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/NCT06015230</url>
    </required_header>
    <id_info>
      <org_study_id>GR1603-002</org_study_id>
      <nct_id>NCT06015230</nct_id>
    </id_info>
    <brief_title>Clinical Study to Investigate the Safety, Tolerability, and Pharmacokinetics of GR1603 in SLE</brief_title>
    <official_title>A Phase Ⅰb/Ⅱ, Randomized, Double-blind, Placebo-controlled Study to Investigate the Tolerability, Safety,Pharmacokinetics and Efficacy of an Intravenous Treatment Regimen of GR1603 in Subjects With Systemic Lupus Erythematosus</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Genrix (Shanghai) Biopharmaceutical Co., Ltd.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Genrix (Shanghai) Biopharmaceutical 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>
        A Study to Investigate the Tolerability, Safety,Pharmacokinetics and efficacy of GR1603 in&#xD;
        subjects with Systemic Lupus Erythematosus ； GR1603 injection is a monoclonal antibody&#xD;
        targeting IFNAR1, which can block IFNAR binding to type I interferons such as IFNα and be&#xD;
        used to treat systemic lupus erythematosus.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is a Phase Ib/Ⅱ,double blind, multiple-dose study to evaluate the pharmacokinetics (PK),&#xD;
        safety，tolerability and efficacy of intravenously administered GR1603 in participants with&#xD;
        active SLE despite receiving standard of care .&#xD;
  &#xD;
        Phase Ib is a multi-dose escalation phase in which 16 subjects are scheduled to enroll.&#xD;
  &#xD;
        A total of 120 subjects were randomly assigned to GR1603 injection low dose group, high dose&#xD;
        group or placebo group in phase Ⅱ.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">March 8, 2022</start_date>
    <completion_date type="Anticipated">October 4, 2028</completion_date>
    <primary_completion_date type="Anticipated">June 10, 2028</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>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Adverse events(phase Ib)</measure>
      <time_frame>up to week 16</time_frame>
      <description>to characterise the safety and tolerability of GR1603,including abnormal vital signs,laboratory tests,electrocardiogram and physical examination</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of participants who achieved BICLA response (phase Ⅱ)</measure>
      <time_frame>week 24</time_frame>
      <description>BICLA respnse:reduction of all baseline BILAG-2004 A to B/C/D and baseline BILAG-2004 B to C/D, and no BILAG-2004 worsening in other organ systems, as defined by ≥1 new BILAG-2004 A or ≥2 new BILAG-2004 B</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Cmax(phaseⅠb）</measure>
      <time_frame>up to week 16</time_frame>
      <description>Pharmacokinetic indices</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>AUC0-t(phaseⅠb）</measure>
      <time_frame>up to week 16</time_frame>
      <description>Pharmacokinetic indices</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>AUC0-∞(phaseⅠb）</measure>
      <time_frame>up to week 16</time_frame>
      <description>Pharmacokinetic indices</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>AUCss(phaseⅠb）</measure>
      <time_frame>up to week 16</time_frame>
      <description>Pharmacokinetic indices</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Tmax(phaseⅠb）</measure>
      <time_frame>up to week 16</time_frame>
      <description>Pharmacokinetic indices</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>t1/2z(phaseⅠb）</measure>
      <time_frame>up to week 16</time_frame>
      <description>Pharmacokinetic indices</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Vz(phaseⅠb）</measure>
      <time_frame>up to week 16</time_frame>
      <description>Pharmacokinetic indices</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>CLz(phaseⅠb）</measure>
      <time_frame>up to week 16</time_frame>
      <description>Pharmacokinetic indices</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of participants who achieved SRI (4)(phase Ⅱ)</measure>
      <time_frame>up to week 28</time_frame>
      <description>An SRI (4) responder defined as a participant who had a reduction in baseline Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score of greater than or equal to 4 points;</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of participants who achieved BICLA response(phase Ⅱ)</measure>
      <time_frame>up to week 28</time_frame>
      <description>BICLA respnse:reduction of all baseline BILAG-2004 A to B/C/D and baseline BILAG-2004 B to C/D, and no BILAG-2004 worsening in other organ systems, as defined by ≥1 new BILAG-2004 A or ≥2 new BILAG-2004 B</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of participants with a ≥50% reduction in CLASI activity score (phase Ⅱ)</measure>
      <time_frame>up to week 28</time_frame>
      <description>CLASI:Cutaneous Lupus Erythematosus Disease Area and Severity Index</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Flare rate(phase Ⅱ）</measure>
