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/NCT06036927</url>
    </required_header>
    <id_info>
      <org_study_id>TQC2731-II-02</org_study_id>
      <nct_id>NCT06036927</nct_id>
    </id_info>
    <brief_title>A Clinical Study of TQC2731 Injection in the Treatment of Chronic Rhinosinusitis With Nasal Polyps</brief_title>
    <official_title>A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Clinical Trial to Evaluate the Efficacy, Safety and Pharmacokinetics of TQC2731 Injection in the Treatment of Chronic Sinusitis With Nasal Polyps.</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 is a multicenter, randomized, double-blind, placebo-controlled Phase II clinical trial&#xD;
        to evaluate the efficacy, safety and pharmacokinetics of TQC2731 injection in the treatment&#xD;
        of Chronic Sinusitis with Nasal Polyps.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 2023</start_date>
    <completion_date type="Anticipated">September 2025</completion_date>
    <primary_completion_date type="Anticipated">July 2025</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>Nasal Polyp Score (NPS)</measure>
      <time_frame>Baseline up to 24 weeks</time_frame>
      <description>NPS is the sum of the left and right nostril scores evaluated through nasal endoscopy, with a total score range of 0 to 8. NPS is based on polyp grading, with a score of 0-4 based on polyp grading.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Nasal congestion score (NCS)</measure>
      <time_frame>Baseline up to 24 weeks</time_frame>
      <description>NCS is determined by the subjects based on the severity of the nasal congestion in the past 24 hours. This score uses a 0-3 classification scale, where 0=no symptoms, 1=mild symptoms, 2=moderate symptoms, and 3=severe symptoms.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Anosmia Score</measure>
      <time_frame>Baseline up to 24 weeks</time_frame>
      <description>Anosmia Score is evaluated by subjects based on their severity of Anosmia on the day. This score uses a 0-3 classification scale, where 0=no symptoms, 1=mild symptoms, 2=moderate symptoms, and 3=severe symptoms.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Total symptom score (TSS)</measure>
      <time_frame>Baseline up to 24 weeks</time_frame>
      <description>TSS is the sum of nasal congestion, anosmia, and rhinorrhea (the average of anterior and posterior rhinorrhea), with a score range of 0-9 points. The severity is evaluated by the subject and recorded on the subject diary record card.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Visual analogue scale (VAS) for sinusitis</measure>
      <time_frame>Baseline up to 24 weeks</time_frame>
      <description>VAS for sinusitis is a questionnaire that subjective evaluation of the overall severity of sinusitis by subjects, with a score range of 0-10 points. The higher the score, the greater the impact of sinusitis on the quality of life of the subjects.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Nasal polyp (NP) surgery time</measure>
      <time_frame>Baseline up to 32 weeks</time_frame>
      <description>Time to the first nasal polyp (NP) surgery of subjects</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Nasal polyp (NP) surgery ratio</measure>
      <time_frame>Baseline up to 32 weeks</time_frame>
      <description>Ratio of subjects who undergo nasal polyp surgery.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time of Systemic glucocorticoids (SCS) remedial treatment</measure>
      <time_frame>Baseline up to 32 weeks</time_frame>
      <description>Time to first use of systemic glucocorticoids (SCS) as remedial treatment of subjects.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Ratio of Systemic glucocorticoids (SCS) treatment</measure>
      <time_frame>Baseline up to 32 weeks</time_frame>
      <description>Ratio of subjects who using SCS as remedial treatment.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Lund Mackay (LMK) score</measure>
      <time_frame>Baseline up to 24 weeks</time_frame>
      <description>The LMK score is based on the results of sinus Computed Tomography (CT) scans. Evaluated by researchers, divided into left and right sinus systems, with 0-12 points per side and a total score of 0-24 points.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence of Adverse event (AE)</measure>
      <time_frame>Baseline up to 32 weeks</time_frame>
      <description>Incidence of AE, serious adverse event (SAE) and abnormal laboratory tests</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Severity of AE</measure>
      <time_frame>Baseline up to 32 weeks</time_frame>
