<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/NCT04457856</url>
  </required_header>
  <id_info>
    <org_study_id>TJ003234RAR102</org_study_id>
    <nct_id>NCT04457856</nct_id>
  </id_info>
  <brief_title>A Study of TJ003234 in Rheumatoid Arthritis Patients</brief_title>
  <official_title>A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single Ascending Dose and Multiple Ascending Doses of TJ003234 in Rheumatoid Arthritis Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>I-Mab Biopharma Co. Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>I-Mab Biopharma Co. Ltd.</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>
      Study Purpose and Design: A Multi-center, Randomized, Double-blind, Placebo-controlled Study&#xD;
      to Evaluate the Safety, Tolerability and Pharmacokinetics of Single Ascending Dose and&#xD;
      Multiple Ascending Doses of TJ003234 in Rheumatoid Arthritis Patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">August 6, 2020</start_date>
  <completion_date type="Anticipated">March 2023</completion_date>
  <primary_completion_date type="Anticipated">March 2023</primary_completion_date>
  <phase>Phase 1</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>
    <intervention_model_description>Randomized, Double-blind, Placebo-controlled</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>Double-blind</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Number of subject with adverse events(AEs)</measure>
    <time_frame>First dose up to last follow-up visit (i.e. 90 days after dosing for single dose part, 140 days after first dose for multiple dose part)</time_frame>
    <description>Number of subject with adverse events(AEs) to evaluate satety in patient with RA with vital signs, Electrocardiograms, physical examinations, laboratory tests and respiratory-related examinations</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>AUC from time 0 to the time of the last quantifiable concentration AUC0-tlast of TJ003234</measure>
    <time_frame>Day1 to 90 days after dosing for single dose part, 140 days after for multiple dose part</time_frame>
    <description>AUC from time 0 to the time of the last quantifiable concentration AUC0-tlast of TJ003234</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum observed plasma concentration (Cmax) of TJ003234</measure>
    <time_frame>Day1 to 90 days after dosing for single dose part, 140 days after for multiple dose part</time_frame>
    <description>Maximum observed plasma concentration (Cmax) of TJ003234</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The proportion of subjects who produce anti-drug antibodies</measure>
    <time_frame>Day1 to 90 days after dosing for single dose part, 140 days after for multiple dose part</time_frame>
    <description>The proportion of subjects who produce anti-drug antibodies</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The proportion of subjects who produce neutralizing antibodies</measure>
    <time_frame>Day1 to 90 days after dosing for single dose part, 140 days after for multiple dose part</time_frame>
    <description>The proportion of subjects who produce neutralizing antibodies</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The proportion of subjects who produce the titers of anti-drug antibodies and neutralizing antibodies</measure>
    <time_frame>Day1 to 90 days after dosing for single dose part, 140 days after for multiple dose part</time_frame>
    <description>The proportion of subjects who produce the titers of anti-drug antibodies and neutralizing antibodies</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">63</enrollment>
  <condition>Rheumatoid Arthritis</condition>
  <arm_group>
    <arm_group_label>TJ003234</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intravenous administration, single dose (0.3-1-3-10mg/kg) or multiple dose (1-3-6mg/kg, once every week, for 8 weeks) Mode of administration: The investigational drug is administered by intravenous infusion</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Intravenous administration, single dose (0.3-1-3-10mg/kg) or multiple dose (1-3-6mg/kg, once every week, for 8 weeks) Mode of administration: The investigational drug is administered by intravenous infusion</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>TJ003234 injection</intervention_name>
    <description>Intravenous administration, single dose (0.3-1-3-10mg/kg) or multiple dose (1-3-6mg/kg, once every week, for 8 weeks)</description>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_label>TJ003234</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects must be ≥ 18 and ≤70 years old when signing the informed consent, with no&#xD;
             limitation of gender.&#xD;
&#xD;
          -  Established Rheumatoid arthritis patients, diagnosed by ACR/EULAR criteria 2010 at&#xD;
             least 6 months prior to randomisation.&#xD;
&#xD;
          -  Single Ascending Dose: DAS28 score≤3.2. Multiple Ascending Dose: DAS28 score≤5.1 and&#xD;
             &gt;3.2.&#xD;
&#xD;
          -  Allowed one or more standard treatments, but the start date should no later than 12&#xD;
             weeks(84 days) before the randomisation and should take at a stable dose more than 4&#xD;
             weeks(28 days) before the randomisation. The combination taken of Methotrexate (MTX)&#xD;
             and leflunomide was not allowed within 4 weeks (28 days) before randomization.&#xD;
&#xD;
          -  Subjects must agree to attendance the study and signed the inform concent by&#xD;
             themselves.&#xD;
&#xD;
          -  Subjects(include subjects's wife) are no pregnancy plan during the sceering and 3&#xD;
             months after complete the study and agree to use contraceptives that protocol suggest.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Employees of the hospital or any other person that paticipant in the study and their&#xD;
             immedidte family members.&#xD;
&#xD;
          -  A documented history of an autoimmune disease other than RA (other than secondary&#xD;
             Sjögren's syndrome) .&#xD;
&#xD;
          -  Previous received Any biologic DMARD therapy including tsDMARD. •A positive hepatitis&#xD;
             B (HBsAg, anti-HBc, and/or IgM anti-HBc), hepatitis C or HIV test at screening,&#xD;
             indicative of a current or past infection.&#xD;
