<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/NCT04428255</url>
  </required_header>
  <id_info>
    <org_study_id>9161.4</org_study_id>
    <nct_id>NCT04428255</nct_id>
  </id_info>
  <brief_title>A Clinical Study on the Efficacy and Safety of HBM9161 in Patients With ITP</brief_title>
  <official_title>A Randomized, Double-blind, Placebo-controlled, Phase 2/3 Operational Seamless Designed Clinical Study to Evaluate the Efficacy and Safety of HBM9161 Weekly Subcutaneous Injection in Patients With Primary Immune Thrombocytopenia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Harbour BioMed (Guangzhou) Co. Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Harbour BioMed (Guangzhou) 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>
      To select a dose and to make a decision for Phase 3 study&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The onset of primary immune thrombocytopenia is thought to be increased platelet destruction&#xD;
      and decreased platelet production due to anti-platelet antibodies. HBM9161 is a fully human&#xD;
      anti-FcRn monoclonal antibody that can effectively remove pathogenic IgG, thereby relieving&#xD;
      platelet destruction and rapidly increasing platelet counts in patients. The study will be&#xD;
      conducted in a Phase 2/3 operational seamless design, with group Dose A and Dose B of HBM9161&#xD;
      and a placebo group in Phase 2.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 21, 2020</start_date>
  <completion_date type="Anticipated">March 11, 2023</completion_date>
  <primary_completion_date type="Anticipated">July 17, 2021</primary_completion_date>
  <phase>Phase 2/Phase 3</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>Proportion of patients who achieve the early response.</measure>
    <time_frame>7 weeks</time_frame>
    <description>The primary endpoint of phase 2</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients who achieve platelet count ≥ 50 × 10^9/L at least 2 times within 7 weeks.</measure>
    <time_frame>7 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">36</enrollment>
  <condition>Primary Immune Thrombocytopenic Purpura</condition>
  <arm_group>
    <arm_group_label>HBM9161 Dose A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will be randomized in a 1:1:1 ratio to HBM9161 (Dose A or Dose B) or placebo</description>
  </arm_group>
  <arm_group>
    <arm_group_label>HBM9161 Dose B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will be randomized in a 1:1:1 ratio to HBM9161 (Dose A or Dose B) or placebo</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Patients will be randomized in a 1:1:1 ratio to HBM9161 (Dose A or Dose B) or placebo</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>HBM9161 Dose A</intervention_name>
    <description>HBM9161 (Dose A or Dose B) or matching placebo will be administered IV weekly</description>
    <arm_group_label>HBM9161 Dose A</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>HBM9161 Dose B</intervention_name>
    <description>HBM9161 (Dose A or Dose B) or matching placebo will be administered IV weekly</description>
    <arm_group_label>HBM9161 Dose B</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>HBM9161 (Dose A or Dose B) or matching placebo will be administered IV weekly</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. ≥ 18 years of age at the screening visit, male or female.&#xD;
&#xD;
          2. Persistent or chronic ITP whose average number of platelet at the screening visit and&#xD;
             pre-dose (at least 1 day apart) is &lt; 30 × 10^9/L, and not &gt; 35 × 10^9/L for any of two&#xD;
             tests. No severe bleeding within 4 weeks prior to the screening visit.&#xD;
&#xD;
          3. Patients who have received and failed at least 1 first line of ITP therapy&#xD;
             (glucocorticoids and/or intravenous gamma globulin), or who are contraindicated,&#xD;
             intolerable, or refuse standard therapy.&#xD;
&#xD;
          4. Patients will be allowed to use a stable dose of concomitant drugs for the treatment&#xD;
             of ITP. e.g., glucocorticoid, danazol, immunosuppressant (azathioprine, cyclosporine&#xD;
             A, mycophenolate mofetil) and eltrombopag.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Other autoimmune systemic diseases other than ITP.&#xD;
&#xD;
          2. Multi-lineage immune cytopenias, such as Evan's syndrome, autoimmune pancytopenia.&#xD;
&#xD;
          3. Secondary ITP.&#xD;
&#xD;
          4. Received a vaccine within 4 weeks prior to the first dose of the study drug or planned&#xD;
             during the study.&#xD;
&#xD;
          5. Use of anticoagulants or any agents that have antiplatelet effect or can affect&#xD;
             thrombopoiesis within 3 weeks prior to the first dose of the study drug.&#xD;
&#xD;
