<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/NCT04455581</url>
  </required_header>
  <id_info>
    <org_study_id>SHR-1209-201</org_study_id>
    <nct_id>NCT04455581</nct_id>
  </id_info>
  <brief_title>A Study to Determine the Safety, Tolerability, and Efficacy of SHR-1209 in Patients With Familial Hypercholesterolemia</brief_title>
  <official_title>Open-label, Single-arm, Multicentre Study to Evaluate Efficacy and Safety of SHR-1209 in Subjects With Homozygous Familial Hypercholesterolemia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jiangsu HengRui Medicine Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Jiangsu HengRui Medicine 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>
      The study is being conducted to evaluate the efficacy, safety and tolerability of SHR-1209 in&#xD;
      subjects with familial hypercholesterolemia. 8 eligible patients (aged ≥18 years) with&#xD;
      familial hypercholesterolemia, on stable maximum tolerable dose lipid-regulating therapy for&#xD;
      at least 28 days, to receive subcutaneous SHR-1209, follow up 8 weeks. The primary endpoint&#xD;
      was percentage change in LDL cholesterol from baseline at week 12 .&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">September 1, 2020</start_date>
  <completion_date type="Anticipated">August 31, 2021</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2021</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>Percent Change from Baseline in LDL-C at Week 12</measure>
    <time_frame>Week 12</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in LDL-C at Week 12</measure>
    <time_frame>Week 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline in LDL-C at the Mean of Weeks 10 and 12</measure>
    <time_frame>Weeks 10 and 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in LDL-C at the Mean of Weeks 10 and 12</measure>
    <time_frame>Weeks 10 and 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline in the Total Cholesterol at the Mean of Weeks 10 and 12</measure>
    <time_frame>Weeks 10 and 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline in the Total Cholesterol at Week 12</measure>
    <time_frame>Week 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline in HDL-C at the Mean of Weeks 10 and 12</measure>
    <time_frame>Weeks 10 and 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline in HDL-C at Week 12</measure>
    <time_frame>Week 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline in Non-HDL-C at the Mean of Weeks 10 and 12</measure>
    <time_frame>Weeks 10 and 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline in Non-HDL-C at Week 12</measure>
    <time_frame>Week 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline in Triglycerides at the Mean of Weeks 10 and 12</measure>
    <time_frame>Weeks 10 and 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline in Triglycerides at Week 12</measure>
    <time_frame>Week 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline in Apo B at the Mean of Weeks 10 and 12</measure>
    <time_frame>Weeks 10 and 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline in ApoB at Week 12</measure>
    <time_frame>Week 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline in Apo A1 at the Mean of Weeks 10 and 12</measure>
    <time_frame>Weeks 10 and 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline in Apo A1 at Week 12</measure>
    <time_frame>Week 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline in Lipo(a) at the Mean of Weeks 10 and 12</measure>
    <time_frame>Weeks 10 and 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline in Lipo(a) at Week 12</measure>
    <time_frame>Week 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of investigational product-related adverse events</measure>
    <time_frame>Weeks 12 and 20</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of ADA and Nab</measure>
    <time_frame>Week 20</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">8</enrollment>
  <condition>Familial Hypercholesterolemia</condition>
  <arm_group>
    <arm_group_label>Treatment group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>SHR-1209 administered by subcutaneous injection Atorvastatin or Rosuvastatin combined with Ezetimibe oral</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>SHR-1209</intervention_name>
    <description>SHR-1209 administered by subcutaneous injection Atorvastatin or Rosuvastatin combined with Ezetimibe oral</description>
    <arm_group_label>Treatment group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Males and females ≥ 18 years of age&#xD;
&#xD;
          -  Diagnosis of homozygous familial hypercholesterolemia&#xD;
&#xD;
          -  Stable lipid-lowering therapies for at least 28 days&#xD;
&#xD;
          -  LDL cholesterol ≥ 130 mg/dl (3.4 mmol/L)&#xD;
&#xD;
          -  Triglyceride ≤ 400 mg/dL (4.5 mmol/L)&#xD;
&#xD;
