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/NCT05975268</url>
    </required_header>
    <id_info>
      <org_study_id>JS005-005-III-PsO</org_study_id>
      <nct_id>NCT05975268</nct_id>
    </id_info>
    <brief_title>A Clinical Study to Evaluate the Efficacy and Safety of Subcutaneous JS005 Injection in the Treatment of Adults With Moderate to Severe Chronic Plaque Psoriasis</brief_title>
    <official_title>A Multicenter, Randomized, Double-blind, Parallel, Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of Subcutaneous JS005 Injection in the Treatment of Adults With Moderate to Severe Chronic Plaque Psoriasis</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Shanghai Junshi Bioscience Co., Ltd.</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Shanghai Junshi Bioscience 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 a multicenter, randomized, double-blind, parallel, placebo-controlled Phase III&#xD;
        clinical study to evaluate the efficacy and safety of JS005 in 702 adult patients with&#xD;
        moderate-to-severe chronic plaque psoriasis&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The study consisted of four periods: screening period (up to 4 weeks), induction period (12&#xD;
        weeks), maintenance period (40 weeks) and follow-up period (8 weeks). This study planned to&#xD;
        recruit 702 subjects, who were randomized into JS005 300mg group (234 subjects), JS005 150mg&#xD;
        group (234 subjects) and placebo group (234 subjects) at a ratio of 1:1:1, and were&#xD;
        stratified by whether they had previsouly received biologic treatments (continuous biologic&#xD;
        treatment for ≥3 months at recommended doses or intolerance for safety reasons) and body&#xD;
        weight (≥70 kg or &lt; 70 kg).&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 28, 2023</start_date>
    <completion_date type="Anticipated">October 10, 2025</completion_date>
    <primary_completion_date type="Anticipated">May 31, 2024</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>
      <intervention_model_description>Parallel</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
      <masking_description>The study uses a double-blind design in which subjects, investigators, and other researchers will remain blind to the allocation of the study drug and placebo.&#xD;
  If serious adverse events occur to subjects during the study, the investigator must be informed of the treatment received by the subjects before appropriate treatment can be given. For safety reasons, the investigator may unblind the subjects urgently after obtaining the consent of the sponsor's medical monitor.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Change in PASI 90</measure>
      <time_frame>From week 0 to week 12</time_frame>
      <description>The proportion of patients who achieved at least 90% improvement from baseline in psoriasis area and severity index (PASI 90) at week 12</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in sPGA</measure>
      <time_frame>From week 0 to week 12</time_frame>
      <description>The proportion of patients who achieved a static physician Comprehensive Assessment (sPGA) score of 0 or 1 at week 12.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Patients achieving PASI 75 at Week 12</measure>
      <time_frame>From week 0 to week 12</time_frame>
      <description>The proportion of patients who achieved at least 75% improvement from baseline in psoriasis area and severity index (PASI 90) at week 12</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patients achieving PASI 100 at Week 12</measure>
      <time_frame>From week 0 to week 12</time_frame>
      <description>The proportion of patients who achieved at least 100% improvement from baseline in psoriasis area and severity index (PASI 90) at week 12</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportion of subjects with a sPGA score of 0 at week 12</measure>
      <time_frame>From week 0 to week 12</time_frame>
      <description>The proportion of patients who achieved at least 0 at week 12</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportion of subjects with a DLQI score of 0/1 at week 12</measure>
      <time_frame>From week 0 to week 12</time_frame>
      <description>The proportion of patients who with a DLQI score at least 0/1 at week 12</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patients achieving PASI 75 at Week 52</measure>
      <time_frame>From week 0 to week 52</time_frame>
      <description>Proportion of participants with a PASI score improvement of at least 75% (PASI 75) from baseline at week 52</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time to PASI 75/90 response</measure>
      <time_frame>From week 0 to week 12</time_frame>
      <description>Time to PASI 75/90 response within 12 weeks</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time to sPGA 0/1 response</measure>
      <time_frame>From week 0 to week 12</time_frame>
      <description>Time to sPGA 0/1 response within 12 weeks</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patients achieving PASI 90 at Week 52</measure>
      <time_frame>From week 0 to week 52</time_frame>
      <description>Proportion of participants with a PASI score improvement of at least 90 (PASI 90) from baseline at week 52</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patients achieving PASI 100 at Week 52</measure>
