<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/NCT04414605</url>
  </required_header>
  <id_info>
    <org_study_id>BF2020-068-02</org_study_id>
    <nct_id>NCT04414605</nct_id>
  </id_info>
  <brief_title>Oral Chinese Herbal Medicine Concurrent With Secukinumab for Severe Plaque Psoriasis</brief_title>
  <official_title>Oral Chinese Herbal Medicine Formula (Gu Ben Hua Yu Fang) Concurrent With Secukinumab for Severe Plaque Psoriasis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Guangdong Provincial Hospital of Traditional Chinese Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Guangdong Provincial Hospital of Traditional Chinese Medicine</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>
      The aim of this study is to determine whether oral Chinese herbal medicine in combination&#xD;
      secukinumab is effective and safe in the treatment of severe psoriasis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The aim of this study is to determine whether oral Chinese herbal medicine in combination&#xD;
      with secukinumab is effective and safe in the treatment of severe psoriasis. Eligible&#xD;
      participants will be treated with oral Chinese herbal medicine and secukinumab concurrently.&#xD;
      No controlled group will be set up in this trial. The primary outcome is time to relapse.&#xD;
      Secondary outcomes include Psoriasis Area and Severity Index (PASI) 75/90, PASI score&#xD;
      reduction rate, physician's global assessment (PGA) score, body surface area (BSA) score,&#xD;
      visual analogue scale (VAS) score, dermatology life quality index (QLQI) and Skindex 16.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 4, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2021</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2021</primary_completion_date>
  <phase>Early Phase 1</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>Median time to relapse</measure>
    <time_frame>Through study completion, an average of 1 year</time_frame>
    <description>Median time to relapse is a time interval. The time interval will be recorded between the end of treatment and the occurrence of relapse. Relapse was defined as loss of &gt; 50% of maximum Psoriasis Area and Severity Index (PASI) improvement compared with pretreatment baseline.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Psoriasis Area and Severity Index (PASI) score</measure>
    <time_frame>Assessment will be conducted at week 0, 1, 2, 3, 4, and every four weeks throughout the remaining period the this trial, an average of 1 year</time_frame>
    <description>The improvement in Psoriasis Area and Severity Index (PASI) score from baseline after treatment; the scale scores ranged from 0-72. The higher the scores are, the more severe the patients suffer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PASI-75</measure>
    <time_frame>16 weeks after treatment</time_frame>
    <description>The proportion of patients who achieve at least 75% improvement in PASI score from baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PASI-90</measure>
    <time_frame>16 weeks after treatment</time_frame>
    <description>The proportion of patients who achieve at least 90% improvement in PASI score from baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physician's global assessment (PGA) score</measure>
    <time_frame>Assessment will be conducted on week 0, 1, 2, 3, 4, and every four weeks throughout the remaining period the this trial, an average of 1 year.</time_frame>
    <description>Physician's global assessment for the condition</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pruritus Scores on the Visual Analogue Scale</measure>
    <time_frame>Assessment will be conducted on week 0, 1, 2, 3, 4, and every four weeks throughout the remaining period the this trial, an average of 1 year.</time_frame>
    <description>Pruritus will be assessed using the Visual Analogue Scales; The Scale scores ranged from 0-10; the higher the scores are, the more itching the patients suffer.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>BSA</measure>
    <time_frame>Assessment will be conducted on week 0, 1, 2, 3, 4, and every four weeks throughout the remaining period the this trial, an average of 1 year.</time_frame>
    <description>the Body Surface Area</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dermatology Life Quality Index (DLQI)</measure>
    <time_frame>Assessment will be conducted on week 0, 16 and the end of study completion (once relapse occurs, an average of 1 year).</time_frame>
    <description>Questionnaire for disease-specific quality of life</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Skindex16</measure>
    <time_frame>Assessment will be conducted on week 0, 16 and the end of study completion (once relapse occurs, an average of 1 year).</time_frame>
    <description>Questionnaire for disease-specific quality of life</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>patients' attitudes, expectation and experience</measure>
    <time_frame>Interview will be conducted on week 0, 16 and the end of study completion (once relapse occurs, an average of 1 year).</time_frame>
