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/NCT05967520</url>
    </required_header>
    <id_info>
      <org_study_id>JY-R105-201</org_study_id>
      <nct_id>NCT05967520</nct_id>
    </id_info>
    <brief_title>JMKX000189 for Moderate to Severe Active Systemic Lupus Erythematosus</brief_title>
    <official_title>A Phase IIa ,Randomized, Double-blind, Placebo-controlled, Dose-exploration Study of JMKX000189 in Treatment of Moderate to Severe Active Systemic Lupus Erythematosus</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Jemincare</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Jemincare</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The trial will evaluate pharmacodynamics，pharmacokinetics，safety，and efficacy of JMKX000189&#xD;
        versus placebo in participants with moderately to severely active systemic lupus&#xD;
        erythematosus (SLE) while receiving standard of care (SOC) treatment.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">July 27, 2023</start_date>
    <completion_date type="Anticipated">December 2025</completion_date>
    <primary_completion_date type="Anticipated">May 2025</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>Change in Total Lymphocyte Count From Baseline to Week 12</measure>
      <time_frame>Baseline,Week 12</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change from baseline to Week 4,8,12 and 16 in the modified SLEDAI (mSLEDAI) score</measure>
      <time_frame>Baseline, Week 4, 8,12, and 16</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Percentage of Participants Achieving a Systemic Lupus Erythematosus Responder Index-4 (SRI-4) Response at Week 4,8,12 and 16</measure>
      <time_frame>Baseline, Week 4, 8,12, and 16</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Percentage of Participants Achieving No worsening in Physician Global Assessment (PGA) of Disease Activity at Week 4,8,12 and 16, No worsening defined as an increase of PGA &lt; 0.3 Points from baseline</measure>
      <time_frame>Baseline, Week 4, 8,12, and 16</time_frame>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">48</enrollment>
    <condition>Lupus Erythematosus, Systemic</condition>
    <arm_group>
      <arm_group_label>JMKX000189 - higher dose</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Randomized 16 patients will be received JMKX000189 at a higher dose in oral continuously from Week 0 to Week 12 in addition to SOC.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>JMKX000189 - lower dose</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Randomized 16 patients will be received JMKX000189 at a lower dose in oral continuously from Week 0 to Week 12 in addition to SOC.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Randomized 16 patients will be received Placebo in oral continuously from Week 0 to Week 12 in addition to SOC.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>JMKX000189</intervention_name>
      <description>JMKX000189 will be administered orally once a day</description>
      <arm_group_label>JMKX000189 - higher dose</arm_group_label>
      <arm_group_label>JMKX000189 - lower dose</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>Placebo will be administered orally once a day</description>
      <arm_group_label>Placebo</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Subjects must have been diagnosed with systemic lupus erythematosus at least 24 weeks&#xD;
               prior to screening and must be assessed to meet 2019 EULAR/ACR SLE classification&#xD;
               criteria during screening.&#xD;
  &#xD;
            2. the subject must meet one of the following at screening: a. ANA titer ≥1:80;b.&#xD;
               anti-dsDNA antibody positive; c. Anti-Smith antibody positive.&#xD;
  &#xD;
            3. At least one of the following SLE background standard therapies (including no more&#xD;
               than one immunosuppressant) was required for 12 weeks prior to randomization, and the&#xD;
               dose must remain stable at least 30 days until randomization and throughout study&#xD;
               participation.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Active lupus nephritis (defined as urinary protein &gt;1g/24 h or urinary total&#xD;
               protein/creatinine ratio (UPCR) &gt;1 mg/mg (113 mg/mmol) within 8 weeks prior to&#xD;
               screening or at randomization).&#xD;
  &#xD;
            2. Active lupus of the central nervous system (CNS) (including epilepsy, psychosis,&#xD;
               organic encephalopathy syndrome, cerebrovascular accident, encephalitis, or CNS&#xD;
               vasculitis) within 60 days prior to randomization.&#xD;
  &#xD;
            3. Myocardial infarction, unstable angina pectoris, stroke, transient ischemic attack,&#xD;
               decompensated heart failure requiring hospitalization, grade III/IV heart failure, or&#xD;
               untreated severe sleep apnea occurred ≤6 months before screening.&#xD;
  &#xD;