      <description>Severity of AE, serious adverse event (SAE) and abnormal laboratory tests</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Peak concentration (Cmax)</measure>
      <time_frame>Before first administration, 1, 4, 8, 12, 24, 72, 120, 144, 168, 336 hours after first administration; before second, third, fourth and last administration; 1, 4, 8, 12, 24, 72, 168, 336, 672, 1008, 1344, 1992 hours after last administration.</time_frame>
      <description>Maximum plasma drug concentration</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Trough concentration (Cmin)</measure>
      <time_frame>Before first administration, 1, 4, 8, 12, 24, 72, 120, 144, 168, 336 hours after first administration; before second, third, fourth and last administration; 1, 4, 8, 12, 24, 72, 168, 336, 672, 1008, 1344, 1992 hours after last administration.</time_frame>
      <description>Minimum plasma drug concentration</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time to Peak concentration (Tmax)</measure>
      <time_frame>Before first administration, 1, 4, 8, 12, 24, 72, 120, 144, 168, 336 hours after first administration; before second, third, fourth and last administration; 1, 4, 8, 12, 24, 72, 168, 336, 672, 1008, 1344, 1992 hours after last administration.</time_frame>
      <description>The time when reach maximum plasma drug concentration</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Area under the concentration time curve (AUC0-t)</measure>
      <time_frame>Before first administration, 1, 4, 8, 12, 24, 72, 120, 144, 168, 336 hours after first administration; before second, third, fourth and last administration; 1, 4, 8, 12, 24, 72, 168, 336, 672, 1008, 1344, 1992 hours after last administration.</time_frame>
      <description>The area enclosed by the plasma concentration curve to the timeline</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Maximum plasma concentration at steady state (Css-max)</measure>
      <time_frame>Before first administration, 1, 4, 8, 12, 24, 72, 120, 144, 168, 336 hours after first administration; before second, third, fourth and last administration; 1, 4, 8, 12, 24, 72, 168, 336, 672, 1008, 1344, 1992 hours after last administration.</time_frame>
      <description>The maximum plasma concentration after stabilization</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Minimum plasma concentration at steady state (Css-min)</measure>
      <time_frame>Before first administration, 1, 4, 8, 12, 24, 72, 120, 144, 168, 336 hours after first administration; before second, third, fourth and last administration; 1, 4, 8, 12, 24, 72, 168, 336, 672, 1008, 1344, 1992 hours after last administration.</time_frame>
      <description>The minimum plasma concentration after stabilization</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Plasma concentration at steady state (Css-av)</measure>
      <time_frame>Before first administration, 1, 4, 8, 12, 24, 72, 120, 144, 168, 336 hours after first administration; before second, third, fourth and last administration; 1, 4, 8, 12, 24, 72, 168, 336, 672, 1008, 1344, 1992 hours after last administration.</time_frame>
      <description>The plasma concentration at which the rate of administration and rate of elimination are in equilibrium.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time to Peak concentration at steady state (Tss-max)</measure>
      <time_frame>Before first administration, 1, 4, 8, 12, 24, 72, 120, 144, 168, 336 hours after first administration; before second, third, fourth and last administration; 1, 4, 8, 12, 24, 72, 168, 336, 672, 1008, 1344, 1992 hours after last administration.</time_frame>
      <description>The time when maximum plasma drug concentration at steady state.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Area under the concentration time curve (AUC0-t) at steady state</measure>
      <time_frame>Before first administration, 1, 4, 8, 12, 24, 72, 120, 144, 168, 336 hours after first administration; before second, third, fourth and last administration; 1, 4, 8, 12, 24, 72, 168, 336, 672, 1008, 1344, 1992 hours after last administration.</time_frame>
      <description>The area enclosed by the plasma concentration curve to the timeline at steady state.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Half life (t1/2)</measure>
      <time_frame>Before first administration, 1, 4, 8, 12, 24, 72, 120, 144, 168, 336 hours after first administration; before second, third, fourth and last administration; 1, 4, 8, 12, 24, 72, 168, 336, 672, 1008, 1344, 1992 hours after last administration.</time_frame>
      <description>The time taken for the plasma concentration to be reduced by half.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Apparent volume distribution (Vd/F)</measure>
