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/NCT05970432</url>
    </required_header>
    <id_info>
      <org_study_id>TQH2722-II-01</org_study_id>
      <nct_id>NCT05970432</nct_id>
    </id_info>
    <brief_title>A Clinical Study of TQH2722 Injection in the Treatment of Moderate to Severe Atopic Dermatitis</brief_title>
    <official_title>A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Clinical Trial Evaluating the Efficacy and Safety of TQH2722 Injection in Subjects With Moderate to Severe Atopic Dermatitis</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Chia Tai Tianqing Pharmaceutical Group Co., Ltd.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Chia Tai Tianqing Pharmaceutical Group 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 phase II clinical trials is multicenter, randomized, double-blind, placebo-controlled to&#xD;
        assess the effectiveness and safety of TQH2722 injection in the treatment of subjects with&#xD;
        moderate to severe atopic dermatitis.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">June 19, 2023</start_date>
    <completion_date type="Anticipated">March 2024</completion_date>
    <primary_completion_date type="Anticipated">March 2024</primary_completion_date>
    <phase>Phase 2</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>Eczema area and severity (EASI)-75 (≥75% improvement from baseline).</measure>
      <time_frame>Up to 16 weeks.</time_frame>
      <description>Proportion of participants with eczema area and severity (EASI)-75 (≥75% improvement from baseline) at week 16.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Investigator's general assessment (IGA)</measure>
      <time_frame>Up to 16 weeks.</time_frame>
      <description>Proportion of subjects with, the investigator's overall assessment (IGA) of 0 or 1 (6-point in total) at week 16.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Eczema area and severity (EASI)-90 (≥90% improvement from baseline).</measure>
      <time_frame>Up to 16 weeks.</time_frame>
      <description>Proportion of participants with EASI-90 at week 16.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Eczema area and severity (EASI)</measure>
      <time_frame>Up to 16 weeks.</time_frame>
      <description>Percentage change in EASI score from baseline to week 16;</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in investigator's general assessment (IGA)</measure>
      <time_frame>Up to 16 weeks.</time_frame>
      <description>Change (or percentage change) in IGA score from baseline to week 16;</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Body surface area (%BSA)</measure>
      <time_frame>Up to 16 weeks.</time_frame>
      <description>%BSA change from baseline to week 16</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Treatment Emergent Adverse Events (TEAE)</measure>
      <time_frame>Up to 20 weeks.</time_frame>
      <description>Incidence of TEAE from baseline to week 20 determined by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTC AE) V5.0.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence of anti-drug antibodies (ADAs)</measure>
      <time_frame>Up to 24 weeks.</time_frame>
      <description>The incidence of anti-drug antibodies (ADAs) of subjects and their titer, the incidence of neutralizing antibodies (Nab). If the subject is tested positive for ADA, a neutralizing antibody is added in the test.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence of neutralizing antibodies</measure>
      <time_frame>Up to 24 weeks.</time_frame>
      <description>If the subject is tested positive for ADA, a neutralizing antibody is added.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Peak Itch numerical rating scale (NRS)</measure>
      <time_frame>Up to 16 weeks.</time_frame>
      <description>Peak Itch NRS changes from baseline to week 16. The total score is 10, with higher scores indicating more severe pruritus.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Dermatology Life Quality Index (DLQI) scores</measure>
      <time_frame>Up to 16 weeks.</time_frame>
      <description>DLQI scores change from baseline to week 16, the scores are rated as None, Not Relevant, and 0-3, with higher values representing more serious disease.</description>
    </secondary_outcome>
    <number_of_arms>4</number_of_arms>
    <enrollment type="Anticipated">160</enrollment>
    <condition>Atopic Dermatitis</condition>
    <arm_group>
      <arm_group_label>TQH2722 injection 300mg-150mg</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants received subcutaneous injection of 300 mg TQH2722 injection + 600 mg placebo on day 1, followed by subcutaneous injection of 150 mg TQH2722 injection + 300 mg placebo on days 15, 29, 43, 57, 71, 85, 99.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>TQH2722 injection 600mg-300mg</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants received subcutaneous injection of 600 mg TQH2722 injection + 300 mg placebo on day 1, followed by subcutaneous injection of 300 mg TQH2722 injection + 150 mg placebo on days 15, 29, 43, 57, 71, 85, 99.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>TQH2722 injection 900mg-450mg</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants received subcutaneous injection of 900 mg TQH2722 injection on day 1, followed by subcutaneous injection of 450 mg TQH2722 injection on days 15, 29, 43, 57, 71, 85, 99.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>TQH2722 injection matching Placebo</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Subjects received 900mg placebo injection subcutaneously on day 1, followed by 450mg placebo injection on days 15, 29, 43, 57, 71, 85, 99.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>TQH2722 injection 300mg-150mg</intervention_name>
