<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/NCT04469673</url>
  </required_header>
  <id_info>
    <org_study_id>JS002-002</org_study_id>
    <nct_id>NCT04469673</nct_id>
  </id_info>
  <brief_title>A Study to Evaluate the Safety, Tolerability and Efficacy of Multiple Doses of JS002 in Patients With Hyperlipidemia..</brief_title>
  <official_title>A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability and Efficacy, as Well as Immunogenecity, Pharmacokineticks and Pharmacodynamics of Multiple Doses of JS002 on Stable Statin Therapy in Patients With Hyperlipidemia.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shanghai Junshi Bioscience Co., Ltd.</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shanghai Junshi Bioscience 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>
      JS002 is a recombinant humanized anti-PCSK9 monoclonal antibody.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 23, 2019</start_date>
  <completion_date type="Actual">June 28, 2020</completion_date>
  <primary_completion_date type="Actual">May 3, 2020</primary_completion_date>
  <phase>Phase 1/Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percent change from baseline in low-density lipoprotein cholesterol (LDL-C) to week 12</measure>
    <time_frame>12 weeks after the first dose</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Absolute value change from baseline in low-density lipoprotein cholesterol (LDL-C)</measure>
    <time_frame>Twelve weeks after the last dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent change from baseline in Total Cholesterol(TC、HDL-C、non-HDL-C、VLDL-C、Apo B、Apo A1、Lp(a) and TG )</measure>
    <time_frame>Twelve weeks after the last dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage change from baseline TC/HDL-C ratio</measure>
    <time_frame>Twelve weeks after the last dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent change from baseline in Apolipoprotein B (Apo B)</measure>
    <time_frame>Twelve weeks after the last dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent change from baseline in Apolipoprotein A-I (ApoA-I)</measure>
    <time_frame>Twelve weeks after the last dose</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Number of subjects who develop detectable anti-drug antibodies (ADAs)</measure>
    <time_frame>Twelve weeks after the last dose</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Serum concentrations of JS002</measure>
    <time_frame>Twelve weeks after the last dose</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Change from baseline in proprotein convertase total / free pcsk9</measure>
    <time_frame>Twelve weeks after the last dose</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">90</enrollment>
  <condition>Hyperlipemia</condition>
  <arm_group>
    <arm_group_label>JS002</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants received one of 3 dose regimens of JS002 administered as multiple subcutaneous doses.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants received matching placebo dose regimens by subcutaneous injection.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Biological：JS002</intervention_name>
    <description>Administered by subcutaneous injection</description>
    <arm_group_label>JS002</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Administered by subcutaneous injection</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Signed informed consent.&#xD;
&#xD;
          2. Age ≥18 and ≤65 years old;&#xD;
&#xD;
          3. Body mass index (BMI) ≥18 and ≤ 30 kg/m2;&#xD;
&#xD;
          4. Subjects who are receiving statin therapy at the time of screening or who are eligible&#xD;
             for statin therapy can receive a stable dose of statin therapy for more than 28 days&#xD;
             before randomization and are willing to maintain stable statin therapy during the&#xD;
             study;&#xD;
&#xD;
          5. Low-density lipoprotein cholesterol (LDL-C) level ≥2.6mmol/L for subjects who are&#xD;
             receiving statin and/or other lipid-lowering therapy at the time of screening, or&#xD;
             LDL-C≥ 4.1mmol/L for subjects who didn't receive any-lowering therapy at the time of&#xD;
             screening, and LDL-C still ≥2.6mmol/L before randomization;&#xD;
&#xD;
          6. Fasting triglycerides ≤4.5 mmol/L;&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Diagnosis of homozygous familial hypercholesterolemia;&#xD;
&#xD;
          2. History of New York heart association (NYHA) defined Ⅱ - Ⅳ heart failure;&#xD;
&#xD;
          3. History of uncontrolled arrhythmiast;&#xD;
&#xD;
          4. History of myocardial infarction, history of PTCA or PCI or CABG, history of unstable&#xD;
             angina befor 90 days of randomization;&#xD;
&#xD;
          5. History of stroke or TIA；&#xD;
&#xD;
          6. Uncontrolled hypertension with SBP≥160mmHg and/or DBP≥100mmHg&#xD;
&#xD;
          7. Type 1 diabetes, or type 2 diabetes that is or poorly controlled（HbA1c&gt; 8.0%);&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Fuwai Hospital Chinese Academy of Medical Sciences</name>
      <address>
        <city>Beijing</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 6, 2020</study_first_submitted>
  <study_first_submitted_qc>July 13, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 14, 2020</study_first_posted>
  <last_update_submitted>July 13, 2020</last_update_submitted>
  <last_update_submitted_qc>July 13, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 14, 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>Hyperlipidemias</mesh_term>
    <mesh_term>Hyperlipoproteinemias</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/NCT04469673
org study id: JS002-002
nct id: NCT04469673
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
JS002 is a recombinant humanized anti-PCSK9 monoclonal antibody.
allocation: Randomized
intervention model: Sequential Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Percent change from baseline in low-density lipoprotein cholesterol (LDL-C) to week 12
time frame: 12 weeks after the first dose
measure: Absolute value change from baseline in low-density lipoprotein cholesterol (LDL-C)
time frame: Twelve weeks after the last dose
measure: Percent change from baseline in Total Cholesterol(TC、HDL-C、non-HDL-C、VLDL-C、Apo B、Apo A1、Lp(a) and TG )
time frame: Twelve weeks after the last dose
measure: Percentage change from baseline TC/HDL-C ratio
time frame: Twelve weeks after the last dose
measure: Percent change from baseline in Apolipoprotein B (Apo B)
time frame: Twelve weeks after the last dose
measure: Percent change from baseline in Apolipoprotein A-I (ApoA-I)
time frame: Twelve weeks after the last dose
measure: Number of subjects who develop detectable anti-drug antibodies (ADAs)
time frame: Twelve weeks after the last dose
measure: Serum concentrations of JS002
time frame: Twelve weeks after the last dose
measure: Change from baseline in proprotein convertase total / free pcsk9
time frame: Twelve weeks after the last dose
arm group label: JS002
arm group type: Experimental
description: Participants received one of 3 dose regimens of JS002 administered as multiple subcutaneous doses.
arm group label: Placebo
arm group type: Placebo Comparator
description: Participants received matching placebo dose regimens by subcutaneous injection.
intervention type: Biological
intervention name: Biological：JS002
description: Administered by subcutaneous injection
arm group label: JS002
intervention type: Biological
intervention name: Placebo
description: Administered by subcutaneous injection
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
facility: 
country: China
responsible party type: Sponsor
mesh term: Hyperlipidemias
mesh term: Hyperlipoproteinemias