&#xD;
          -  A history of active tuberculosis (TB) or positive serological test for TB (Quantiferon&#xD;
             TB Gold or T-SPOT).&#xD;
&#xD;
          -  Female patients who are pregnant during the study, or are breastfeeding. •Malignancy,&#xD;
             or prior malignancy, with a disease free interval of &lt;5 years after diagnosis and&#xD;
             intervention except curative treatment for basal and squamous cell skin cancer.&#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_contact>
    <last_name>Zhanguo Li</last_name>
    <phone>+86010-88326666</phone>
    <email>li99@bjmu.edu.cn</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>yingchao Zhou</last_name>
    <phone>+86010-56176269</phone>
    <email>yingchao.zhou@i-mabbiopharma.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>The first affiliated hospital of bengbu medical college</name>
      <address>
        <city>Bengbu</city>
        <state>Anhui</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Zhijun Li</last_name>
      <phone>13955289810</phone>
      <email>lizhijundr@126.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Peking university people's Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>10044</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Zhanguo Li</last_name>
      <phone>+86010-88326666</phone>
      <email>li99@bjmu.edu.cn</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Nanjing Drum Tower Hospital</name>
      <address>
        <city>Nanjing</city>
        <state>Jiangsu</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lingyun Sun</last_name>
      <phone>13705186409</phone>
      <email>lingyunsun2012@163.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Zhongda Hospital southeast university</name>
      <address>
        <city>Nanjing</city>
        <state>Jiangsu</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Meimei Wang</last_name>
      <phone>13505167748</phone>
      <email>wmm3272142@163.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>FuDan University shanghai huashan Hospital</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yu Xue</last_name>
      <phone>18918760187</phone>
      <email>18121186087@163.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>June 28, 2020</study_first_submitted>
  <study_first_submitted_qc>June 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>August 2, 2022</last_update_submitted>
  <last_update_submitted_qc>August 2, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 3, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Rheumatoid Arthritis</keyword>
  <keyword>biologics</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Arthritis</mesh_term>
    <mesh_term>Arthritis, Rheumatoid</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Plonmarlimab</mesh_term>
  </intervention_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/NCT04457856
org study id: TJ003234RAR102
nct id: NCT04457856
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Study Purpose and Design: A Multi-center, Randomized, Double-blind, Placebo-controlled Study
      to Evaluate the Safety, Tolerability and Pharmacokinetics of Single Ascending Dose and
      Multiple Ascending Doses of TJ003234 in Rheumatoid Arthritis Patients.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized, Double-blind, Placebo-controlled
primary purpose: Treatment
masking: Single (Participant)
masking description: Double-blind
measure: Number of subject with adverse events(AEs)
time frame: First dose up to last follow-up visit (i.e. 90 days after dosing for single dose part, 140 days after first dose for multiple dose part)
description: Number of subject with adverse events(AEs) to evaluate satety in patient with RA with vital signs, Electrocardiograms, physical examinations, laboratory tests and respiratory-related examinations
measure: AUC from time 0 to the time of the last quantifiable concentration AUC0-tlast of TJ003234
time frame: Day1 to 90 days after dosing for single dose part, 140 days after for multiple dose part
description: AUC from time 0 to the time of the last quantifiable concentration AUC0-tlast of TJ003234
measure: Maximum observed plasma concentration (Cmax) of TJ003234
time frame: Day1 to 90 days after dosing for single dose part, 140 days after for multiple dose part
description: Maximum observed plasma concentration (Cmax) of TJ003234
measure: The proportion of subjects who produce anti-drug antibodies
time frame: Day1 to 90 days after dosing for single dose part, 140 days after for multiple dose part
description: The proportion of subjects who produce anti-drug antibodies
measure: The proportion of subjects who produce neutralizing antibodies
time frame: Day1 to 90 days after dosing for single dose part, 140 days after for multiple dose part
description: The proportion of subjects who produce neutralizing antibodies
measure: The proportion of subjects who produce the titers of anti-drug antibodies and neutralizing antibodies
time frame: Day1 to 90 days after dosing for single dose part, 140 days after for multiple dose part
description: The proportion of subjects who produce the titers of anti-drug antibodies and neutralizing antibodies
arm group label: TJ003234
arm group type: Experimental
description: Intravenous administration, single dose (0.3-1-3-10mg/kg) or multiple dose (1-3-6mg/kg, once every week, for 8 weeks) Mode of administration: The investigational drug is administered by intravenous infusion
arm group label: Placebo
arm group type: Placebo Comparator
description: Intravenous administration, single dose (0.3-1-3-10mg/kg) or multiple dose (1-3-6mg/kg, once every week, for 8 weeks) Mode of administration: The investigational drug is administered by intravenous infusion
intervention type: Biological
intervention name: TJ003234 injection
description: Intravenous administration, single dose (0.3-1-3-10mg/kg) or multiple dose (1-3-6mg/kg, once every week, for 8 weeks)
arm group label: Placebo
arm group label: TJ003234
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Zhanguo Li
phone: +86010-88326666
email: li99@bjmu.edu.cn
last name: yingchao Zhou
phone: +86010-56176269
email: yingchao.zhou@i-mabbiopharma.com
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor
mesh term: Arthritis
mesh term: Arthritis, Rheumatoid
mesh term: Plonmarlimab
sharing ipd: No