      <time_frame>Before first administration, 1, 4, 8, 12, 24, 72, 120, 144, 168, 336 hours after first administration; before second, third, fourth and last administration; 1, 4, 8, 12, 24, 72, 168, 336, 672, 1008, 1344, 1992 hours after last administration.</time_frame>
      <description>It refers to the ratio between the body drug amount and the blood drug concentration after the drug has reached dynamic equilibrium in the body.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Plasma clearance (CL/F)</measure>
      <time_frame>Before first administration, 1, 4, 8, 12, 24, 72, 120, 144, 168, 336 hours after first administration; before second, third, fourth and last administration; 1, 4, 8, 12, 24, 72, 168, 336, 672, 1008, 1344, 1992 hours after last administration.</time_frame>
      <description>The volume of plasma cleared of drug per unit time.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Anti-drug antibody (ADA)</measure>
      <time_frame>Within 1 hour before administration on Day 1, Day 169, Day 224, during withdrawal</time_frame>
      <description>Incidence and their titers of Anti-drug antibody (ADA)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Neutralizing antibody (Nab)</measure>
      <time_frame>Within 1 hour before administration on Day 1, Day 169, Day 224, during withdrawal</time_frame>
      <description>Incidence and their titers of Neutralizing antibody (Nab)</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">80</enrollment>
    <condition>Chronic Sinusitis</condition>
    <condition>Nasal Polyps</condition>
    <arm_group>
      <arm_group_label>TQC2731 injection 210 mg</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>TQC2731 injection 210 mg combined with Mometasone Furoate Aqueous Nasal Spray, 28 days as a treatment cycle.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>TQC2731 injection 420 mg</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>TQC2731 injection 420 mg combined with Mometasone Furoate Aqueous Nasal Spray, 28 days as a treatment cycle.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>TQC2731 matching placebo</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>TQC2731 matching placebo combined with Mometasone Furoate Aqueous Nasal Spray, 28 days as a treatment cycle.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>TQC2731 injection</intervention_name>
      <description>TQC2731 injection is a thymic stromal lymphopoietin (TSLP) monoclonal antibody.</description>
      <arm_group_label>TQC2731 injection 210 mg</arm_group_label>
      <arm_group_label>TQC2731 injection 420 mg</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>TQC2731 matching placebo</intervention_name>
      <description>It'a a placebo injection without active substances.</description>
      <arm_group_label>TQC2731 matching placebo</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Subjects sign informed consent before study, fully understand the purpose, procedures&#xD;
               and possible adverse reactions of the study;&#xD;
  &#xD;
            -  Male and female, ≥18 years old and ≤ 75 years old;&#xD;
  &#xD;
            -  Bilateral chronic rhinosinusitis with nasal polyps (CRSwNP) who met the diagnostic&#xD;
               criteria of the Chinese Guidelines for the Diagnosis and Treatment of chronic&#xD;
               rhinosinusitis (2018);&#xD;
  &#xD;
            -  Received nasal polyp surgery or received systemic glucocorticoid treatment 2 years&#xD;
               before screening;&#xD;
  &#xD;
            -  Bilateral nasal polyp score (NPS) ≥5 and each nostril was scored ≥ 2 when screening&#xD;
               and randomization;&#xD;
  &#xD;
            -  Nasal congestion score (NCS) ≥2 when screening and randomization;&#xD;
  &#xD;
            -  Persistent nasal leakage or smell decrease or loss last more than 8 weeks before&#xD;
               screening;&#xD;
  &#xD;
            -  Sinonasal outcome testing 22 (SNOT-22) score ≥ 30 when screening and randomization;&#xD;
  &#xD;
            -  Subjects received steady dose of intranasal glucocorticoids (INCS) over 4 weeks before&#xD;
               screening (subjects agree use Mometasone Furoate Aqueous Nasal Spray (MFNS) while&#xD;
               studying);&#xD;
  &#xD;
            -  Subjects with asthma start inhaled stable dose of glucocorticoid therapy over 4 weeks&#xD;
               before screening, and are willing to keep the dose during whole study;&#xD;
  &#xD;
            -  MFNS medication compliance ≥70%, subjects daily symptom assessment compliance ≥70%&#xD;
               through Patient dairy;&#xD;
  &#xD;
            -  Subjects agree to take effective non-pharmaceutical contraception from signing&#xD;
