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/NCT06015243</url>
    </required_header>
    <id_info>
      <org_study_id>GR1802-010</org_study_id>
      <nct_id>NCT06015243</nct_id>
    </id_info>
    <brief_title>The Study of Long-term Outcomes of GR1802 in Patients With Chronic Rhinosinusitis With Nasal Polyps</brief_title>
    <official_title>An Open-label, Single-arm, Multicenter, Extension Study to Evaluate the Long-term Safety and Efficacy of GR1802 Injection in Patients With Chronic Rhinosinusitis With Nasal Polyps</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>
        This is an open-label, single-arm, multicenter, extension study to evaluate the long-term&#xD;
        safety and efficacy of GR1802 injection in patients with Chronic Rhinosinusitis With Nasal&#xD;
        Polyps&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This trial was designed as an open, extension trial with the primary objective of evaluating&#xD;
        the safety of long-term administration of GR1802 injection in patients with chronic&#xD;
        rhinosinusitis with nasal polyps, and to a lesser extent, also evaluating the efficacy,&#xD;
        immunogenicity, etc.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 18, 2023</start_date>
    <completion_date type="Anticipated">March 30, 2025</completion_date>
    <primary_completion_date type="Anticipated">December 30, 2024</primary_completion_date>
    <phase>Phase 2</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Adverse events</measure>
      <time_frame>Baseline up to Week 24</time_frame>
      <description>to characterise the safety and tolerability of GR1802 injection, including abnormal vital signs, laboratory tests, electrocardiogram.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change From Baseline at each evaluation time point in Nasal Polyp Score</measure>
      <time_frame>Baseline up to Week 24</time_frame>
      <description>NPS score ranges from 0-8. (sum of 0-4 for each nasal passage scores), higher score means a worse outcome.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change From Baseline at each evaluation time in Nasal Congestion/Obstruction Symptom(NCS) Severity Score</measure>
      <time_frame>Baseline up to Week 24</time_frame>
      <description>Change from baseline in the NCS score. NCS score (0-3), higher score means worse nasal symptom.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Total Nasal Symptom Score(TNSS) score</measure>
      <time_frame>Baseline up to Week 24</time_frame>
      <description>Change from baseline in TNSS score. TNSS score (0-9). Higher score means worse nasal symptom.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>University of Pennsylvania Smell Identification Test (UPSIT)</measure>
      <time_frame>Baseline up to Week 24</time_frame>
      <description>Change from baseline in UPSIT. UPSIT score (0-40). Higher score means better sense of smell.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Visual Analogue Scale (VAS) for Rhinosinusitis</measure>
      <time_frame>Baseline up to Week 24</time_frame>
      <description>Change from baseline in VAS score. VAS score (0-10). Higher score means worse nasal symptom.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportion of subjects receiving rescue therapy for nasal polyps</measure>
      <time_frame>Baseline up to Week 24</time_frame>
      <description>Rescue therapy includes Systemic Corticosteroids and endoscopic surgery</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Ctrough</measure>
      <time_frame>Baseline up to Week 24</time_frame>
      <description>PK parameter: trough concentration of GR1802 injection. and exposure（CL/F, Vz/F etc.）</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Vz/F</measure>
      <time_frame>Baseline up to Week 24</time_frame>
      <description>PK parameter: The volume of distribution based on the terminal elimination phase adjusted by bioavailability.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>CL/F</measure>
      <time_frame>Baseline up to Week 24</time_frame>
      <description>PK parameter: The apparent volume of the central compartment cleared of drug per unit time adjusted by bioavailability.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Anti-drug antibodies(ADA)</measure>
      <time_frame>Baseline up to Week 24</time_frame>
      <description>Incidence of ADA</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">70</enrollment>
    <condition>Chronic Rhinosinusitis With Nasal Polyps</condition>
    <arm_group>
      <arm_group_label>Experimental: GR1802</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>GR1802 injection 300mg every two weeks for 16-week treatment</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>GR1802 injection</intervention_name>
      <description>150mg/1ml. 2 ml every two weeks Route of administration: Subcutaneous</description>
      <arm_group_label>Experimental: GR1802</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Participation in a clinical study of GR1802 injection for the treatment of chronic&#xD;
               rhinosinusitis with nasal polyps (Protocol No. GR1802-005) and fulfillment of the&#xD;
               following: completion of prescribed treatment as required by the protocol and&#xD;
               completion of the W16 visit.&#xD;
  &#xD;
            2. the investigator judges that the subject may benefit from continued use of the test&#xD;
               drug.&#xD;
  &#xD;
            3. Able to understand and comply with the requirements of the clinical protocol,&#xD;