      <time_frame>From week 0 to week 52</time_frame>
      <description>Proportion of participants with a PASI score improvement of at least 100 from baseline (PASI 100) at week 52</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">702</enrollment>
    <condition>Moderate to Severe Chronic Plaque Psoriasis</condition>
    <arm_group>
      <arm_group_label>JS005 150mg (recombinant humanized monoclonal antibody against IL-17A)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>JS005 300mg (recombinant humanized monoclonal antibody against IL-17A)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>JS005 (recombinant humanized monoclonal antibody against IL-17A)</intervention_name>
      <description>JS005/placebo</description>
      <arm_group_label>JS005 150mg (recombinant humanized monoclonal antibody against IL-17A)</arm_group_label>
      <arm_group_label>JS005 300mg (recombinant humanized monoclonal antibody against IL-17A)</arm_group_label>
      <arm_group_label>Placebo</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Subjects voluntarily particpate in this clinical study and sign the informed consent&#xD;
               form.&#xD;
  &#xD;
            2. Male and female patients aged 18-75 years at the time of screening (both inclusive).&#xD;
  &#xD;
            3. Fertile female subjects must be willing to use a highly effective contraceptive method&#xD;
               during the study period and 20 weeks (expected 5 half-lives) after the last study drug&#xD;
               administration and have a negative pregnancy test during the screening period and&#xD;
               prior to randomization.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Pregnant and lactating women.&#xD;
  &#xD;
            2. A history of inflammatory bowel disease or other conditions with a high risk of&#xD;
               perforation (e.g., severe gastrointestinal ulcers, etc.) or with other active&#xD;
               autoimmune diseases (e.g., systemic lupus erythematosus, Sarcoidosis, etc.).&#xD;
  &#xD;
            3. Have a type of psoriasis other than chronic plaque psoriasis (e.g., pustular,&#xD;
               erythrodermic, and guttate psoriasis), drug-induced psoriasis, or have an active&#xD;
               inflammatory skin disease other than psoriasis&#xD;
  &#xD;
            4. Use of phototherapy, including but not limited to ultraviolet A phototherapy (with or&#xD;
               without psoralens), ultraviolet B phototherapy, or excimer laser within 4 weeks prior&#xD;
               to randomization. Subjects are unwilling to avoid excessive sunlight exposure within 4&#xD;
               weeks prior to randomization and during the study period;&#xD;
  &#xD;
            5. A (current) history of systemic infection or serious infection requiring&#xD;
               hospitalization and/or intravenous anti-infective therapy (e.g., antibiotics,&#xD;
               antifungal agents, antiviral agents) within 12 weeks prior to randomization; a history&#xD;
               of any active infection, other than common upper respiratory infections, within 2&#xD;
               weeks prior to randomization;&#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>Jianzhong Zhang, M.D.</last_name>
      <phone>8618001315877</phone>
      <email>Rmzjz@126.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>The First Affiliated Hospital of Bengbu Medical College</name>
        <address>
          <city>Bengbu</city>
          <state>Anhui</state>
          <zip>233004</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Hongfang Han, M.D.</last_name>
        <phone>8613865019127</phone>
        <email>627075942@qq.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>The Second Affiliated Hospital of Anhui Medical University</name>
        <address>
          <city>Hefei</city>
          <state>Anhui</state>
          <zip>230601</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Chunjun Yang, M.D.</last_name>
        <phone>8613966681316</phone>
        <email>aydefyllwyhbgs@163.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Beijing Friendship Hospital, Capital Medical University</name>
        <address>
          <city>Beijing</city>
          <state>Beijing</state>
          <zip>100044</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Lingfeng Li, M.D.</last_name>
        <phone>8613693620186</phone>
        <email>zoonli@sina.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Beijing Tongren Hospital Affiliated to Capital Medical University</name>
        <address>
          <city>Beijing</city>
          <state>Beijing</state>
          <zip>100044</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Aihua Wei, M.D.</last_name>
        <phone>8615810585889</phone>
        <email>weiaihua3000@163.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>China-Japan Friendship Hospital</name>
        <address>
          <city>Beijing</city>
          <state>Beijing</state>
          <zip>100044</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Yong Cui, M.D.</last_name>
        <phone>8617150070682</phone>
        <email>wuhucuiyong@vip.163.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Peking University People's Hospital</name>
        <address>