    <description>Semi-structured individual interview will be conducted to explore patients' understanding and expectation for the combination therapy used in this study. Patients' experience of using the combination therapy will be recorded as well.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">10</enrollment>
  <condition>Psoriasis</condition>
  <arm_group>
    <arm_group_label>Chinese herbal medicine in combination with secukinumab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Oral Chinese herbal medicine (Gu Ben Hua Yu Fang decoction) and secukinumab will be used concurrently. The treatment duration for both secukinumab and oral Chinese herbal medicine is up to 16 weeks. Secukinumab will be administered by subcutaneous injection. The required dose (300 mg) is divided into two doses of 150 mg (contained in two separate syringes), which are injected at the same time. The first five doses (each consisting of 2 injections of 150 mg) are given at weekly intervals, with subsequent treatment given monthly (2 injections of 150 mg). Chinese herbal formula (Gu Ben Hua Yu Fang) decoction will be orally administrated twice a day. One pack of Gu Ben Hua Yu Fang will be taken for each time. Chinese herbal medicine (Gu Ben Hua Yu Fang) will not be used on the day of receiving secukinumab injection.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Gu Ben Hua Yu Fang decoction (Chinese herbal medicine)</intervention_name>
    <description>Chinese herbal formula (Gu Ben Hua Yu Fang) decoction will be orally administrated twice daily. One pack of Gu Ben Hua Yu Fang will be taken for each time. Chinese herbal medicine (Gu Ben Hua Yu Fang) will not be used on the day of receiving secukinumab injection.</description>
    <arm_group_label>Chinese herbal medicine in combination with secukinumab</arm_group_label>
    <other_name>Chinese herbal medicine decoction</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Secukinumab Auto-Injector [Cosentyx]</intervention_name>
    <description>Secukinumab will be administered by subcutaneous injection. The required dose (300 mg) is divided into two doses of 150 mg (contained in two separate syringes), which are injected at the same time. The first five doses (each consisting of 2 injections of 150 mg) are given at weekly intervals, with subsequent treatment given monthly (2 injections of 150 mg).</description>
    <arm_group_label>Chinese herbal medicine in combination with secukinumab</arm_group_label>
    <other_name>Cosentyx</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Psoriasis Area and Severity Index (PASI) score≥10&#xD;
&#xD;
          2. Meet the requirement of using secukinumab; without the history of inflammatory bowel&#xD;
             disease (IBD)&#xD;
&#xD;
          3. Written/signed informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        1. Unsuitable for the treatment of secukinumab&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Chuanjian Lu, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Guangdong Provincial Hospital of Traditional Chinese Medicine</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Chuanjian Lu, PhD</last_name>
    <phone>+8620-81887233</phone>
    <phone_ext>31223</phone_ext>
    <email>luchuanjian888@vip.sina.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Jingjie Yu, PhD</last_name>
    <phone>+8620-81887233</phone>
    <phone_ext>35934</phone_ext>
    <email>jingjieyu@gzucm.edu.cn</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Guangdong Provincial Hospital of Traditional Chinese Medicine</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Chuanjian Lu, PhD</last_name>
      <phone>(8620)81887233</phone>
      <phone_ext>31223</phone_ext>
      <email>luchuanjian888@vip.sina.com</email>
    </contact>
    <contact_backup>
      <last_name>Zehuai Wen, PhD</last_name>
      <phone>（86）13903008091</phone>
      <email>wenzehuai@139.com</email>
    </contact_backup>
    <investigator>
      <last_name>Chuanjian Lu, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Jingjie Yu, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 11, 2020</study_first_submitted>
  <study_first_submitted_qc>May 31, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>February 28, 2021</last_update_submitted>
  <last_update_submitted_qc>February 28, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 2, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Guangdong Provincial Hospital of Traditional Chinese Medicine</investigator_affiliation>
    <investigator_full_name>Chuanjian Lu</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Psoriasis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Antibodies, Monoclonal</mesh_term>
  </intervention_browse>
  <!-- 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/NCT04414605
org study id: BF2020-068-02
nct id: NCT04414605
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to determine whether oral Chinese herbal medicine in combination
      secukinumab is effective and safe in the treatment of severe psoriasis.
The aim of this study is to determine whether oral Chinese herbal medicine in combination
      with secukinumab is effective and safe in the treatment of severe psoriasis. Eligible
      participants will be treated with oral Chinese herbal medicine and secukinumab concurrently.
      No controlled group will be set up in this trial. The primary outcome is time to relapse.