      <description>TQH2722 injection is a fully human monoclonal antibody that interfering with the signal cascade.</description>
      <arm_group_label>TQH2722 injection 300mg-150mg</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>TQH2722 injection 600mg-300mg</intervention_name>
      <description>TQH2722 injection is a fully human monoclonal antibody that thereby interfering with the signal cascade.</description>
      <arm_group_label>TQH2722 injection 600mg-300mg</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>TQH2722 injection 900mg-450mg</intervention_name>
      <description>TQH2722 injection is a fully human monoclonal antibody that thereby interfering with the signal cascade.</description>
      <arm_group_label>TQH2722 injection 900mg-450mg</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>TQH2722 injection matching Placebo</intervention_name>
      <description>Placebo without active substance.</description>
      <arm_group_label>TQH2722 injection matching Placebo</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age 18-65 (when signing informed consent), regardless of gender;&#xD;
  &#xD;
            -  Meets 2014 American Academy of Dermatology (AAD) criteria with diagnosis of atopic&#xD;
               dermatitis (AD); In addition, history of AD prior to screening ≥ 6 months; Eczema was&#xD;
               previously diagnosed but met the 2014 AAD criteria and can still be enrolled.&#xD;
  &#xD;
            -  Patients with moderate to severe AD at screening and baseline visit (shall meet all 3&#xD;
               criteria as follows):&#xD;
  &#xD;
                 1. total area of AD lesions≥ 10% BSA;&#xD;
  &#xD;
                 2. IGA ≥3 points;&#xD;
  &#xD;
                 3. EASI ≥ 16 points;&#xD;
  &#xD;
            -  Baseline peak pruritus NRS ≥4 (The average peak pruritus intensity score in baseline&#xD;
               peak pruritus NRS will be calculated based on the average of the peak pruritus&#xD;
               intensity NRS score (daily score range 0-10) for each day during the 7 days prior to&#xD;
               randomization. A minimum of 4 days out of 7 days of scoring is required to calculate&#xD;
               the baseline average score. If the patient's reporting days are less than 4 days in&#xD;
               the 7 days prior to the planned randomization date, randomization should be postponed&#xD;
               until the requirements are met, but not beyond the maximum period of 14 days for&#xD;
               screening);&#xD;
  &#xD;
            -  6 months prior to the screening period, insufficient response to stable (≥1 month)&#xD;
               topical corticosteroids (TCS) or calcineurin inhibitors (TCI) (insufficient response&#xD;
               defined as at least 28 days even if the daily regimen of moderate-high potency TCS (±&#xD;
               topical TCI, if applicable) is at least 28 days, or to the maximum recommended course&#xD;
               of treatment (eg, ultra-potent TCS - 14 days) in the product prescribing information&#xD;
               (whichever is shorter), Failure to achieve or maintain disease remission or low&#xD;
               disease activity (equivalent to IGA 0 [=none]-2 [=mild]). or patients who have&#xD;
               received a record of systemic treatment (adequate dose, adequate course) of AD in the&#xD;
               past 6 months are also considered to have insufficient response to topical drug&#xD;
               therapy, and may be selected for trial after appropriate drug elution and approval by&#xD;
               the sponsor);&#xD;
  &#xD;
            -  Before the first dose, subjects must have continuously used the emollient twice a day&#xD;
               for at least 1 week and maintained throughout the trial (Note: the emollient is&#xD;
               provided by the sponsor);&#xD;
  &#xD;
            -  Be able to read and understand, and be willing to sign informed consent forms;&#xD;
  &#xD;
            -  Willingness and compliance with research visits and related procedures;&#xD;
  &#xD;
            -  Female participants of childbearing age should agree that contraception (e.g.,&#xD;
               intrauterine devices, pills, or condoms) must be used during the study period and for&#xD;
               6 months after the end of the study; Negative serum pregnancy test within 7 days prior&#xD;
               to first dose and must be a non-lactating subject; Male subjects should agree that&#xD;
               contraception must be used during the study period and for 6 months after the end of&#xD;