          <city>Beijing</city>
          <state>Beijing</state>
          <zip>100044</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Jianzhong Zhang, M.D.</last_name>
        <phone>+8618001315877</phone>
        <email>Rmzjz@126.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Peking University Third Hospital</name>
        <address>
          <city>Beijing</city>
          <state>Beijing</state>
          <zip>100044</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Wenhui Wang, M.D.</last_name>
        <phone>8618618269437</phone>
        <email>wwh0608@126.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Ningbo Huamei Hospital, University of Chinese Academy of Sciences</name>
        <address>
          <city>Beijing</city>
          <state>Beijing</state>
          <zip>100864</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Jinyan Wang, M.D.</last_name>
        <phone>8613586795265</phone>
        <email>rypamy@163.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>The First Affiliated Hospital of Chongqing Medical University</name>
        <address>
          <city>Chongqing</city>
          <state>Chongqing</state>
          <zip>400016</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Aijun Chen, M.D.</last_name>
        <phone>8613062377863</phone>
        <email>1360999716@qq.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>The First Affiliated Hospital of Fujian Medical University</name>
        <address>
          <city>Fuzhou</city>
          <state>Fujian</state>
          <zip>350005</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Chao Ji, M.D.</last_name>
        <phone>8618651619908</phone>
        <email>surpassing_ji@163.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>The Second Affiliated Hospital of Xiamen Medical College</name>
        <address>
          <city>Xiamen</city>
          <state>Fujian</state>
          <zip>361023</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Mingkai Ji, M.D.</last_name>
        <phone>8613075959049</phone>
        <email>Mingkai_ji@163.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Lanzhou University Second Hospital</name>
        <address>
          <city>Lanzhou</city>
          <state>Gansu</state>
          <zip>730030</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Taoxiang Niu, M.D.</last_name>
        <phone>8615193189096</phone>
        <email>niutx@163.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Dongguan People's Hospital</name>
        <address>
          <city>Dongguan</city>
          <state>Guangdong</state>
          <zip>523018</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Guangming Han, M.D.</last_name>
        <phone>8613533391069</phone>
        <email>Ghan54321@163.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Guangdong General Hospital</name>
        <address>
          <city>Guangzhou</city>
          <state>Guangdong</state>
          <zip>510080</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Zhu Shen, M.D.</last_name>
        <phone>8613983174426</phone>
        <email>zhshencq@163.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Dermatology Hospital of Southern Medical University</name>
        <address>
          <city>Guangzhou</city>
          <state>Guangdong</state>
          <zip>510091</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Xiaohua Wang, M.D.</last_name>
        <phone>8613763359607</phone>
        <email>wxh-21773@163.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Guangzhou First People's Hospital</name>
        <address>
          <city>Guangzhou</city>
          <state>Guangdong</state>
          <zip>510180</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Jiang Wu, M.D.</last_name>
        <phone>8618922182868</phone>
        <email>wj642@163.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Sun Yat-sen Memorial Hospital, Sun Yat-sen University</name>
        <address>
          <city>Guangzhou</city>
          <state>Guangdong</state>
          <zip>518107</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Qing Guo, M.D.</last_name>
        <phone>8618922182868</phone>
        <email>guoqingzsy@163.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Shenzhen People's Hospital</name>
        <address>
          <city>Shenzhen</city>
          <state>Guangdong</state>
          <zip>518020</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Jianglin Zhang, M.D.</last_name>
        <phone>8613873143466</phone>
        <email>zhang.jianglin@szhospital.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>The Affiliated Hospital of Chengde Medical College</name>
        <address>
          <city>Chengde</city>
          <state>Hebei</state>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Xisuo Duan, M.D.</last_name>
        <phone>8615633142680</phone>
        <email>15633142680@163.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>The First Hospital of Hebei Medical University</name>
        <address>
          <city>Shijiazhuang</city>
          <state>Hebei</state>
          <zip>050000</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Guoqiang Zhang, M.D.</last_name>
        <phone>8618633888122</phone>
        <email>zgq810328@sina.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Xingtai People's Hospital</name>
        <address>