          -  Bodyweight of ≥ 40 kg at screening.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  LDL or plasma apheresis within 8 weeks prior to randomization&#xD;
&#xD;
          -  New York Heart Association (NYHA) class III or IV or last known left ventricular&#xD;
             ejection fraction &lt; 30%&#xD;
&#xD;
          -  Myocardial infarction, unstable angina, percutaneous coronary intervention, coronary&#xD;
             artery bypass graft or stroke within 3 months of randomization, Planned cardiac&#xD;
             surgery or revascularization, Uncontrolled cardiac arrhythmia&#xD;
&#xD;
          -  Liver transplant history.&#xD;
&#xD;
          -  Uncontrolled hypertension.&#xD;
&#xD;
          -  Moderate to severe renal dysfunction.&#xD;
&#xD;
          -  Active liver disease or hepatic dysfunction.&#xD;
&#xD;
          -  Known sensitivity to any of the products to be administered during dosing&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Bin Zhang, Medial Manager</last_name>
    <phone>+86 13671548369</phone>
    <email>zhangbin@hrglobe.cn</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Bo Zhu, Medical Director</last_name>
    <phone>+86 13380043088</phone>
    <email>zhubo@hrglobe.cn</email>
  </overall_contact_backup>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 29, 2020</study_first_submitted>
  <study_first_submitted_qc>June 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 2, 2020</study_first_posted>
  <last_update_submitted>June 29, 2020</last_update_submitted>
  <last_update_submitted_qc>June 29, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 2, 2020</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>Hyperlipoproteinemia Type II</mesh_term>
    <mesh_term>Hypercholesterolemia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04455581
org study id: SHR-1209-201
nct id: NCT04455581
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The study is being conducted to evaluate the efficacy, safety and tolerability of SHR-1209 in
      subjects with familial hypercholesterolemia. 8 eligible patients (aged ≥18 years) with
      familial hypercholesterolemia, on stable maximum tolerable dose lipid-regulating therapy for
      at least 28 days, to receive subcutaneous SHR-1209, follow up 8 weeks. The primary endpoint
      was percentage change in LDL cholesterol from baseline at week 12 .
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Percent Change from Baseline in LDL-C at Week 12
time frame: Week 12
measure: Change From Baseline in LDL-C at Week 12
time frame: Week 12
measure: Percent Change From Baseline in LDL-C at the Mean of Weeks 10 and 12
time frame: Weeks 10 and 12
measure: Change From Baseline in LDL-C at the Mean of Weeks 10 and 12
time frame: Weeks 10 and 12
measure: Percent Change From Baseline in the Total Cholesterol at the Mean of Weeks 10 and 12
time frame: Weeks 10 and 12
measure: Percent Change From Baseline in the Total Cholesterol at Week 12
time frame: Week 12
measure: Percent Change From Baseline in HDL-C at the Mean of Weeks 10 and 12
time frame: Weeks 10 and 12
measure: Percent Change From Baseline in HDL-C at Week 12
time frame: Week 12
measure: Percent Change From Baseline in Non-HDL-C at the Mean of Weeks 10 and 12
time frame: Weeks 10 and 12
measure: Percent Change From Baseline in Non-HDL-C at Week 12
time frame: Week 12
measure: Percent Change From Baseline in Triglycerides at the Mean of Weeks 10 and 12
time frame: Weeks 10 and 12
measure: Percent Change From Baseline in Triglycerides at Week 12
time frame: Week 12
measure: Percent Change From Baseline in Apo B at the Mean of Weeks 10 and 12
time frame: Weeks 10 and 12
measure: Percent Change From Baseline in ApoB at Week 12
time frame: Week 12
measure: Percent Change From Baseline in Apo A1 at the Mean of Weeks 10 and 12
time frame: Weeks 10 and 12
measure: Percent Change From Baseline in Apo A1 at Week 12
time frame: Week 12
measure: Percent Change From Baseline in Lipo(a) at the Mean of Weeks 10 and 12
time frame: Weeks 10 and 12
measure: Percent Change From Baseline in Lipo(a) at Week 12
time frame: Week 12
measure: Number of investigational product-related adverse events
time frame: Weeks 12 and 20
measure: Number of ADA and Nab
time frame: Week 20
arm group label: Treatment group
arm group type: Experimental
description: SHR-1209 administered by subcutaneous injection Atorvastatin or Rosuvastatin combined with Ezetimibe oral
intervention type: Drug
intervention name: SHR-1209
description: SHR-1209 administered by subcutaneous injection Atorvastatin or Rosuvastatin combined with Ezetimibe oral
arm group label: Treatment group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Bin Zhang, Medial Manager
phone: +86 13671548369
email: zhangbin@hrglobe.cn
last name: Bo Zhu, Medical Director
phone: +86 13380043088
email: zhubo@hrglobe.cn
responsible party type: Sponsor
mesh term: Hyperlipoproteinemia Type II
mesh term: Hypercholesterolemia
sharing ipd: No