      <time_frame>up to week 28</time_frame>
      <description>A flare was defined as either 1 or more new BILAG-2004 A or 2 or more new BILAG-2004 B items compared to the previous visit</description>
    </secondary_outcome>
    <number_of_arms>5</number_of_arms>
    <enrollment type="Anticipated">136</enrollment>
    <condition>Lupus Erythematosus, Systemic</condition>
    <arm_group>
      <arm_group_label>Treatment group 1-Ⅰb</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>6 subjects in GR1603 low dose，2 subjects in placebo</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Treatment group 2-Ⅰb</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>6 subjects in GR1603 high dose，2 subjects in placebo</description>
    </arm_group>
    <arm_group>
      <arm_group_label>treatment group 3-Ⅱ</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>low dose GR1603 monthly</description>
    </arm_group>
    <arm_group>
      <arm_group_label>treatment group 4-Ⅱ</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>high dose GR1603 monthly</description>
    </arm_group>
    <arm_group>
      <arm_group_label>treatment group 5-Ⅱ</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>placebo</description>
    </arm_group>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>low dose GR1603 in phase Ⅰb</intervention_name>
      <description>6 subjects in GR1603 low dose，2 subjects in placebo</description>
      <arm_group_label>Treatment group 1-Ⅰb</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>high dose GR1603 in phaseⅠb</intervention_name>
      <description>6 subjects in GR1603 high dose，2 subjects in placebo</description>
      <arm_group_label>Treatment group 2-Ⅰb</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>low dose GR1603 in phase Ⅱ</intervention_name>
      <description>low dose GR1603 monthly</description>
      <arm_group_label>treatment group 3-Ⅱ</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>high dose GR1603 in phase Ⅱ</intervention_name>
      <description>high dose GR1603 monthly</description>
      <arm_group_label>treatment group 4-Ⅱ</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>Placebo in phase Ⅱ</intervention_name>
      <description>Placebo</description>
      <arm_group_label>treatment group 5-Ⅱ</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Diagnosis of SLE according to the ACR 1997 ≥24 weeks&#xD;
  &#xD;
            -  Active moderate to severe SLE&#xD;
  &#xD;
            -  At least one of these antibodies positive: ANA, anti-dsDNA and anti-Smith.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Active severe or unstable neuropsychiatric SLE&#xD;
  &#xD;
            -  Clinically significant laboratory test&#xD;
  &#xD;
            -  Clinically significant active infection&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>70 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>xiaofeng zeng, PHD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Peking Union Medical College Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>xiaofeng zeng, PHD</last_name>
      <phone>010-69154186</phone>
      <email>xiaofeng.zeng@cstar.org.cn</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>juan huang, MD</last_name>
      <phone>18842664061</phone>
      <email>huangjuan@genrixbio.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Peking union Medical Hosipital</name>
        <address>
          <city>Beijing</city>
          <state>Beijing</state>
          <zip>100730</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>jiali tian, MD</last_name>
        <phone>010-69154186</phone>
        <email>tianjiali@pumch.cn</email>
      </contact>
      <investigator>
        <last_name>xiaofeng zeng, PHD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>June 2023</verification_date>
    <study_first_submitted>June 1, 2023</study_first_submitted>
    <study_first_submitted_qc>August 22, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 29, 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 29, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>IFNR</keyword>
    <keyword>Autoimmune Diseases</keyword>
    <keyword>SLE</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Lupus Erythematosus, Systemic</mesh_term>
    </condition_browse>
    <!-- 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/NCT06015230
  org study id: GR1603-002
  nct id: NCT06015230
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  A Study to Investigate the Tolerability, Safety,Pharmacokinetics and efficacy of GR1603 in
        subjects with Systemic Lupus Erythematosus ； GR1603 injection is a monoclonal antibody
        targeting IFNAR1, which can block IFNAR binding to type I interferons such as IFNα and be
        used to treat systemic lupus erythematosus.
  This is a Phase Ib/Ⅱ,double blind, multiple-dose study to evaluate the pharmacokinetics (PK),
        safety，tolerability and efficacy of intravenously administered GR1603 in participants with
        active SLE despite receiving standard of care .
  
        Phase Ib is a multi-dose escalation phase in which 16 subjects are scheduled to enroll.