               the study period.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Participants who received the following treatments within the following limited time&#xD;
               prior to randomization:&#xD;
  &#xD;
                 1. Have used any of the following treatments within 4 weeks or the investigator&#xD;
                    believes that the following treatments may be required:&#xD;
                    immunosuppressants/immunomodulatory drugs (eg, systemic glucocorticosteroids,&#xD;
                    cyclosporine, mycophenolate mofetil, interferon γ (IFN-γ), azathioprine, and&#xD;
                    methotrexate); AD phototherapy;&#xD;
  &#xD;
                 2. Oral Janus Kinase (JAK) inhibitors (including but not limited to upadacitinib)&#xD;
                    used within 2 weeks;&#xD;
  &#xD;
                 3. Received systemic traditional Chinese medicine (TCM) treatment within 4 weeks; or&#xD;
                    within 1 week, topical TCM;&#xD;
  &#xD;
                 4. Treated with leukotriene inhibitors within 4 weeks;&#xD;
  &#xD;
                 5. Treated with topical preparations of TCS or TCI or phosphodiesterase 4 (PDE⁃4)&#xD;
                    inhibitors within 2 weeks;&#xD;
  &#xD;
                 6. Treatment with the following biologics: any cell depleting agent, including but&#xD;
                    not limited to rituximab: within 6 months or until the lymphocyte count returns&#xD;
                    to normal, whichever is longer; Other biologics: 5 half-lives (if half-life&#xD;
                    known) or 12 weeks (whichever is longer); Within 4 weeks, receive regular&#xD;
                    phototherapy (including but not limited to narrow-spectrum UVB, psoralen longwave&#xD;
                    ultraviolet therapy, etc.) or use artificial sunbathing sheds/rooms;&#xD;
  &#xD;
                 7. Within 12 weeks, receive live (attenuated) vaccine;&#xD;
  &#xD;
                 8. Chronic active or acute infection requiring systemic treatment with antibiotics,&#xD;
                    antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks, or&#xD;
                    superficial skin infection within 1 week prior to baseline visit. After the&#xD;
                    infection resolves, screening can be renewed;&#xD;
  &#xD;
                 9. Antihistamines (including oral, nasal, and topical preparations) within 1 week;&#xD;
  &#xD;
            -  Abnormal physical examination results during screening or any of the following&#xD;
               laboratory tests:&#xD;
  &#xD;
                 1. Hemoglobin&lt; 110 g/L&#xD;
  &#xD;
                 2. White blood cell (WBC) &lt; 3.5 x 10^9/L&#xD;
  &#xD;
                 3. Platelet count &lt; 125 x 10^9/L&#xD;
  &#xD;
                 4. Neutrophils&lt; 1.75 x 10^9/L • Aspartate aminotransferase (AST)/alanine&#xD;
                    aminotransferase (ALT) &gt;1.5 x upper limit of normal (ULN)&#xD;
  &#xD;
                 5. Total bilirubin &gt; 1.5 x ULN (except indirect bilirubin elevation secondary to&#xD;
                    Gilbert syndrome)&#xD;
  &#xD;
                 6. Creatinine &gt; 1.5 x ULN&#xD;
  &#xD;
                 7. Creatine phosphokinase (CPK) &gt; 2 x ULN&#xD;
  &#xD;
            -  There are cutaneous comorbidities that may interfere with the study assessment,&#xD;
               including but not limited to scabies, seborrheic dermatitis, cutaneous T-cell&#xD;
               lymphoma, psoriasis, etc&#xD;
  &#xD;
            -  Concomitant other serious medical conditions that, at the discretion of the&#xD;
               investigator, may adversely affect participants' participation in this study,&#xD;
               including, but not limited to: short life expectancy, history of uncontrolled diabetes&#xD;
               (HbA1c ≥ 9%), cardiovascular disease (eg, grade III or IV heart failure, graded&#xD;
               according to the New York Heart Association), severe kidney disease (eg, patients on&#xD;
               dialysis), hepatobiliary disease (e.g., Child-Pugh class B or C), neurological disease&#xD;
               (e.g., demyelinating disease), Patients with important active autoimmune diseases (eg,&#xD;
               lupus, inflammatory bowel disease, rheumatoid arthritis, etc.), as well as other&#xD;
               severe endocrine, gastrointestinal, metabolic, pulmonary, or lymphatic diseases.&#xD;
  &#xD;
            -  Have a history of known or suspected immunosuppression, including invasive&#xD;
               opportunistic infections (e.g., histoplasmosis, listeriosis, coccidioidomycosis,&#xD;
               pneumocystosis, and aspergillosis), even if the infection has resolved; or unusual&#xD;
               frequent, recurrent, or long-term infections (at the investigator's discretion);&#xD;
  &#xD;
            -  Subjects with any type of active malignancy or a history of malignancy (except&#xD;
               cervical cancer or non-metastatic cutaneous squamous cell carcinoma, basal cell&#xD;
               carcinoma and papillary thyroid carcinoma) that has been cured for more than 5 years&#xD;
               prior to the screening period;&#xD;
  &#xD;