          <city>Xingtai</city>
          <state>Hebei</state>
          <zip>054031</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Fang Cheng, M.D.</last_name>
        <phone>8618931912286</phone>
        <email>18931912286@163.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Nanyang city first People's Hospital</name>
        <address>
          <city>Nanyang</city>
          <state>Henan</state>
          <zip>473000</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Rixin Chen, M.D.</last_name>
        <phone>8613849795170</phone>
        <email>pfkgcpby@163.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>The First Affiliated Hospital of Xinxiang Medical College</name>
        <address>
          <city>Xinxiang</city>
          <state>Henan</state>
          <zip>453100</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Zhongwei Tian, M.D.</last_name>
        <phone>8615637358828</phone>
        <email>zhonwt@xxmu.edu.cn</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Jingzhou Central Hospital</name>
        <address>
          <city>Jingzhou</city>
          <state>Hubei</state>
          <zip>434020</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Tongxiang Zeng, M.D.</last_name>
        <phone>8613339737387</phone>
        <email>331867948@qq.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Shiyan City People's Hospital</name>
        <address>
          <city>Shiyan</city>
          <state>Hubei</state>
          <zip>442000</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Zudong Meng, M.D.</last_name>
        <phone>8613997837543</phone>
        <email>1970547910@qq.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Wuhan University People's Hospital</name>
        <address>
          <city>Wuhan</city>
          <state>Hubei</state>
          <zip>430060</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Tiechi Lei, M.D.</last_name>
        <phone>8615337173507</phone>
        <email>tiechilei@126.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>The Second Xiangya Hospital, Central South University</name>
        <address>
          <city>Changsha</city>
          <state>Hunan</state>
          <zip>410008</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Rong Xiao, M.D.</last_name>
        <phone>8613808425555</phone>
        <email>xiaorong65@aliyun.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Xiangya Third Hospital, Central South University</name>
        <address>
          <city>Changsha</city>
          <state>Hunan</state>
          <zip>410013</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Jianyun Lu, M.D.</last_name>
        <phone>8613975130008</phone>
        <email>1010739024@qq.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Lianyungang First People's Hospital</name>
        <address>
          <city>Lianyungang</city>
          <state>Jiangsu</state>
          <zip>222002</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Hong Ren, M.D.</last_name>
        <phone>8618961326020</phone>
        <email>irb_lygyyy@163.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>The First Affiliated Hospital of Soochow University</name>
        <address>
          <city>Suzhou</city>
          <state>Jiangsu</state>
          <zip>215123</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Jisheng Liu, M.D.</last_name>
        <phone>8613913719333</phone>
        <email>yzl6405@163.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Wuxi Second People's Hospital</name>
        <address>
          <city>Wuxi</city>
          <state>Jiangsu</state>
          <zip>214002</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Xiaohong Zhu, M.D.</last_name>
        <phone>8613395172837</phone>
        <email>zxh6801@126.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Yancheng First People's Hospital</name>
        <address>
          <city>Yancheng</city>
          <state>Jiangsu</state>
          <zip>224006</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Pingping Qin, M.D.</last_name>
        <phone>8613601413122</phone>
        <email>ycyylwh@163.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Affiliated Hospital of Jiangsu University</name>
        <address>
          <city>Zhenjiang</city>
          <state>Jiangsu</state>
          <zip>212000</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Yumei Li, M.D.</last_name>
        <phone>8613914569541</phone>
        <email>yumei@aliyun.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>The First Affiliated Hospital of Gannan Medical College</name>
        <address>
          <city>Ganzhou</city>
          <state>Jiangxi</state>
          <zip>341000</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Jingfa Lu, M.D.</last_name>
        <phone>8613479725817</phone>
        <email>lujingfa@126.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Jiangxi Dermatology Hospital</name>
        <address>
          <city>Nanchang</city>
          <state>Jiangxi</state>
          <zip>330000</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Fengming Hu, M.D.</last_name>
        <phone>8618907802429</phone>
        <email>1262200957@qq.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>The Second Affiliated Hospital of Nanchang University</name>
        <address>
          <city>Nanchang</city>
