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/NCT05983445</url>
    </required_header>
    <id_info>
      <org_study_id>048-301</org_study_id>
      <nct_id>NCT05983445</nct_id>
    </id_info>
    <brief_title>Safety &amp; Efficacy of Genakumab in Patients With Frequent Flares</brief_title>
    <official_title>Safety &amp; Efficacy of Genakumab in Patients With Frequent Flares</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Changchun GeneScience Pharmaceutical Co., Ltd.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Changchun GeneScience Pharmaceutical Co., Ltd.</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        To evaluate the safety and tolerability of single subcutaneous injection of Genakumab for&#xD;
        Injection in patients with acute gout&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Phase Ib: single arm, open lable, single dose, dose escalation,design. There are 3 dose&#xD;
        groups with 10 participant s in each group.&#xD;
  &#xD;
        Phase II: randomized, double-blind, active control design.There are 2 dose groups of&#xD;
        Genakumab for Injection with 30 participant s in each group and 1 group of Compound&#xD;
        Betamethasone Injection with 30 praticipants.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">January 15, 2023</start_date>
    <completion_date type="Anticipated">July 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">October 24, 2023</primary_completion_date>
    <phase>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>The change in the gout pain intensity in the target joint measured by VAS</measure>
      <time_frame>72 hours post-dose</time_frame>
      <description>The Visual Analog Scale (VAS) is an instrument used to measure a person's subjective quantitative evaluation of an item such as pain intensity. In this study patients scored their pain intensity in the joint most affected at Baseline on a 0-100 mm VAS, ranging from no pain (0mm) to unbearable pain (100mm), at 72 hours post-dose. Scores on the 100 mm linear scale were measured to the nearest millimeter from the left.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Time to first new flare</measure>
      <time_frame>12 weeks</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Patients assessment of gout pain intensity in the target joints measured by VAS(0-100mm)</measure>
      <time_frame>At 6, 12, 24, 48, and 72 hours and 7 days post-dose</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The change in the gout pain intensity in the target joint measured by VAS.</measure>
      <time_frame>At 6, 12, 24, 48, and 72 hours and 7 days post-dose</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The number of patients with at least 1 new gout flare</measure>
      <time_frame>12 weeks, 24 weeks, 48 weeks</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time to at Least a 50% Reduction in Baseline Pain Intensity</measure>
      <time_frame>12 weeks</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Percent Patients Who Took Rescue Medication</measure>
      <time_frame>12 weeks</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time to first flare</measure>
      <time_frame>24 weeks, 48 weeks</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Percentage of Participants With Treatment Emergent Adverse Events (TEAEs)</measure>
      <time_frame>12 weeks, 24weeks, 48weeks</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Immunogenicity The incidence of anti-drug antibodies (ADA) and the incidence of neutralizing antibody</measure>
      <time_frame>24 weeks, 48 weeks</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Genakumab Pharmacokinetics (PK) Serum Concentration During the Treatment Period</measure>
      <time_frame>2 hours pre-dose, Days 4，8，29，57，85，169，253 days post-dose</time_frame>
      <description>Blood was collected for Ganakumab levels at2 hours pre-dose, Days 4，8，29，57，85，169，253 days post-dose.</description>
    </secondary_outcome>
    <other_outcome>
      <measure>High Sensitivity C-reactive Protein (hsCRP)</measure>
      <time_frame>72 hours, 7 days and 4 weeks post-dose</time_frame>
    </other_outcome>
    <other_outcome>
      <measure>SF-36</measure>
      <time_frame>8 weeks, 24 weeks and 48 weeks</time_frame>
      <description>The SF-36 measures the impact of disease on overall quality of life (QoL). This 36-item survey has 8 subscales that can be aggregated into physical- and mental-component summary scores. Scores are standardized with the use of norm-based methods based on an assessment of the general U.S. population free of chronic conditions. Scores range from 1-100 with a mean=50 and a standard deviation=10. A higher score indicates less impact on QoL. A negative change score indicates improvement. An ANCOVA model was used with treatment group and baseline SF-36 physical function subscore as covariates.</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">302</enrollment>
    <condition>Acute Gout</condition>
    <arm_group>
      <arm_group_label>Genakumab</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Genakumab 200mg s.c</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Diprospan</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Diprospan 7mg im</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>genakumab</intervention_name>
      <description>200mg s.c.</description>
      <arm_group_label>Genakumab</arm_group_label>
      <other_name>• Gensci048</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>placebo for Diprospan</intervention_name>
      <description>i.m.</description>
      <arm_group_label>Genakumab</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>placebo for genakumab</intervention_name>
      <description>s.c.</description>
      <arm_group_label>Diprospan</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Diprospan</intervention_name>
      <description>7mg i.m.</description>
      <arm_group_label>Diprospan</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Male or female, 18 years ≤ age ≤75 years&#xD;
  &#xD;
            -  BMI≤40kg/m2&#xD;
  &#xD;
            -  Meeting ACR 2015 preliminary criteria for the classification of acute arthritis of&#xD;
               primary gout.&#xD;
  &#xD;
            -  Start of acute gout flare within 4 days prior to enrolled&#xD;
  &#xD;
            -  History of ≥ 2 gout flares within the 12 months prior to study start&#xD;
  &#xD;
            -  Evidence of contraindication (absolute or relative), or intolerance, or lack of&#xD;
               efficacy for either NSAIDs and/or colchicines&#xD;
  &#xD;
            -  Baseline pain intensity ≥ 50 mm on the 0-100 mm visual analog scale (VAS)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          -&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Ting Liu</last_name>
      <phone>18946532759</phone>
      <email>liuting01@gensci-china.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Fudan University Affiliated Huashan Hospital</name>
        <address>
          <city>Shanghai</city>
          <state>Shanghai</state>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Hejian Zou</last_name>
        <phone>021-52888045</phone>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>December 2022</verification_date>
    <study_first_submitted>December 20, 2022</study_first_submitted>
    <study_first_submitted_qc>August 6, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 9, 2023</study_first_posted>
    <last_update_submitted>August 6, 2023</last_update_submitted>
    <last_update_submitted_qc>August 6, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 9, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>acute gout</keyword>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Betamethasone dipropionate, betamethasone sodium phosphate drug combination</mesh_term>
      <mesh_term>Betamethasone</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>Undecided</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/NCT05983445
  org study id: 048-301
  nct id: NCT05983445
  lead sponsor: 
  has dmc: No
  is fda regulated drug: Yes
  is fda regulated device: No
  To evaluate the safety and tolerability of single subcutaneous injection of Genakumab for
        Injection in patients with acute gout
  Phase Ib: single arm, open lable, single dose, dose escalation,design. There are 3 dose
        groups with 10 participant s in each group.