               informed consent to 6 mouth after last administration.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Presence of conditions/concomitant diseases that affect the evaluation of efficacy,&#xD;
               such as:&#xD;
  &#xD;
                 1. Posterior nostril polyps;&#xD;
  &#xD;
                 2. Deviation of the nasal septum resulted in obstruction of at least one nostril;&#xD;
  &#xD;
                 3. Acute sinusitis, nasal infection, or upper respiratory tract infection had&#xD;
                    occurred 2 weeks before screening, screening period or mediation period;&#xD;
  &#xD;
                 4. Drug induced rhinitis;&#xD;
  &#xD;
                 5. Allergic granulomatous vasculitis (Churg-Strauss syndrome), granuloma with poly&#xD;
                    vasculitis (Wegener's granuloma), Young syndrome, Kartagener syndrome, or other&#xD;
                    dysphoric ciliary syndrome, with cystic fibrosis;&#xD;
  &#xD;
                 6. Imaging suspected or confirmed fungal sinusitis;&#xD;
  &#xD;
                 7. NPS cannot be evaluated due to nasal surgery to alter the structure of the&#xD;
                    lateral nasal wall;&#xD;
  &#xD;
                 8. Subjects with nasal malignancies and benign tumors (papilloma, blood furuncle,&#xD;
                    etc.)&#xD;
  &#xD;
            -  Any type of active malignancy or a history of malignancy (Patient with basal cell&#xD;
               carcinoma, skin localized squamous cell carcinoma or carcinoma in situ of cervix, can&#xD;
               participate in the study if curative treatment was completed for more than 12 months&#xD;
               prior to visit 1; Patients with other malignant tumors can participate in the study if&#xD;
               curative therapy had been completed for at least 5 years prior to visit 1);&#xD;
  &#xD;
            -  Active autoimmune disease (including but not limited to Hashimoto's thyroiditis,&#xD;
               Graves disease, Inflammatory bowel disease, Primary biliary cholangitis, Systemic&#xD;
               lupus erythematosus, Multiple sclerosis and other neuroinflammatory diseases,&#xD;
               Psoriasis vulgaris, Rheumatoid arthritis);&#xD;
  &#xD;
            -  Known or suspected history of immunosuppression, immune disorders, or immune&#xD;
               disorders, including but not limited to invasive opportunistic infections&#xD;
               (histoplasmosis, listeriosis, coccidioides, pulmonary cysticercosis disease,&#xD;
               aspergillosis), even if the infection has been resolved;&#xD;
  &#xD;
            -  Any intranasal and/or sinus surgery (including polypectomy) within 6 months before&#xD;
               screening;&#xD;
  &#xD;
            -  Uncontrolled epistaxis occurred within 2 months before screening;&#xD;
  &#xD;
            -  A history of active pulmonary tuberculosis in the 12 months before screening;&#xD;
  &#xD;
            -  Infection requiring treatment with systemic antibacterial, antiviral, antifungal,&#xD;
               antiparasitic, or antiparasitic agents occurred within 14 days before screening;&#xD;
  &#xD;
            -  Helminth parasite infection was diagnosed within 24 weeks prior to screening and had&#xD;
               not received or failed to respond to standard treatment;&#xD;
  &#xD;
            -  Leukotriene antagonists/modulators were used while screening (using a stable dose of&#xD;
               leukotriene modulator for ≥30 days before screening was acceptable);&#xD;
  &#xD;
            -  Regular use of decongestants (topical or systemic) before screening, except for&#xD;
               short-term use for endoscopy;&#xD;
  &#xD;
            -  Patients who received any of the following treatments before screening:&#xD;
  &#xD;
                 1. Received immunosuppressive therapy within the previous 8 weeks or five half-lives&#xD;
                    (whichever was longer), (including but not limited to cyclophosphamide,&#xD;
                    cyclosporine, interferon-γ, azathioprine, methotrexate, mycophenolate mofetil and&#xD;
                    tacrolimus, etc.);&#xD;
  &#xD;
                 2. Received monoclonal antibody therapy within the previous 8 weeks or five&#xD;
                    half-lives (whichever was longer), (Including but not limited to: benralizumab,&#xD;
                    mepolizumab, omalizumab, resveratrol, dupilumab, etc.);&#xD;
  &#xD;
                 3. Received systemic glucocorticoids within 28 days before the study;&#xD;
  &#xD;
                 4. Glucocorticoid-eluting nasal stents were used within 6 months before the study;&#xD;
  &#xD;