          <state>Jiangxi</state>
          <zip>330006</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Meiying Jiang, M.D.</last_name>
        <phone>8613870913263</phone>
        <email>151465672@qq.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Bethune First Hospital of Jilin University</name>
        <address>
          <city>Changchun</city>
          <state>Jilin</state>
          <zip>130021</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Shanshan Li, M.D</last_name>
        <phone>8613756661632</phone>
        <email>shansalee@163.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Panjin Liao oil precious stone flower hospital</name>
        <address>
          <city>Panjin</city>
          <state>Liaoning</state>
          <zip>124011</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Yingxia He, M.D.</last_name>
        <phone>8613904273211</phone>
        <email>1462619572@qq.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Shengjing Hospital affiliated to China Medical University</name>
        <address>
          <city>Shenyang</city>
          <state>Liaoning</state>
          <zip>110004</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Xiuping Han, M.D.</last_name>
        <phone>8618940251646</phone>
        <email>hanxiuping66@126.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Shenyang Hospital of Integrated Chinese and Western Medicine</name>
        <address>
          <city>Shenyang</city>
          <state>Liaoning</state>
          <zip>110021</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Xiaodong Sun, M.D.</last_name>
        <phone>8613591454517</phone>
        <email>gemmapeter@163.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>North East Central International Hospital Limited</name>
        <address>
          <city>Shenyang</city>
          <state>Liaoning</state>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Shifa Zhang, M.D.</last_name>
        <phone>8613190010100</phone>
        <email>zhangshifa_1963@126.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Baotou Central Hospital</name>
        <address>
          <city>Baotou</city>
          <state>Neimenggu</state>
          <zip>014040</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Guohui Zhang, M.D.</last_name>
        <phone>13734809158</phone>
        <email>1259314465@qq.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Inner Mongolia Baotou Steel Hospital</name>
        <address>
          <city>Baotou</city>
          <state>Neimengu</state>
          <zip>010000</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Min Zhang, M.D.</last_name>
        <phone>8613847245128</phone>
        <email>nmgzm@126.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Ningxia Medical University General Hospital</name>
        <address>
          <city>Yinchuan</city>
          <state>Ningxia</state>
          <zip>750004</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Nan Yu, M.D.</last_name>
        <phone>8613895095009</phone>
        <email>13895095009@163.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Shandong Dermatology Hospital</name>
        <address>
          <city>Jinan</city>
          <state>Shandong</state>
          <zip>250000</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Furen Zhang, M.D.</last_name>
        <phone>8613608921718</phone>
        <email>zhangfuren@hotmail.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Jinan Central Hospital</name>
        <address>
          <city>Jinan</city>
          <state>Shandong</state>
          <zip>250013</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Lihua Wang, M.D.</last_name>
        <phone>8615318816237</phone>
        <email>15318816237@163.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Shanghai Dermatology Hospital</name>
        <address>
          <city>Shanghai</city>
          <state>Shanghai</state>
          <zip>200050</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Yangfeng Ding, M.D.</last_name>
        <phone>8618017336636</phone>
        <email>dingyangfeng@aliyun.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>The Second Hospital of Shanxi Medical University City:Taiyuan</name>
        <address>
          <city>Taiyuan</city>
          <state>Shanxi</state>
          <zip>030001</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Wenli Feng, M.D.</last_name>
        <phone>8613935198008</phone>
        <email>fwl92@hotmail.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>The First Affiliated Hospital of Xi 'an Jiaotong University City:Xian</name>
        <address>
          <city>Xi'an</city>
          <state>Shanxi</state>
          <zip>710061</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Miao Zheng, M.D.</last_name>
        <phone>8615319931238</phone>
        <email>zenyan66@126.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Medicine School of Xi'an Jiaotong University</name>
        <address>
          <city>Xian</city>
          <state>Shanxi</state>
          <zip>710004</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Songmei Geng, M.D.</last_name>
        <phone>8613060423612</phone>
        <email>gsm312@yahoo.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Chengdu Second People's Hospital</name>
        <address>
          <city>Chengdu</city>
          <state>Sichuan</state>
