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/NCT06012812</url>
    </required_header>
    <id_info>
      <org_study_id>SHR-1819-203</org_study_id>
      <nct_id>NCT06012812</nct_id>
    </id_info>
    <brief_title>A Study to Extend Efficacy and Safety of SHR-1819 Injection in Adult Patients With Moderate to Severe Atopic Dermatitis</brief_title>
    <official_title>A Multicenter, Open-label, Extended Study Evaluating the Safety and Efficacy of SHR-1819 Injection in Adult Subjects With Moderate to Severe Atopic Dermatitis Who Have Previously Participated in SHR-1819 Studies for the Treatment of Atopic Dermatitis</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Shanghai Hengrui Pharmaceutical Co., Ltd.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Shanghai 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 multicenter, open-label, extended study to evaluate the safety, efficacy,&#xD;
        pharmacokinetics, and immunogenicity of SHR-1819 injection in adult subjects with moderate to&#xD;
        severe atopic dermatitis who have previously participated in the SHR-1819 injection study for&#xD;
        atopic dermatitis (defined as the main study, referred to as the main study hereinafter).&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 15, 2023</start_date>
    <completion_date type="Anticipated">May 30, 2025</completion_date>
    <primary_completion_date type="Anticipated">May 30, 2025</primary_completion_date>
    <phase>Phase 2</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Treatment Emergent Adverse Events (TEAEs) (per person-year)</measure>
      <time_frame>Up to 60 weeks</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Serious Adverse Event (SAE) during treatment (per person-year)</measure>
      <time_frame>Up to 60 weeks</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Adverse Events of Special Interest (AESI) during treatment (per person-year)</measure>
      <time_frame>Up to 60 weeks</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportion of participants with a Global Assessment (IGA) score of 0 or 1 (0-4 scale) per visit</measure>
      <time_frame>Up to 60 weeks</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time to first remission (remission defined as IGA = 1 or 0 after treatment) in this study (for participants visiting 2 baseline IGAs ≥2)</measure>
      <time_frame>Up to 60 weeks</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportion of participants with at least 1 remission in this study</measure>
      <time_frame>Up to 60 weeks</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time to first relapse in this study (relapse defined as IGA = 3 or 4 points after remission) (for participants with Visit 2 baseline IGA ≥ 2)</measure>
      <time_frame>Up to 60 weeks</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The concentration of SHR-1819 in serum :Cmax</measure>
      <time_frame>From the beginning of administration to the 60h week</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Immunogenic endpoint: evaluate the incidence and timing of ADA positivity for SHR-1819</measure>
      <time_frame>From the beginning of administration to the 60th week</time_frame>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">240</enrollment>
    <condition>Moderate to Severe Atopic Dermatitis</condition>
    <arm_group>
      <arm_group_label>SHR-1819 injection</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>SHR-1819 injection</intervention_name>
      <description>SHR-1819 injection 300 mg Q2W</description>
      <arm_group_label>SHR-1819 injection</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. The age of 18~75 years old at the time of signing the informed consent form (including&#xD;
               the values at both ends), gender is not limited；&#xD;
  &#xD;
            2. Previous atopic dermatitis, (1) participation in a complete main study; or (2)&#xD;
               subjects who prematurely terminate primary study therapy for reasons other than&#xD;
               SHR-1819 injection are required to complete a last safety follow-up or withdrawal from&#xD;
               the visit, and the investigator assesses that the influencing factor has been&#xD;
               eliminated/no longer affects the participant's participation in the extended study.&#xD;
               Participants were required to meet the main study inclusion criteria for the main&#xD;
               study；&#xD;
  &#xD;
            3. Be able to apply a topical emollient (moisturizer) continuously for at least 7&#xD;
               consecutive days before the first dose and continue to use it for the duration of the&#xD;
               study;&#xD;
  &#xD;
            4. Be able to sign informed consent forms, understand and agree to follow the&#xD;
               requirements of the study and the trial process.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Pregnant or lactating women；&#xD;