            -  Computed Tomography (CT) of the chest shows active or occult tuberculosis or a history&#xD;
               of contact with an open tuberculosis (TB) subject within the past 6 months. If the&#xD;
               laboratory T cell spot test for tuberculosis infection test (or other tuberculosis&#xD;
               diagnostic test) is positive, its activity is judged in combination with the medical&#xD;
               history, clinical manifestations, etc., and the investigator determines whether it can&#xD;
               be enrolled;&#xD;
  &#xD;
            -  Active hepatitis during the screening period, or positive for hepatitis B surface&#xD;
               antigen (HBsAg), or positive for hepatitis B core antibody (HBcAb);&#xD;
  &#xD;
            -  History of human immunodeficiency virus (HIV) infection, or positive HIV serological&#xD;
               results at screening, and positive antibodies to treponema pallidum during screening&#xD;
  &#xD;
            -  Positive for treponemal pallidum antibodies during screening&#xD;
  &#xD;
            -  Parasitic infection related to any of the following is excluded:&#xD;
  &#xD;
                 1. Routine inspection of worm eggs during the screening period;&#xD;
  &#xD;
                 2. History of parasitic infection within 6 months prior to the screening period,&#xD;
                    except for cured trichomoniasis;&#xD;
  &#xD;
            -  Have participated in clinical trials of other drugs or medical devices within 12 weeks&#xD;
               prior to screening&#xD;
  &#xD;
            -  During the period of participation in this study, participants had planned surgical&#xD;
               procedures&#xD;
  &#xD;
            -  Pregnant or lactating women&#xD;
  &#xD;
            -  People who are alcoholic, drug addicts, and known drug dependents&#xD;
  &#xD;
            -  In the judgment of the investigator or sponsoring medical auditor, it is believed that&#xD;
               there are any medical or psychiatric symptoms that put the subject at risk, interfere&#xD;
               with participation in the study, or interfere with the interpretation of the results&#xD;
               of the study.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Qian-jin Lu, Doctor</last_name>
      <phone>+86 13787097676</phone>
      <email>qianlu5860@gmail.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>The First Affiliated Hospital of Wannan Medical College</name>
        <address>
          <city>Wuhu</city>
          <state>Anhui</state>
          <zip>241000</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Chao Ci, Bachelor</last_name>
        <phone>+86 13956218911</phone>
        <email>cichao8911@126.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Dermatology Hospital, Southern Medical University</name>
        <address>
          <city>Guangzhou</city>
          <state>Guangdong</state>
          <zip>510030</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Bin Yang, Doctor</last_name>
        <phone>+86 13922207231</phone>
        <email>yangbin101@hotmail.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>The Second Affiliated Hospital of Guangzhou Medical University</name>
        <address>
          <city>Guangzhou</city>
          <state>Guangdong</state>
          <zip>510260</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Wenlin Yang, Master</last_name>
        <phone>+86 18122256635</phone>
        <email>yangwenlin@21cn.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>Recruiting</status>
      <contact>
        <last_name>Jianglin Zhang, Doctor</last_name>
        <phone>+86 13873143466</phone>
        <email>jianglin@szhospital.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Affiliated Hospital of Guilin Medical University</name>
        <address>
          <city>Guilin</city>
          <state>Guangxi</state>
          <zip>541001</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Xi Huang, Master</last_name>
        <phone>+86 13907731329</phone>
        <email>1352215665@qq.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Affiliated Hospital of Hebei Engineering University</name>
        <address>
          <city>Handan</city>
          <state>Hebei</state>
          <zip>056002</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Guoying Miao, Master</last_name>
        <phone>+86 18031028050</phone>
        <email>guoyingmiao_hgdfs@163.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>The Forth Hospital of Hebei Medical University</name>
        <address>
          <city>Shijiazhuang</city>
          <state>Hebei</state>
          <zip>050000</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Wenqing Wang, Doctor</last_name>
        <phone>+86 15831948173</phone>
        <email>wangwqlcsy@163.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>The second affiliated hospital of harbin medical university</name>
        <address>
          <city>Harbin</city>
          <state>Heilongjiang</state>
          <zip>150000</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Yuzhen Li, Doctor</last_name>
        <phone>+86 13936367628</phone>