            4. Previous or current atrioventricular block of degree Ⅱ or Ⅲ, sick sinus syndrome,&#xD;
               symptomatic bradycardia, atrial flutter or atrial fibrillation, ventricular arrhythmia&#xD;
               or syncope associated with heart disease, or other arrhythmia deemed clinically&#xD;
               significant and requiring intervention or treatment.&#xD;
  &#xD;
            5. A history of severe respiratory disease or interstitial pneumonia or pulmonary&#xD;
               fibrosis，which were found by the medical history or lung function test or chest CT&#xD;
               examination conducted during screening or within 3 months prior to screening;Or&#xD;
               abnormal pulmonary function of medical significance: 1 second forced expiratory volume&#xD;
               (FEV1) or forced vital capacity (FVC)&lt;70% of the expected value, or FEV1 /FVC &lt; 0.7.&#xD;
  &#xD;
            6. Patients with significant abnormalities in liver, renal function and blood routine&#xD;
               during screening, including glutamate aminotransferase (ALT) or aspartate&#xD;
               aminotransferase (AST) exceeding 2 times the upper limit of normal value;Serum&#xD;
               creatinine greater than 1.5 times the upper limit of normal;Hemoglobin &lt;90g/L;White&#xD;
               blood cell count &lt;2.5×109/L, platelet count (PLT) &lt;75×109/L;Lymphocyte count&#xD;
               &lt;0.8×109/L;Abnormal results of other laboratory tests may affect the completion of the&#xD;
               test or interfere with the test results according to the investigator.&#xD;
  &#xD;
            7. Use of cyclosporine, tacrolimus, pimelimus, and sirolimus within 1 month prior to&#xD;
               randomization.&#xD;
  &#xD;
            8. Use of thalidomide or lenalidomide within 2 months prior to randomization.&#xD;
  &#xD;
            9. Rituximab, telitacicept, or leflunomide were used in the 6 months prior to&#xD;
               randomization.&#xD;
  &#xD;
           10. Use of Belliumab within 3 months prior to randomization.&#xD;
  &#xD;
           11. Intravenous treatment with cyclophosphamide was received within 6 months prior to&#xD;
               randomization or oral treatment with cyclophosphamide within 30 days prior to initial&#xD;
               administration.&#xD;
  &#xD;
           12. History of type 1 diabetes mellitus, or uncontrolled Type 2 diabetes mellitus with&#xD;
               HbA1c&gt; 8%, or diabetic subjects with organ involvement (e.g. retinopathy or kidney&#xD;
               disease).&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Xiaofeng Zeng</last_name>
      <role>Principal Investigator</role>
      <affiliation>Peking Union Medical College Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Quanquan Yan</last_name>
      <phone>+86 16602106063</phone>
      <email>yanquanquan@jemincare.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Yahui Li</last_name>
      <phone>+86 13311680015</phone>
      <email>liyahui@jemincare.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>The First Affiliated Hospital of Bengbu Medical College</name>
        <address>
          <city>Bengbu</city>
          <state>Anhui</state>
          <zip>233004</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Xuanwu Hospital, Capital Medical University</name>
        <address>
          <city>Beijing</city>
          <state>Beijing</state>
          <zip>100053</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Peking Union Medical College Hospital</name>
        <address>
          <city>Beijing</city>
          <state>Beijing</state>
          <zip>100730</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>The First Affiliated Hospital, Sun Yat-sen University</name>
        <address>
          <city>Guangzhou</city>
          <state>Guangdong</state>
          <zip>510080</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>The First Affiliated Hospital of Henan University of science and Technology</name>
        <address>
          <city>Luoyang</city>
          <state>Henan</state>
          <zip>471003</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Xinxiang Central Hospital</name>
        <address>
          <city>Xinxiang</city>
          <state>Henan</state>
          <zip>453099</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Union Hospital, Tongji Medical College, Huazhong University of Science and Technology</name>
        <address>
          <city>Wuhan</city>
          <state>Hubei</state>
          <zip>430022</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Jiangsu Province Hospital</name>
        <address>
          <city>Nanjing</city>
          <state>Jiangsu</state>
          <zip>210029</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Pingxiang People's Hospital</name>
        <address>
          <city>Pingxiang</city>
          <state>Jiangxi</state>
          <zip>337055</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>China-Japan Union Hospital of Jilin University</name>
        <address>