          6. Received blood transfusion within 1 week prior to the first dose of the study drug.&#xD;
&#xD;
          7. Received the intravenous gamma globulin, anti-D immunoglobulin, or plasmapheresis&#xD;
             within 2 weeks prior to the first dose of the study drug.&#xD;
&#xD;
          8. Received high-dose dexamethasone or high-dose methylprednisolone within 2 weeks prior&#xD;
             to the first dose of the study drug.&#xD;
&#xD;
          9. Received recombinant human thrombopoietin (rhTPO) within 4 weeks prior to the first&#xD;
             does of the study drug.&#xD;
&#xD;
         10. Received rituximab or other non-rituximab anti-CD20 drugs within 6 months prior to the&#xD;
             first does of the study drug.&#xD;
&#xD;
         11. Treated with splenectomy within 4 weeks prior to first dose of the study drug.&#xD;
&#xD;
         12. Any thromboembolic or embolic events within 12 months prior to the first does of the&#xD;
             study drug.&#xD;
&#xD;
         13. Serum total IgG &lt; 700 mg/dL at the screening visit.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Renchi Yang</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hematology hospital, Chinese academy of medical sciences</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Shuai Zhao</last_name>
    <phone>+86 15901236575</phone>
    <email>peter.zhao@harbourbiomed.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Hematology hospital, Chinese academy of medical sciences</name>
      <address>
        <city>Tianjin</city>
        <state>Tianjin</state>
        <zip>300020</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Renchi Yang, doctor</last_name>
      <phone>+86 13512078851</phone>
      <email>rcyang65@163.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>June 9, 2020</study_first_submitted>
  <study_first_submitted_qc>June 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>February 9, 2021</last_update_submitted>
  <last_update_submitted_qc>February 9, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 10, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>ITP</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Purpura</mesh_term>
    <mesh_term>Purpura, Thrombocytopenic</mesh_term>
    <mesh_term>Purpura, Thrombocytopenic, Idiopathic</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>March 27, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/55/NCT04428255/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT04428255
org study id: 9161.4
nct id: NCT04428255
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
To select a dose and to make a decision for Phase 3 study
The onset of primary immune thrombocytopenia is thought to be increased platelet destruction
      and decreased platelet production due to anti-platelet antibodies. HBM9161 is a fully human
      anti-FcRn monoclonal antibody that can effectively remove pathogenic IgG, thereby relieving
      platelet destruction and rapidly increasing platelet counts in patients. The study will be
      conducted in a Phase 2/3 operational seamless design, with group Dose A and Dose B of HBM9161
      and a placebo group in Phase 2.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Proportion of patients who achieve the early response.
time frame: 7 weeks
description: The primary endpoint of phase 2
measure: Proportion of patients who achieve platelet count ≥ 50 × 10^9/L at least 2 times within 7 weeks.
time frame: 7 weeks
arm group label: HBM9161 Dose A
arm group type: Experimental
description: Patients will be randomized in a 1:1:1 ratio to HBM9161 (Dose A or Dose B) or placebo
arm group label: HBM9161 Dose B
arm group type: Experimental
description: Patients will be randomized in a 1:1:1 ratio to HBM9161 (Dose A or Dose B) or placebo
arm group label: Placebo
arm group type: Placebo Comparator
description: Patients will be randomized in a 1:1:1 ratio to HBM9161 (Dose A or Dose B) or placebo
intervention type: Drug
intervention name: HBM9161 Dose A
description: HBM9161 (Dose A or Dose B) or matching placebo will be administered IV weekly
arm group label: HBM9161 Dose A
intervention type: Drug
intervention name: HBM9161 Dose B
description: HBM9161 (Dose A or Dose B) or matching placebo will be administered IV weekly
arm group label: HBM9161 Dose B
intervention type: Drug
intervention name: Placebo
description: HBM9161 (Dose A or Dose B) or matching placebo will be administered IV weekly
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Renchi Yang
role: Principal Investigator
affiliation: Hematology hospital, Chinese academy of medical sciences
last name: Shuai Zhao
phone: +86 15901236575
email: peter.zhao@harbourbiomed.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor
mesh term: Purpura
mesh term: Purpura, Thrombocytopenic
mesh term: Purpura, Thrombocytopenic, Idiopathic
provided document: 