        <email>liyuzhenyidaeryuan@126.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Puyang District Hospital of Anyang City</name>
        <address>
          <city>Anyang</city>
          <state>Henan</state>
          <zip>455000</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Xiaohan Wang, Bachelor</last_name>
        <phone>+86 13569009795</phone>
        <email>wangxiaohan11@hotmail.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>The First People's Hospital of Nanyang</name>
        <address>
          <city>Nanyang</city>
          <state>Henan</state>
          <zip>473000</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Rixin Chen, Master</last_name>
        <phone>+86 13849795170</phone>
        <email>pfkgcpby@163.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>People's Hospital of Henan province</name>
        <address>
          <city>Zhengzhou</city>
          <state>Henan</state>
          <zip>450003</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Shoumin Zhang, Master</last_name>
        <phone>+86 13937168956</phone>
        <email>1264100668@qq.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Shiyan Renmin Hospital</name>
        <address>
          <city>Shiyan</city>
          <state>Hubei</state>
          <zip>442000</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Zudong Meng, Master</last_name>
        <phone>+86 13997837543</phone>
        <email>1970547910@qq.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Renmin Hospital of Wuhan University</name>
        <address>
          <city>Wuhan</city>
          <state>Hubei</state>
          <zip>430000</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Tiechi Lei, Doctor</last_name>
        <phone>+86 15337173507</phone>
        <email>tiechilei@126.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>The third xiangya hospital of central south university</name>
        <address>
          <city>Changsha</city>
          <state>Hunan</state>
          <zip>410013</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Jianyun Lu, Doctor</last_name>
        <phone>+86 13975130008</phone>
        <email>lujianyun888@163.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Qian-jin Lu</name>
        <address>
          <city>Nanjing</city>
          <state>Jiangsu</state>
          <zip>210042</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Qian-jin Lu, Doctor</last_name>
        <phone>+86 13787097676</phone>
        <email>qianlu5860@gmail.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Affiliated Hospital of Jiujiang University</name>
        <address>
          <city>Jiujiang</city>
          <state>Jiangxi</state>
          <zip>332000</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Qiuhe Song, Doctor</last_name>
        <phone>+86 15079249301</phone>
        <email>787278405@qq.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>The Second Hospital of Jilin University</name>
        <address>
          <city>Changchun</city>
          <state>Jilin</state>
          <zip>130041</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Fuqiu Li, Doctor</last_name>
        <phone>+86 13039123758</phone>
        <email>Lifuqiu1234@126.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Panjin Liaoyou Gem Flower Hospital</name>
        <address>
          <city>Panjin</city>
          <state>Liaoning</state>
          <zip>124000</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Yingxia He, Bachelor</last_name>
        <phone>+86 13904273211</phone>
        <email>3155721826@qq.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>The First Affiliated Hospital of China Medical University</name>
        <address>
          <city>Shenyang</city>
          <state>Liaoning</state>
          <zip>110000</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Li Zhang, Doctor</last_name>
        <phone>+86 13940023570</phone>
        <email>lizhang_1001@126.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Air Force Medical University</name>
        <address>
          <city>Xi'an</city>
          <state>Shaanxi</state>
          <zip>710032</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Chen Yu, Doctor</last_name>
        <phone>+86 13571991903</phone>
        <email>13571991903@163.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>The Second Affiliated Hospital of Xi'an Jiaotong University</name>
        <address>
          <city>Xi'an</city>
          <state>Shaanxi</state>
          <zip>710061</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Songmei Geng, Doctor</last_name>
        <phone>+86 13060423612</phone>
        <email>gsm312@yahoo.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Shengli Oil Field Central Hospital</name>
        <address>
          <city>Dongying</city>
          <state>Shandong</state>
          <zip>25700</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Min Yan, bachelor</last_name>
        <phone>+86 18661399259</phone>
        <email>18661399259@163.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Shandong First Medical University Affiliated Dermatology Hospital</name>
        <address>
          <city>Jinan</city>
          <state>Shandong</state>