          <city>Changchun</city>
          <state>Jilin</state>
          <zip>130033</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Binzhou Medical University Hospital</name>
        <address>
          <city>Binzhou</city>
          <state>Shandong</state>
          <zip>256603</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Qilu Hospital of Shandong University</name>
        <address>
          <city>Jinan</city>
          <state>Shandong</state>
          <zip>250012</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Jining First People's Hospital</name>
        <address>
          <city>Jining</city>
          <state>Shandong</state>
          <zip>272002</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Huashan Hospital Affiliated to Fudan University</name>
        <address>
          <city>Shanghai</city>
          <state>Shanghai</state>
          <zip>200040</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine</name>
        <address>
          <city>Shanghai</city>
          <state>Shanghai</state>
          <zip>200127</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Shanxi Bethune Hospital</name>
        <address>
          <city>Taiyuan</city>
          <state>Shanxi</state>
          <zip>030032</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>West China Hospital Sichuan University</name>
        <address>
          <city>Chengdu</city>
          <state>Sichuan</state>
          <zip>610041</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 21, 2023</study_first_submitted>
    <study_first_submitted_qc>July 30, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 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 1, 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>Lupus Erythematosus, Systemic</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/NCT05967520
  org study id: JY-R105-201
  nct id: NCT05967520
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The trial will evaluate pharmacodynamics，pharmacokinetics，safety，and efficacy of JMKX000189
        versus placebo in participants with moderately to severely active systemic lupus
        erythematosus (SLE) while receiving standard of care (SOC) treatment.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  measure: Change in Total Lymphocyte Count From Baseline to Week 12
  time frame: Baseline,Week 12
  measure: Change from baseline to Week 4,8,12 and 16 in the modified SLEDAI (mSLEDAI) score
  time frame: Baseline, Week 4, 8,12, and 16
  measure: Percentage of Participants Achieving a Systemic Lupus Erythematosus Responder Index-4 (SRI-4) Response at Week 4,8,12 and 16
  time frame: Baseline, Week 4, 8,12, and 16
  measure: Percentage of Participants Achieving No worsening in Physician Global Assessment (PGA) of Disease Activity at Week 4,8,12 and 16, No worsening defined as an increase of PGA < 0.3 Points from baseline
  time frame: Baseline, Week 4, 8,12, and 16
  arm group label: JMKX000189 - higher dose
  arm group type: Experimental
  description: Randomized 16 patients will be received JMKX000189 at a higher dose in oral continuously from Week 0 to Week 12 in addition to SOC.
  arm group label: JMKX000189 - lower dose
  arm group type: Experimental
  description: Randomized 16 patients will be received JMKX000189 at a lower dose in oral continuously from Week 0 to Week 12 in addition to SOC.
  arm group label: Placebo
  arm group type: Placebo Comparator
  description: Randomized 16 patients will be received Placebo in oral continuously from Week 0 to Week 12 in addition to SOC.
  intervention type: Drug
  intervention name: JMKX000189
  description: JMKX000189 will be administered orally once a day
  arm group label: JMKX000189 - higher dose
  arm group label: JMKX000189 - lower dose
  intervention type: Drug
  intervention name: Placebo
  description: Placebo will be administered orally once a day
  arm group label: Placebo
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: No
  last name: Xiaofeng Zeng
  role: Principal Investigator
  affiliation: Peking Union Medical College Hospital
  last name: Quanquan Yan
  phone: +86 16602106063
  email: yanquanquan@jemincare.com
  last name: Yahui Li
  phone: +86 13311680015
  email: liyahui@jemincare.com
  facility: 
  status: Not yet recruiting
  facility: 
  status: Not yet recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Not yet recruiting
  facility: 
  status: Not yet recruiting
  facility: 
  status: Not yet recruiting
  facility: 
  status: Not yet recruiting
  facility: 
  status: Not yet recruiting
  facility: 
  status: Not yet recruiting
  facility: 
  status: Not yet recruiting
  facility: 
  status: Not yet recruiting
  facility: 
  status: Not yet recruiting
  facility: 
  status: Not yet recruiting
  facility: 
  status: Not yet recruiting
  facility: 
  status: Not yet recruiting
  facility: 
  status: Not yet recruiting
  facility: 
  status: Not yet recruiting
  country: China
  responsible party type: Sponsor
  mesh term: Lupus Erythematosus, Systemic
  sharing ipd: No