  
        Phase II: randomized, double-blind, active control design.There are 2 dose groups of
        Genakumab for Injection with 30 participant s in each group and 1 group of Compound
        Betamethasone Injection with 30 praticipants.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  measure: The change in the gout pain intensity in the target joint measured by VAS
  time frame: 72 hours post-dose
  description: The Visual Analog Scale (VAS) is an instrument used to measure a person's subjective quantitative evaluation of an item such as pain intensity. In this study patients scored their pain intensity in the joint most affected at Baseline on a 0-100 mm VAS, ranging from no pain (0mm) to unbearable pain (100mm), at 72 hours post-dose. Scores on the 100 mm linear scale were measured to the nearest millimeter from the left.
  measure: Time to first new flare
  time frame: 12 weeks
  measure: Patients assessment of gout pain intensity in the target joints measured by VAS(0-100mm)
  time frame: At 6, 12, 24, 48, and 72 hours and 7 days post-dose
  measure: The change in the gout pain intensity in the target joint measured by VAS.
  time frame: At 6, 12, 24, 48, and 72 hours and 7 days post-dose
  measure: The number of patients with at least 1 new gout flare
  time frame: 12 weeks, 24 weeks, 48 weeks
  measure: Time to at Least a 50% Reduction in Baseline Pain Intensity
  time frame: 12 weeks
  measure: Percent Patients Who Took Rescue Medication
  time frame: 12 weeks
  measure: Time to first flare
  time frame: 24 weeks, 48 weeks
  measure: Percentage of Participants With Treatment Emergent Adverse Events (TEAEs)
  time frame: 12 weeks, 24weeks, 48weeks
  measure: Immunogenicity The incidence of anti-drug antibodies (ADA) and the incidence of neutralizing antibody
  time frame: 24 weeks, 48 weeks
  measure: Genakumab Pharmacokinetics (PK) Serum Concentration During the Treatment Period
  time frame: 2 hours pre-dose, Days 4，8，29，57，85，169，253 days post-dose
  description: Blood was collected for Ganakumab levels at2 hours pre-dose, Days 4，8，29，57，85，169，253 days post-dose.
  measure: High Sensitivity C-reactive Protein (hsCRP)
  time frame: 72 hours, 7 days and 4 weeks post-dose
  measure: SF-36
  time frame: 8 weeks, 24 weeks and 48 weeks
  description: The SF-36 measures the impact of disease on overall quality of life (QoL). This 36-item survey has 8 subscales that can be aggregated into physical- and mental-component summary scores. Scores are standardized with the use of norm-based methods based on an assessment of the general U.S. population free of chronic conditions. Scores range from 1-100 with a mean=50 and a standard deviation=10. A higher score indicates less impact on QoL. A negative change score indicates improvement. An ANCOVA model was used with treatment group and baseline SF-36 physical function subscore as covariates.
  arm group label: Genakumab
  arm group type: Experimental
  description: Genakumab 200mg s.c
  arm group label: Diprospan
  arm group type: Active Comparator
  description: Diprospan 7mg im
  intervention type: Drug
  intervention name: genakumab
  description: 200mg s.c.
  arm group label: Genakumab
  other name: • Gensci048
  intervention type: Drug
  intervention name: placebo for Diprospan
  description: i.m.
  arm group label: Genakumab
  intervention type: Drug
  intervention name: placebo for genakumab
  description: s.c.
  arm group label: Diprospan
  intervention type: Drug
  intervention name: Diprospan
  description: 7mg i.m.
  arm group label: Diprospan
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: No
  last name: Ting Liu
  phone: 18946532759
  email: liuting01@gensci-china.com
  facility: 
  status: Recruiting
  contact: 
  country: China
  responsible party type: Sponsor
  mesh term: Betamethasone dipropionate, betamethasone sodium phosphate drug combination
  mesh term: Betamethasone
  sharing ipd: Undecided