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/NCT05970978</url>
    </required_header>
    <id_info>
      <org_study_id>CIBI112A202CN</org_study_id>
      <nct_id>NCT05970978</nct_id>
    </id_info>
    <brief_title>A Study of IBI112 in Chinese Patients With Psoriasis Who Were Previously Treated With Biogolics</brief_title>
    <official_title>A Multicenter, Open-label Study to Evaluate the Efficacy and Safety of IBI112 in Participants With Psoriasis Who Were Treated With Biologics and Switched to IBI112</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Innovent Biologics (Suzhou) Co. Ltd.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Innovent Biologics (Suzhou) 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>
        This is a multicenter, open-label study aim to evaluate the efficacy and safety of IBI112 in&#xD;
        Chinese participants with plaque psoriasis who were treated with biologics and switched to&#xD;
        IBI112. The study will enroll 160 participants who were diagnosed with plaque psariasis. The&#xD;
        whole study consists of 4 weeks of screening, 32 or 36 weeks of treatment and a safety&#xD;
        follow-up visit at Week 44.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 31, 2023</start_date>
    <completion_date type="Anticipated">February 28, 2025</completion_date>
    <primary_completion_date type="Anticipated">September 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>Non-Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Percentage of participants who achieve sPGA clean (0) or nearly clean (1) at week 16.</measure>
      <time_frame>Week 16</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Percentage of participants who achieve sPGA clean (0) at Week 16.</measure>
      <time_frame>Week 16</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Percentage of participants with a DLQI score of 0/1 at Week 16.</measure>
      <time_frame>Week 16</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Percentage of participants with sPGA 0/1 or sPGA 0 or DLQI 0/1 at Week 44.</measure>
      <time_frame>Week 44</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Percentage of participants who achieve sPGA 0 or 1 at week 16 and maintain that up to Week 44</measure>
      <time_frame>Week 16 up to Week 44</time_frame>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">160</enrollment>
    <condition>Psoriasis</condition>
    <arm_group>
      <arm_group_label>Response to previous biologic therapy</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants with sPGA0 or 1 score and the body surface area affected with psoriasis lesions &lt;3% at baseline; or PASI-75 was achieved after treated with the previous biologics. 200mg of IBI112 will be administered subcutaneously at week 0, 12, 24 and 36.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Poor response to previous biologic therapy</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants with sPGA score ≥2 at baseline, or body surface area affected with psoriasis lesions ≥3% at baseline, o PASI-75 was not reached after treated with previous biologics. 200mg of IBI112 will be administered subcutaneously at week 0, 4, 8, 20 and 32.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>regular treatment</intervention_name>
      <description>IBI112 200mg s.c. at week 0, 12, 24 and 36.</description>
      <arm_group_label>Response to previous biologic therapy</arm_group_label>
      <other_name>Response to previous biologic therapy</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Intensive treatment</intervention_name>
      <description>IBI112 200mg s.c. at week 0, 4, 8, 20 and 32.</description>
      <arm_group_label>Poor response to previous biologic therapy</arm_group_label>
      <other_name>Poor response to previous biologic therapy</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. 18 to 75 years old;&#xD;
  &#xD;
            2. Evaluated suitable for continuing biologic therapy for plaque psoriasis by the&#xD;
               investigator;&#xD;
  &#xD;
            3. Received privious biologic therapy with at least 4 months.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Previously or currently diagnosed with pustular psoriasis, erythrodermic psoriasis, or&#xD;
               drug-induced psoriasis (e.g., psoriasis caused by beta blockers, calcium channel&#xD;
               inhibitors, etc.); Or presenting with guttate psoriasis at screening or first dose&#xD;
               administration;&#xD;
  &#xD;
            2. Previously treated with IBI112 or other IL-23 inhibitors;&#xD;
  &#xD;