          <zip>250022</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Furen Zhang, Doctor</last_name>
        <phone>+86 13608921718</phone>
        <email>zhangfurenlcsy@163.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Qilu Hospital of Shandong University</name>
        <address>
          <city>Jinan</city>
          <state>Shandong</state>
          <zip>250063</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Qing Sun, Doctor</last_name>
        <phone>+86 18560082626</phone>
        <email>sunqing7226@163.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>The Affiliated Hospital Of Qingdao University</name>
        <address>
          <city>Qingdao</city>
          <state>Shandong</state>
          <zip>266000</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Guanzhi Chen, Master</last_name>
        <phone>+86 18661807667</phone>
        <email>Chenguanzhiqd@126.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Huashan Hospital Affiliated to Fudan University</name>
        <address>
          <city>Shanghai</city>
          <state>Shanghai</state>
          <zip>200040</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Wei Li, Doctor</last_name>
        <phone>+86 18629352992</phone>
        <email>liweiderma@163.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital</name>
        <address>
          <city>Tianjin</city>
          <state>Tianjin</state>
          <zip>300122</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Litao Zhang, Doctor</last_name>
        <phone>18602228122</phone>
        <email>zhanglitao@medmail.com.cn</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Xinjiang Uygur Autonomous Region People's Hospital</name>
        <address>
          <city>Ürümqi</city>
          <state>Xinjiang Uygur Autonomous Region</state>
          <zip>830000</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Xiaojing Kang, Doctor</last_name>
        <phone>+86 13999927999</phone>
        <email>postmaster@xjrmyy.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>The First Affiliated Hospital of Kunming Medical University</name>
        <address>
          <city>Kunming</city>
          <state>Yunnan</state>
          <zip>650000</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Li He, Doctor</last_name>
        <phone>+86 13577098206</phone>
        <email>drheli2662@126.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>The First Affiliated Hospital, Zhejiang University School of Medicine</name>
        <address>
          <city>Hangzhou</city>
          <state>Zhejiang</state>
          <zip>310003</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Jianjun Qiao, Doctor</last_name>
        <phone>+86 13735542393</phone>
        <email>qiaojianjun@126.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>The Second Affiliated Hospital Zhejiang University School of Medicine</name>
        <address>
          <city>Hangzhou</city>
          <state>Zhejiang</state>
          <zip>310009</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Xiao Yong Man, Doctor</last_name>
        <phone>+86 13600516219</phone>
        <email>manxy@zju.edu.cn</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>The First People's Hospital of Wenling</name>
        <address>
          <city>Wenling</city>
          <state>Zhejiang</state>
          <zip>317500</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Hongxia Feng, Master</last_name>
        <phone>+86 18648475920</phone>
        <email>fenghongxia0472@163.com</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>March 2023</verification_date>
    <study_first_submitted>July 24, 2023</study_first_submitted>
    <study_first_submitted_qc>July 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>July 31, 2023</last_update_submitted>
    <last_update_submitted_qc>July 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 1, 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>Dermatitis, Atopic</mesh_term>
      <mesh_term>Dermatitis</mesh_term>
      <mesh_term>Eczema</mesh_term>
    </condition_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/NCT05970432
  org study id: TQH2722-II-01
  nct id: NCT05970432
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  This phase II clinical trials is multicenter, randomized, double-blind, placebo-controlled to
        assess the effectiveness and safety of TQH2722 injection in the treatment of subjects with
        moderate to severe atopic dermatitis.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  measure: Eczema area and severity (EASI)-75 (≥75% improvement from baseline).
  time frame: Up to 16 weeks.
  description: Proportion of participants with eczema area and severity (EASI)-75 (≥75% improvement from baseline) at week 16.
  measure: Investigator's general assessment (IGA)
  time frame: Up to 16 weeks.
  description: Proportion of subjects with, the investigator's overall assessment (IGA) of 0 or 1 (6-point in total) at week 16.
  measure: Eczema area and severity (EASI)-90 (≥90% improvement from baseline).
  time frame: Up to 16 weeks.
  description: Proportion of participants with EASI-90 at week 16.
  measure: Eczema area and severity (EASI)
  time frame: Up to 16 weeks.