               voluntarily participate in the clinical trial, and sign the informed consent form&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Poor compliance in the GR1802-005 trial and in the judgment of the investigator is&#xD;
               unable to complete this continuation trial;&#xD;
  &#xD;
            2. Use of any protocol-specified prohibited medication/treatment during the GR1802-005&#xD;
               trial and prior to the first dose of this study that, in the judgment of the&#xD;
               investigator, makes continued participation in the continuation trial unsuitable.&#xD;
  &#xD;
            3. The time to first dosing in the extension trial program was greater than 4 weeks from&#xD;
               the GR1802-005 study W16 visit;&#xD;
  &#xD;
            4. Nasal polyp scoring is not available for nasal polyp scores for nasal or sinus surgery&#xD;
               (e.g., nasal polypectomy, balloon dilatation, or intranasal stent placement) that was&#xD;
               performed prior to the first administration of the drug in the extension trial that&#xD;
               alters the structure of the nasal sidewall;&#xD;
  &#xD;
            5. Individuals who have received live/attenuated vaccination within 8 weeks prior to the&#xD;
               first dose of the extension trial or who plan to receive live/attenuated vaccination&#xD;
               during the trial;&#xD;
  &#xD;
            6. Any serious progressive or poorly controlled concomitant disease (e.g., asthma&#xD;
               exacerbation requiring adjustment of background medication) identified during the&#xD;
               GR1802-005 study period for which, in the judgment of the Principal Investigator, the&#xD;
               subject is considered unsuitable for participation in the trial;&#xD;
  &#xD;
            7. Other.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 15, 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>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Sinusitis</mesh_term>
      <mesh_term>Nasal Polyps</mesh_term>
      <mesh_term>Polyps</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/NCT06015243
  org study id: GR1802-010
  nct id: NCT06015243
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  This is an open-label, single-arm, multicenter, extension study to evaluate the long-term
        safety and efficacy of GR1802 injection in patients with Chronic Rhinosinusitis With Nasal
        Polyps
  This trial was designed as an open, extension trial with the primary objective of evaluating
        the safety of long-term administration of GR1802 injection in patients with chronic
        rhinosinusitis with nasal polyps, and to a lesser extent, also evaluating the efficacy,
        immunogenicity, etc.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Adverse events
  time frame: Baseline up to Week 24
  description: to characterise the safety and tolerability of GR1802 injection, including abnormal vital signs, laboratory tests, electrocardiogram.
  measure: Change From Baseline at each evaluation time point in Nasal Polyp Score
  time frame: Baseline up to Week 24
  description: NPS score ranges from 0-8. (sum of 0-4 for each nasal passage scores), higher score means a worse outcome.
  measure: Change From Baseline at each evaluation time in Nasal Congestion/Obstruction Symptom(NCS) Severity Score
  time frame: Baseline up to Week 24
  description: Change from baseline in the NCS score. NCS score (0-3), higher score means worse nasal symptom.
  measure: Total Nasal Symptom Score(TNSS) score
  time frame: Baseline up to Week 24
  description: Change from baseline in TNSS score. TNSS score (0-9). Higher score means worse nasal symptom.
  measure: University of Pennsylvania Smell Identification Test (UPSIT)
  time frame: Baseline up to Week 24
  description: Change from baseline in UPSIT. UPSIT score (0-40). Higher score means better sense of smell.
  measure: Visual Analogue Scale (VAS) for Rhinosinusitis
  time frame: Baseline up to Week 24
  description: Change from baseline in VAS score. VAS score (0-10). Higher score means worse nasal symptom.
  measure: Proportion of subjects receiving rescue therapy for nasal polyps
  time frame: Baseline up to Week 24
  description: Rescue therapy includes Systemic Corticosteroids and endoscopic surgery
  measure: Ctrough
  time frame: Baseline up to Week 24
  description: PK parameter: trough concentration of GR1802 injection. and exposure（CL/F, Vz/F etc.）
  measure: Vz/F
  time frame: Baseline up to Week 24
  description: PK parameter: The volume of distribution based on the terminal elimination phase adjusted by bioavailability.
  measure: CL/F
  time frame: Baseline up to Week 24
  description: PK parameter: The apparent volume of the central compartment cleared of drug per unit time adjusted by bioavailability.
  measure: Anti-drug antibodies(ADA)
  time frame: Baseline up to Week 24
  description: Incidence of ADA
  arm group label: Experimental: GR1802
  arm group type: Experimental
  description: GR1802 injection 300mg every two weeks for 16-week treatment
  intervention type: Drug
  intervention name: GR1802 injection
  description: 150mg/1ml. 2 ml every two weeks Route of administration: Subcutaneous
  arm group label: Experimental: GR1802
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  responsible party type: Sponsor
  mesh term: Sinusitis
  mesh term: Nasal Polyps
  mesh term: Polyps
  sharing ipd: No