            3. Treated with two biologics for psoriasis within 4 months prior to screening;&#xD;
  &#xD;
            4. Treated with topical therapy for psoriasis within 2 weeks prior to the first dose&#xD;
               administration, or treated with systemic non-biological agents or phototherapy within&#xD;
               4 weeks prior to the first dose administration;&#xD;
  &#xD;
            5. Treated with Natalizumab, or B/T cell regulators (e.g., Rituximab, Abatacept, or&#xD;
               Visilizumab) within 12 months prior to the first dose administration;&#xD;
  &#xD;
            6. Not willing to avoid constant sunshine and other ultraviolet light sources exposure&#xD;
               during the study;&#xD;
  &#xD;
            7. Treated with an investigational biologic within 6 months prior to the first dose&#xD;
               administration, or any investigational therapy within 30 days, or an investigational&#xD;
               drug within 5 half-lives, or currently participating in a clinical study.&#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>Furen Zhang</last_name>
      <phone>13608921718</phone>
      <email>ZhangFuRenlcsy@163.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Dermatology Hospital of Shandong First Medical University (Shandong Provincial Hospitial of Dermatology)</name>
        <address>
          <city>Jinan</city>
          <state>Shandong</state>
          <zip>250000</zip>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Furen Zhang</last_name>
        <phone>13608921718</phone>
        <email>ZhangFuRenlcsy@163.com</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 24, 2023</study_first_submitted>
    <study_first_submitted_qc>July 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 2, 2023</study_first_posted>
    <last_update_submitted>July 24, 2023</last_update_submitted>
    <last_update_submitted_qc>July 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 2, 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>Psoriasis</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/NCT05970978
  org study id: CIBI112A202CN
  nct id: NCT05970978
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This is a multicenter, open-label study aim to evaluate the efficacy and safety of IBI112 in
        Chinese participants with plaque psoriasis who were treated with biologics and switched to
        IBI112. The study will enroll 160 participants who were diagnosed with plaque psariasis. The
        whole study consists of 4 weeks of screening, 32 or 36 weeks of treatment and a safety
        follow-up visit at Week 44.
  allocation: Non-Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Percentage of participants who achieve sPGA clean (0) or nearly clean (1) at week 16.
  time frame: Week 16
  measure: Percentage of participants who achieve sPGA clean (0) at Week 16.
  time frame: Week 16
  measure: Percentage of participants with a DLQI score of 0/1 at Week 16.
  time frame: Week 16
  measure: Percentage of participants with sPGA 0/1 or sPGA 0 or DLQI 0/1 at Week 44.
  time frame: Week 44
  measure: Percentage of participants who achieve sPGA 0 or 1 at week 16 and maintain that up to Week 44
  time frame: Week 16 up to Week 44
  arm group label: Response to previous biologic therapy
  arm group type: Experimental
  description: Participants with sPGA0 or 1 score and the body surface area affected with psoriasis lesions <3% at baseline; or PASI-75 was achieved after treated with the previous biologics. 200mg of IBI112 will be administered subcutaneously at week 0, 12, 24 and 36.
  arm group label: Poor response to previous biologic therapy
  arm group type: Experimental
  description: Participants with sPGA score ≥2 at baseline, or body surface area affected with psoriasis lesions ≥3% at baseline, o PASI-75 was not reached after treated with previous biologics. 200mg of IBI112 will be administered subcutaneously at week 0, 4, 8, 20 and 32.
  intervention type: Drug
  intervention name: regular treatment
  description: IBI112 200mg s.c. at week 0, 12, 24 and 36.
  arm group label: Response to previous biologic therapy
  other name: Response to previous biologic therapy
  intervention type: Drug
  intervention name: Intensive treatment
  description: IBI112 200mg s.c. at week 0, 4, 8, 20 and 32.
  arm group label: Poor response to previous biologic therapy
  other name: Poor response to previous biologic therapy
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: No
  last name: Furen Zhang
  phone: 13608921718
  email: ZhangFuRenlcsy@163.com
  facility: 
  contact: 
  country: China
  responsible party type: Sponsor
  mesh term: Psoriasis
  sharing ipd: No