  description: Percentage change in EASI score from baseline to week 16;
  measure: Change in investigator's general assessment (IGA)
  time frame: Up to 16 weeks.
  description: Change (or percentage change) in IGA score from baseline to week 16;
  measure: Body surface area (%BSA)
  time frame: Up to 16 weeks.
  description: %BSA change from baseline to week 16
  measure: Treatment Emergent Adverse Events (TEAE)
  time frame: Up to 20 weeks.
  description: Incidence of TEAE from baseline to week 20 determined by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTC AE) V5.0.
  measure: Incidence of anti-drug antibodies (ADAs)
  time frame: Up to 24 weeks.
  description: The incidence of anti-drug antibodies (ADAs) of subjects and their titer, the incidence of neutralizing antibodies (Nab). If the subject is tested positive for ADA, a neutralizing antibody is added in the test.
  measure: Incidence of neutralizing antibodies
  time frame: Up to 24 weeks.
  description: If the subject is tested positive for ADA, a neutralizing antibody is added.
  measure: Peak Itch numerical rating scale (NRS)
  time frame: Up to 16 weeks.
  description: Peak Itch NRS changes from baseline to week 16. The total score is 10, with higher scores indicating more severe pruritus.
  measure: Dermatology Life Quality Index (DLQI) scores
  time frame: Up to 16 weeks.
  description: DLQI scores change from baseline to week 16, the scores are rated as None, Not Relevant, and 0-3, with higher values representing more serious disease.
  arm group label: TQH2722 injection 300mg-150mg
  arm group type: Experimental
  description: Participants received subcutaneous injection of 300 mg TQH2722 injection + 600 mg placebo on day 1, followed by subcutaneous injection of 150 mg TQH2722 injection + 300 mg placebo on days 15, 29, 43, 57, 71, 85, 99.
  arm group label: TQH2722 injection 600mg-300mg
  arm group type: Experimental
  description: Participants received subcutaneous injection of 600 mg TQH2722 injection + 300 mg placebo on day 1, followed by subcutaneous injection of 300 mg TQH2722 injection + 150 mg placebo on days 15, 29, 43, 57, 71, 85, 99.
  arm group label: TQH2722 injection 900mg-450mg
  arm group type: Experimental
  description: Participants received subcutaneous injection of 900 mg TQH2722 injection on day 1, followed by subcutaneous injection of 450 mg TQH2722 injection on days 15, 29, 43, 57, 71, 85, 99.
  arm group label: TQH2722 injection matching Placebo
  arm group type: Placebo Comparator
  description: Subjects received 900mg placebo injection subcutaneously on day 1, followed by 450mg placebo injection on days 15, 29, 43, 57, 71, 85, 99.
  intervention type: Drug
  intervention name: TQH2722 injection 300mg-150mg
  description: TQH2722 injection is a fully human monoclonal antibody that interfering with the signal cascade.
  arm group label: TQH2722 injection 300mg-150mg
  intervention type: Drug
  intervention name: TQH2722 injection 600mg-300mg
  description: TQH2722 injection is a fully human monoclonal antibody that thereby interfering with the signal cascade.
  arm group label: TQH2722 injection 600mg-300mg
  intervention type: Drug
  intervention name: TQH2722 injection 900mg-450mg
  description: TQH2722 injection is a fully human monoclonal antibody that thereby interfering with the signal cascade.
  arm group label: TQH2722 injection 900mg-450mg
  intervention type: Drug
  intervention name: TQH2722 injection matching Placebo
  description: Placebo without active substance.
  arm group label: TQH2722 injection matching Placebo
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: No
  last name: Qian-jin Lu, Doctor
  phone: +86 13787097676
  email: qianlu5860@gmail.com
  facility: 
  status: Recruiting
  contact: 
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  status: Recruiting
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  status: Recruiting
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  status: Recruiting
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  status: Recruiting
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  status: Recruiting
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  status: Recruiting
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  status: Recruiting
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  status: Recruiting
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  status: Recruiting
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  status: Recruiting
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  status: Recruiting
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  status: Recruiting
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  status: Recruiting
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  status: Recruiting
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  status: Recruiting
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  status: Recruiting
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  status: Recruiting
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  status: Recruiting
  contact: 
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  status: Recruiting
  contact: 
  country: China
  responsible party type: Sponsor
  mesh term: Dermatitis, Atopic
  mesh term: Dermatitis
  mesh term: Eczema