      Secondary outcomes include Psoriasis Area and Severity Index (PASI) 75/90, PASI score
      reduction rate, physician's global assessment (PGA) score, body surface area (BSA) score,
      visual analogue scale (VAS) score, dermatology life quality index (QLQI) and Skindex 16.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Median time to relapse
time frame: Through study completion, an average of 1 year
description: Median time to relapse is a time interval. The time interval will be recorded between the end of treatment and the occurrence of relapse. Relapse was defined as loss of > 50% of maximum Psoriasis Area and Severity Index (PASI) improvement compared with pretreatment baseline.
measure: Psoriasis Area and Severity Index (PASI) score
time frame: Assessment will be conducted at week 0, 1, 2, 3, 4, and every four weeks throughout the remaining period the this trial, an average of 1 year
description: The improvement in Psoriasis Area and Severity Index (PASI) score from baseline after treatment; the scale scores ranged from 0-72. The higher the scores are, the more severe the patients suffer
measure: PASI-75
time frame: 16 weeks after treatment
description: The proportion of patients who achieve at least 75% improvement in PASI score from baseline.
measure: PASI-90
time frame: 16 weeks after treatment
description: The proportion of patients who achieve at least 90% improvement in PASI score from baseline.
measure: Physician's global assessment (PGA) score
time frame: Assessment will be conducted on week 0, 1, 2, 3, 4, and every four weeks throughout the remaining period the this trial, an average of 1 year.
description: Physician's global assessment for the condition
measure: Pruritus Scores on the Visual Analogue Scale
time frame: Assessment will be conducted on week 0, 1, 2, 3, 4, and every four weeks throughout the remaining period the this trial, an average of 1 year.
description: Pruritus will be assessed using the Visual Analogue Scales; The Scale scores ranged from 0-10; the higher the scores are, the more itching the patients suffer.
measure: BSA
time frame: Assessment will be conducted on week 0, 1, 2, 3, 4, and every four weeks throughout the remaining period the this trial, an average of 1 year.
description: the Body Surface Area
measure: Dermatology Life Quality Index (DLQI)
time frame: Assessment will be conducted on week 0, 16 and the end of study completion (once relapse occurs, an average of 1 year).
description: Questionnaire for disease-specific quality of life
measure: Skindex16
time frame: Assessment will be conducted on week 0, 16 and the end of study completion (once relapse occurs, an average of 1 year).
description: Questionnaire for disease-specific quality of life
measure: patients' attitudes, expectation and experience
time frame: Interview will be conducted on week 0, 16 and the end of study completion (once relapse occurs, an average of 1 year).
description: Semi-structured individual interview will be conducted to explore patients' understanding and expectation for the combination therapy used in this study. Patients' experience of using the combination therapy will be recorded as well.
arm group label: Chinese herbal medicine in combination with secukinumab
arm group type: Experimental
description: Oral Chinese herbal medicine (Gu Ben Hua Yu Fang decoction) and secukinumab will be used concurrently. The treatment duration for both secukinumab and oral Chinese herbal medicine is up to 16 weeks. Secukinumab will be administered by subcutaneous injection. The required dose (300 mg) is divided into two doses of 150 mg (contained in two separate syringes), which are injected at the same time. The first five doses (each consisting of 2 injections of 150 mg) are given at weekly intervals, with subsequent treatment given monthly (2 injections of 150 mg). Chinese herbal formula (Gu Ben Hua Yu Fang) decoction will be orally administrated twice a day. One pack of Gu Ben Hua Yu Fang will be taken for each time. Chinese herbal medicine (Gu Ben Hua Yu Fang) will not be used on the day of receiving secukinumab injection.
intervention type: Drug
intervention name: Gu Ben Hua Yu Fang decoction (Chinese herbal medicine)
description: Chinese herbal formula (Gu Ben Hua Yu Fang) decoction will be orally administrated twice daily. One pack of Gu Ben Hua Yu Fang will be taken for each time. Chinese herbal medicine (Gu Ben Hua Yu Fang) will not be used on the day of receiving secukinumab injection.
arm group label: Chinese herbal medicine in combination with secukinumab
other name: Chinese herbal medicine decoction
intervention type: Drug
intervention name: Secukinumab Auto-Injector [Cosentyx]
description: Secukinumab will be administered by subcutaneous injection. The required dose (300 mg) is divided into two doses of 150 mg (contained in two separate syringes), which are injected at the same time. The first five doses (each consisting of 2 injections of 150 mg) are given at weekly intervals, with subsequent treatment given monthly (2 injections of 150 mg).
arm group label: Chinese herbal medicine in combination with secukinumab
other name: Cosentyx
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Chuanjian Lu, PhD
role: Principal Investigator
affiliation: Guangdong Provincial Hospital of Traditional Chinese Medicine
last name: Chuanjian Lu, PhD
phone: +8620-81887233
phone ext: 31223
email: luchuanjian888@vip.sina.com
last name: Jingjie Yu, PhD
phone: +8620-81887233
phone ext: 35934
email: jingjieyu@gzucm.edu.cn
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Guangdong Provincial Hospital of Traditional Chinese Medicine
investigator full name: Chuanjian Lu
investigator title: Professor
mesh term: Psoriasis
mesh term: Antibodies, Monoclonal