          <zip>610017</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Yanyan Feng, M.D.</last_name>
        <phone>8619150169967</phone>
        <email>fyymed@163.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>West China Hospital of Sichuan University</name>
        <address>
          <city>Chengdu</city>
          <state>Sichuan</state>
          <zip>610041</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Wei Li, M.D.</last_name>
        <phone>8618980601695</phone>
        <email>724564806@qq.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Suining Central Hospital</name>
        <address>
          <city>Suining</city>
          <state>Sichuan</state>
          <zip>629000</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Chunshui Yu, M.D.</last_name>
        <phone>8618008256917</phone>
        <email>373405810@qq.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital</name>
        <address>
          <city>Tianjin</city>
          <state>Tianjin</state>
          <zip>300120</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Litao Zhang, M.D.</last_name>
        <phone>8618602228122</phone>
        <email>zhanglitao@medmail.com.cn</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>The Second Affiliated Hospital of Kunming Medical University</name>
        <address>
          <city>Kunming</city>
          <state>Yunnan</state>
          <zip>650118</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Yunhui Yang, M.D.</last_name>
        <phone>8613888139863</phone>
        <email>danqid128@sina.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Hangzhou Third People's Hospital</name>
        <address>
          <city>Hangzhou</city>
          <state>Zhejiang</state>
          <zip>310002</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Tianhong Xu, M.D.</last_name>
        <phone>8613282842619</phone>
        <email>1467314735@qq.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Hangzhou First People's Hospital</name>
        <address>
          <city>Hangzhou</city>
          <state>Zhejiang</state>
          <zip>310006</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Liming Wu, M.D.</last_name>
        <phone>8613750837205</phone>
        <email>18957118053@163.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Zhejiang Provincial People's Hospital</name>
        <address>
          <city>Hangzhou</city>
          <state>Zhejiang</state>
          <zip>310014</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Xiaohua Tao, M.D.</last_name>
        <phone>8613505811700</phone>
        <email>13505811700@163.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Run Run Shaw Hospital, Zhejiang University School of Medicine</name>
        <address>
          <city>Hangzhou</city>
          <state>Zhejiang</state>
          <zip>310016</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Hao Cheng, M.D.</last_name>
        <phone>8613588706943</phone>
        <email>xumingsrrsh@foxmail.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>The First Hospital of Jiaxing</name>
        <address>
          <city>Jiaxing</city>
          <state>Zhejiang</state>
          <zip>314001</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Wenhao Yin, M.D.</last_name>
        <phone>8613957322306</phone>
        <email>whyin69@sina.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>The First Affiliated Hospital of Wenzhou Medical University</name>
        <address>
          <city>Wenzhou</city>
          <state>Zhejiang</state>
          <zip>325000</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Zhiming Li, M.D.</last_name>
        <phone>8615988718867</phone>
        <email>wyyyll01@163.com</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>July 27, 2023</study_first_submitted>
    <study_first_submitted_qc>July 27, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 3, 2023</study_first_posted>
    <last_update_submitted>September 13, 2023</last_update_submitted>
    <last_update_submitted_qc>September 13, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 14, 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>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Antibodies</mesh_term>
      <mesh_term>Antibodies, Monoclonal</mesh_term>
    </intervention_browse>
    <!-- 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/NCT05975268
  org study id: JS005-005-III-PsO
  nct id: NCT05975268
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  This is a multicenter, randomized, double-blind, parallel, placebo-controlled Phase III
        clinical study to evaluate the efficacy and safety of JS005 in 702 adult patients with
        moderate-to-severe chronic plaque psoriasis
  The study consisted of four periods: screening period (up to 4 weeks), induction period (12
        weeks), maintenance period (40 weeks) and follow-up period (8 weeks). This study planned to
        recruit 702 subjects, who were randomized into JS005 300mg group (234 subjects), JS005 150mg
        group (234 subjects) and placebo group (234 subjects) at a ratio of 1:1:1, and were
        stratified by whether they had previsouly received biologic treatments (continuous biologic
        treatment for ≥3 months at recommended doses or intolerance for safety reasons) and body
        weight (≥70 kg or < 70 kg).