  
        A total of 120 subjects were randomly assigned to GR1603 injection low dose group, high dose
        group or placebo group in phase Ⅱ.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  measure: Adverse events(phase Ib)
  time frame: up to week 16
  description: to characterise the safety and tolerability of GR1603,including abnormal vital signs,laboratory tests,electrocardiogram and physical examination
  measure: Number of participants who achieved BICLA response (phase Ⅱ)
  time frame: week 24
  description: BICLA respnse:reduction of all baseline BILAG-2004 A to B/C/D and baseline BILAG-2004 B to C/D, and no BILAG-2004 worsening in other organ systems, as defined by ≥1 new BILAG-2004 A or ≥2 new BILAG-2004 B
  measure: Cmax(phaseⅠb）
  time frame: up to week 16
  description: Pharmacokinetic indices
  measure: AUC0-t(phaseⅠb）
  time frame: up to week 16
  description: Pharmacokinetic indices
  measure: AUC0-∞(phaseⅠb）
  time frame: up to week 16
  description: Pharmacokinetic indices
  measure: AUCss(phaseⅠb）
  time frame: up to week 16
  description: Pharmacokinetic indices
  measure: Tmax(phaseⅠb）
  time frame: up to week 16
  description: Pharmacokinetic indices
  measure: t1/2z(phaseⅠb）
  time frame: up to week 16
  description: Pharmacokinetic indices
  measure: Vz(phaseⅠb）
  time frame: up to week 16
  description: Pharmacokinetic indices
  measure: CLz(phaseⅠb）
  time frame: up to week 16
  description: Pharmacokinetic indices
  measure: Number of participants who achieved SRI (4)(phase Ⅱ)
  time frame: up to week 28
  description: An SRI (4) responder defined as a participant who had a reduction in baseline Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score of greater than or equal to 4 points;
  measure: Number of participants who achieved BICLA response(phase Ⅱ)
  time frame: up to week 28
  description: BICLA respnse:reduction of all baseline BILAG-2004 A to B/C/D and baseline BILAG-2004 B to C/D, and no BILAG-2004 worsening in other organ systems, as defined by ≥1 new BILAG-2004 A or ≥2 new BILAG-2004 B
  measure: Number of participants with a ≥50% reduction in CLASI activity score (phase Ⅱ)
  time frame: up to week 28
  description: CLASI:Cutaneous Lupus Erythematosus Disease Area and Severity Index
  measure: Flare rate(phase Ⅱ）
  time frame: up to week 28
  description: A flare was defined as either 1 or more new BILAG-2004 A or 2 or more new BILAG-2004 B items compared to the previous visit
  arm group label: Treatment group 1-Ⅰb
  arm group type: Experimental
  description: 6 subjects in GR1603 low dose，2 subjects in placebo
  arm group label: Treatment group 2-Ⅰb
  arm group type: Experimental
  description: 6 subjects in GR1603 high dose，2 subjects in placebo
  arm group label: treatment group 3-Ⅱ
  arm group type: Experimental
  description: low dose GR1603 monthly
  arm group label: treatment group 4-Ⅱ
  arm group type: Experimental
  description: high dose GR1603 monthly
  arm group label: treatment group 5-Ⅱ
  arm group type: Placebo Comparator
  description: placebo
  intervention type: Biological
  intervention name: low dose GR1603 in phase Ⅰb
  description: 6 subjects in GR1603 low dose，2 subjects in placebo
  arm group label: Treatment group 1-Ⅰb
  intervention type: Biological
  intervention name: high dose GR1603 in phaseⅠb
  description: 6 subjects in GR1603 high dose，2 subjects in placebo
  arm group label: Treatment group 2-Ⅰb
  intervention type: Biological
  intervention name: low dose GR1603 in phase Ⅱ
  description: low dose GR1603 monthly
  arm group label: treatment group 3-Ⅱ
  intervention type: Biological
  intervention name: high dose GR1603 in phase Ⅱ
  description: high dose GR1603 monthly
  arm group label: treatment group 4-Ⅱ
  intervention type: Biological
  intervention name: Placebo in phase Ⅱ
  description: Placebo
  arm group label: treatment group 5-Ⅱ
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 70 Years
  healthy volunteers: No
  last name: xiaofeng zeng, PHD
  role: Principal Investigator
  affiliation: Peking Union Medical College Hospital
  last name: xiaofeng zeng, PHD
  phone: 010-69154186
  email: xiaofeng.zeng@cstar.org.cn
  last name: juan huang, MD
  phone: 18842664061
  email: huangjuan@genrixbio.com
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  country: China
  responsible party type: Sponsor
  mesh term: Lupus Erythematosus, Systemic