  &#xD;
            2. Female subjects of childbearing potential and male subjects whose partners are women&#xD;
               of childbearing age have a plan to donate sperm/eggs from the signing of the informed&#xD;
               consent form until 3 months after the last dose of the trial drug, or refuse to comply&#xD;
               with the relevant contraceptive requirements;&#xD;
  &#xD;
            3. A history of alcohol abuse or illicit drug abuse within 6 months prior to screening;&#xD;
  &#xD;
            4. Hypersensitivity to the study drug or any ingredient in the study drug；&#xD;
  &#xD;
            5. Diagnosed within 6 months prior to screening or judged by the investigator to have a&#xD;
               suspected immunosuppressive disease;&#xD;
  &#xD;
            6. Oral or parenteral systemic antimicrobials are used within 2 weeks before the first&#xD;
               dose；&#xD;
  &#xD;
            7. Suspected or confirmed active tuberculosis (TB);&#xD;
  &#xD;
            8. Have malignancy or history of malignancy prior to screening；&#xD;
  &#xD;
            9. Major surgery was performed within 3 months prior to screening, or major surgery was&#xD;
               planned during the study；&#xD;
  &#xD;
           10. There are currently significant abnormal laboratory test results, severe concomitant&#xD;
               diseases, and other circumstances that the investigator considers inappropriate to&#xD;
               participate in this trial;&#xD;
  &#xD;
           11. There were treatment-related adverse events leading to discontinuation of treatment&#xD;
               and study drug-related SAEs in the main study, and the investigator or sponsor medical&#xD;
               department considered that continuing to participate in extended therapy would pose an&#xD;
               unacceptable safety risk to participants.&#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>Guangchao Dong</last_name>
      <phone>0518-82342973</phone>
      <email>guangchao.dong@hengrui.com</email>
    </overall_contact>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 22, 2023</study_first_submitted>
    <study_first_submitted_qc>August 22, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 28, 2023</study_first_posted>
    <last_update_submitted>August 22, 2023</last_update_submitted>
    <last_update_submitted_qc>August 22, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 28, 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>Dermatitis, Atopic</mesh_term>
      <mesh_term>Dermatitis</mesh_term>
      <mesh_term>Eczema</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/NCT06012812
  org study id: SHR-1819-203
  nct id: NCT06012812
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  This study is a multicenter, open-label, extended study to evaluate the safety, efficacy,
        pharmacokinetics, and immunogenicity of SHR-1819 injection in adult subjects with moderate to
        severe atopic dermatitis who have previously participated in the SHR-1819 injection study for
        atopic dermatitis (defined as the main study, referred to as the main study hereinafter).
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Treatment Emergent Adverse Events (TEAEs) (per person-year)
  time frame: Up to 60 weeks
  measure: Serious Adverse Event (SAE) during treatment (per person-year)
  time frame: Up to 60 weeks
  measure: Adverse Events of Special Interest (AESI) during treatment (per person-year)
  time frame: Up to 60 weeks
  measure: Proportion of participants with a Global Assessment (IGA) score of 0 or 1 (0-4 scale) per visit
  time frame: Up to 60 weeks
  measure: Time to first remission (remission defined as IGA = 1 or 0 after treatment) in this study (for participants visiting 2 baseline IGAs ≥2)
  time frame: Up to 60 weeks
  measure: Proportion of participants with at least 1 remission in this study
  time frame: Up to 60 weeks
  measure: Time to first relapse in this study (relapse defined as IGA = 3 or 4 points after remission) (for participants with Visit 2 baseline IGA ≥ 2)
  time frame: Up to 60 weeks
  measure: The concentration of SHR-1819 in serum :Cmax
  time frame: From the beginning of administration to the 60h week
  measure: Immunogenic endpoint: evaluate the incidence and timing of ADA positivity for SHR-1819
  time frame: From the beginning of administration to the 60th week
  arm group label: SHR-1819 injection
  arm group type: Experimental
  intervention type: Drug
  intervention name: SHR-1819 injection
  description: SHR-1819 injection 300 mg Q2W
  arm group label: SHR-1819 injection
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: No
  last name: Guangchao Dong
  phone: 0518-82342973
  email: guangchao.dong@hengrui.com
  responsible party type: Sponsor
  mesh term: Dermatitis, Atopic
  mesh term: Dermatitis
  mesh term: Eczema
  sharing ipd: Undecided