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Parallel
  primary purpose: Treatment
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  masking description: The study uses a double-blind design in which subjects, investigators, and other researchers will remain blind to the allocation of the study drug and placebo.
  If serious adverse events occur to subjects during the study, the investigator must be informed of the treatment received by the subjects before appropriate treatment can be given. For safety reasons, the investigator may unblind the subjects urgently after obtaining the consent of the sponsor's medical monitor.
  measure: Change in PASI 90
  time frame: From week 0 to week 12
  description: The proportion of patients who achieved at least 90% improvement from baseline in psoriasis area and severity index (PASI 90) at week 12
  measure: Change in sPGA
  time frame: From week 0 to week 12
  description: The proportion of patients who achieved a static physician Comprehensive Assessment (sPGA) score of 0 or 1 at week 12.
  measure: Patients achieving PASI 75 at Week 12
  time frame: From week 0 to week 12
  description: The proportion of patients who achieved at least 75% improvement from baseline in psoriasis area and severity index (PASI 90) at week 12
  measure: Patients achieving PASI 100 at Week 12
  time frame: From week 0 to week 12
  description: The proportion of patients who achieved at least 100% improvement from baseline in psoriasis area and severity index (PASI 90) at week 12
  measure: Proportion of subjects with a sPGA score of 0 at week 12
  time frame: From week 0 to week 12
  description: The proportion of patients who achieved at least 0 at week 12
  measure: Proportion of subjects with a DLQI score of 0/1 at week 12
  time frame: From week 0 to week 12
  description: The proportion of patients who with a DLQI score at least 0/1 at week 12
  measure: Patients achieving PASI 75 at Week 52
  time frame: From week 0 to week 52
  description: Proportion of participants with a PASI score improvement of at least 75% (PASI 75) from baseline at week 52
  measure: Time to PASI 75/90 response
  time frame: From week 0 to week 12
  description: Time to PASI 75/90 response within 12 weeks
  measure: Time to sPGA 0/1 response
  time frame: From week 0 to week 12
  description: Time to sPGA 0/1 response within 12 weeks
  measure: Patients achieving PASI 90 at Week 52
  time frame: From week 0 to week 52
  description: Proportion of participants with a PASI score improvement of at least 90 (PASI 90) from baseline at week 52
  measure: Patients achieving PASI 100 at Week 52
  time frame: From week 0 to week 52
  description: Proportion of participants with a PASI score improvement of at least 100 from baseline (PASI 100) at week 52
  arm group label: JS005 150mg (recombinant humanized monoclonal antibody against IL-17A)
  arm group type: Experimental
  arm group label: JS005 300mg (recombinant humanized monoclonal antibody against IL-17A)
  arm group type: Experimental
  arm group label: Placebo
  arm group type: Placebo Comparator
  intervention type: Biological
  intervention name: JS005 (recombinant humanized monoclonal antibody against IL-17A)
  description: JS005/placebo
  arm group label: JS005 150mg (recombinant humanized monoclonal antibody against IL-17A)
  arm group label: JS005 300mg (recombinant humanized monoclonal antibody against IL-17A)
  arm group label: Placebo
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: No
  last name: Jianzhong Zhang, M.D.
  phone: 8618001315877
  email: Rmzjz@126.com
  facility: 
  status: Not yet recruiting
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  status: Not yet recruiting
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  status: Recruiting
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  contact: 
  country: China
  responsible party type: Sponsor
  mesh term: Psoriasis
  mesh term: Antibodies
  mesh term: Antibodies, Monoclonal