated another clinical study and received active drug within 30 days&#xD;
               or 5 half-lives of the drug prior to screening;&#xD;
  &#xD;
           20. Subjects is pregnant, lactating, or planning to be pregnant;&#xD;
  &#xD;
           21. Subjects have a known history of hypersensitivity or intolerance to anti-IL-5 mabs or&#xD;
               other biological agents;&#xD;
  &#xD;
           22. Other conditions unsuitable for participation in the study per investigator judgement.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Siai Sun</last_name>
      <phone>0518-82342973</phone>
      <email>siai.sun@hengrui.com</email>
    </overall_contact>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 30, 2023</study_first_submitted>
    <study_first_submitted_qc>July 30, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 7, 2023</study_first_posted>
    <last_update_submitted>July 30, 2023</last_update_submitted>
    <last_update_submitted_qc>July 30, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 7, 2023</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>Granulomatosis with Polyangiitis</mesh_term>
      <mesh_term>Systemic Vasculitis</mesh_term>
      <mesh_term>Churg-Strauss Syndrome</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</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/NCT05979051
  org study id: SHR-1703-301
  nct id: NCT05979051
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  This study is a phase 2/3 clinical trial to evaluate the efficacy and safety of SHR-1703 in
        patients with EGPA.
  allocation: Non-Randomized
  intervention model: Single Group Assignment
  intervention model description: A single-arm/randomized, double-blind, placebo-controlled, parallel-group Phase 2/3 clinical study.
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Change from baseline in oral glucocorticoid dose (OCS)
  time frame: Up to week 12
  description: Phase 2
  measure: The Proportion of subjects in EGPA remission
  time frame: week 36 and week 48
  description: Phase 3
  measure: Change from baseline in oral glucocorticoid dose
  time frame: Up to week 24
  description: Effectiveness Indicators (Phase 2)
  measure: The proportion of subjects with OCS dosage ≤5 mg/d
  time frame: week 12, week 24
  description: Effectiveness Indicators (Phase 2)
  measure: The proportion of subjects with at least 50% reduction of OCS dosage from baseline
  time frame: week 12, week 24
  description: Effectiveness Indicators (Phase 2)
  measure: The Proportion of subjects with EGPA remission
  time frame: week 12, week 24
  description: Effectiveness Indicators (Phase 2)
  measure: The Proportion of subjects with EGPA relapse
  time frame: week 12, week 24
  description: Effectiveness Indicators (Phase 2)
  measure: The Proportion of subjects with Severe relapse of EGPA
  time frame: week 12, week 24
  description: Effectiveness Indicators (Phase 2)
  measure: The Proportion of subjects in EULAR remission
  time frame: week 12 through week 24
  description: Effectiveness Indicators (Phase 2)
  measure: The time to the first relapse of EGPA
  time frame: Up to week 48
  description: Effectiveness Indicators (Phase 2)
  measure: The time of the first Severe relapse of EGPA
  time frame: Up to week 48
  description: Effectiveness Indicators (Phase 2)
  measure: Changes from baseline in Pre- and post-Bronchodilator FEV1
  time frame: Up to week 48
  description: Effectiveness Indicators (Phase 2)
  measure: Changes from baseline in Pre- and post-Bronchodilator FEV 1% pred
  time frame: Up to week 48
  description: Effectiveness Indicators (Phase 2)
  measure: Changes from baseline in Pre- and post-Bronchodilator FVC
  time frame: Up to week 48
  description: Effectiveness Indicators (Phase 2)
  measure: Change from baseline in OCS
  time frame: Week 24, Week 48
  description: Effectiveness indicators (Phase 3)
  measure: The proportion of subjects with OCS dosage ≤5 mg/d
  time frame: week 24, week 48
  description: Effectiveness indicators (Phase 3)
  measure: The proportion of subjects with at least 50% reduction of OCS dosage from baseline
  time frame: week 24, week 48
  description: Effectiveness indicators (Phase 3)
  measure: The total accrued duration of remission
  time frame: up to week 48
  description: Effectiveness indicators (Phase 3)
  measure: The Proportion of subjects with EGPA relapse
  time frame: week 24, week 48
  description: Effectiveness indicators (Phase 3)
  measure: The Proportion of subjects with Severe relapse of EGPA
  time frame: week 24, week 48
  description: Effectiveness indicators (Phase 3)
  measure: The time to the first relapse of EGPA
  time frame: Up to week 48
  description: Effectiveness indicators (Phase 3)
  measure: The time of the first Severe relapse occurred of EGPA
  time frame: Up to week 48
  description: Effectiveness indicators (Phase 3)
  measure: The Proportion of subjects in EGPA remission
  time frame: week 24 through week 48
  description: Effectiveness indicators (Phase 3)
  measure: Changes from baseline in Pre- and post-Bronchodilator FEV1
  time frame: Up to week 48
  description: Effectiveness indicators (Phase 3)
  measure: Changes from baseline in Pre- and post-Bronchodilator FEV 1% pred
  time frame: Up to week 48
  description: Effectiveness indicators (Phase 3)
  measure: Changes from baseline in Pre- and post-Bronchodilator FVC
  time frame: Up to week 48
  description: Effectiveness indicators (Phase 3)
  arm group label: Treatment group A
  arm group type: Experimental
  description: SHR-1703
  arm group label: Treatment group B
  arm group type: Placebo Comparator
  description: SHR-1703 Placebo
  intervention type: Drug
  intervention name: SHR-1703
  description: SHR-1703 will be administered by Subcutaneous injection in Phase 2 and Phase 3.
  arm group label: Treatment group A
  intervention type: Drug
  intervention name: SHR-1703 Placebo
  description: SHR-1703 Placebo will be administered by Subcutaneous injection in Phase 3.
  arm group label: Treatment group B
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Siai Sun
  phone: 0518-82342973
  email: siai.sun@hengrui.com
  responsible party type: Sponsor
  mesh term: Granulomatosis with Polyangiitis
  mesh term: Systemic Vasculitis
  mesh term: Churg-Strauss Syndrome
  sharing ipd: Undecided