                 5. Immune globulin or blood products therapy were used within 28 days before the&#xD;
                    study;&#xD;
  &#xD;
                 6. Received or planned to receive live attenuated vaccine within 28 days before or&#xD;
                    during the study period;&#xD;
  &#xD;
                 7. Received allergen specific immunotherapy 6 mouth before screening (if started at&#xD;
                    3 mouth before screening, being treated at a stable dose in 1 mouth before visit&#xD;
                    1 and not expected to change during study, it would be acceptable);&#xD;
  &#xD;
                 8. Join any other clinical trials within 3 months;&#xD;
  &#xD;
            -  Patients with concurrent asthma had any of the following conditions: forced expiratory&#xD;
               volume in the first second (FEV1) ≤ 50% of the expected normal value, or acute&#xD;
               exacerbation of asthma within 90 days prior to screening, requiring hospitalization&#xD;
               (&gt;24 hours), or taking a daily dose greater than 1000 μg of fluticasone or equivalent&#xD;
               inhaled glucocorticoids (ICS);&#xD;
  &#xD;
            -  Hepatitis B surface Antigen (HBsAg) positive, or Hepatitis B core antibody (HBcAb)&#xD;
               positive and Hepatitis B virus deoxyribonucleic acid (HBV-DNA) positive, or&#xD;
               anti-hepatitis C virus (Anti-HCV) positive and Hepatitis C virus ribonucleic acid&#xD;
               (HCV-RNA) positive, or anti-human Immunodeficiency Virus (Anti-HIV) positive, or&#xD;
               anti-treponema pallidum (Anti-TP) positive;&#xD;
  &#xD;
            -  Any clinically significant abnormal findings, include physical examination, vital&#xD;
               signs, 12-lead electrocardiogram, blood biochemistry, blood routine or urine routine,&#xD;
               and investigator judged that participating in the trial may put the patient at risk,&#xD;
               or may affect the study outcome or hinder the patient's ability to complete the entire&#xD;
               study process;&#xD;
  &#xD;
            -  Lab tests results were abnormal:&#xD;
  &#xD;
                 1. White cell count&lt;3.5 x 10^9/L;&#xD;
  &#xD;
                 2. Aspartate aminotransferase (AST) &gt; 2.5 x upper limits of normal (ULN);&#xD;
  &#xD;
                 3. Alanine aminotransferase (ALT) &gt; 2.5 x ULN;&#xD;
  &#xD;
                 4. Total bilirubin &gt; 2 x ULN;&#xD;
  &#xD;
                 5. Creatine phosphokinase (CPK)&gt; 2 x ULN;&#xD;
  &#xD;
                 6. Creatinine &gt;1.5 x ULN&#xD;
  &#xD;
            -  Pregnant or lactating women;&#xD;
  &#xD;
            -  A allergic history or allergic reaction to Mometasone furoate nasal spray (Nasonex®)&#xD;
               or any component of TQC2731 injection;&#xD;
  &#xD;
            -  A history of systemic allergy to any biologic drug (except local injection site&#xD;
               reactions);&#xD;
  &#xD;
            -  The subjects had poor compliance and were judged unable to complete the study;&#xD;
  &#xD;
            -  Any medical or psychiatric disorder that was considered by the investigator or the&#xD;
               sponsor medical reviewer to be likely to affect the safety of the subjects throughout&#xD;
               the study or to prevent the subjects from completing the study or interfere with the&#xD;
               interpretation of the results; including but not limited to cardiovascular,&#xD;
               gastrointestinal, liver, kidney, neurological, musculoskeletal, infectious, endocrine,&#xD;
               metabolic, hematological diseases, psychiatric or major limb disorders etc.&#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>Dehui Wang, Doctor</last_name>
      <phone>+86 13701852008</phone>
      <email>wangdehuient@sina.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Li Hu, Doctor</last_name>
      <phone>+86 13816837289</phone>
      <email>hl318ent@163.com</email>
    </overall_contact_backup>
    <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>
      <contact>
        <last_name>Shaofeng Liu, Doctor</last_name>
        <phone>+86 15155314908</phone>
        <email>Liusf_cn@163.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>ZhuJiang Hospital of Southern Medical University</name>
        <address>
          <city>Guangzhou</city>
          <state>Guangdong</state>
          <zip>510280</zip>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Hongzheng Zhang, Doctor</last_name>
        <phone>+86 13189097110</phone>
        <email>zhang_hongzheng@yeah.net</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Jieyang People's Hospital</name>
        <address>
          <city>Jieyang</city>
          <state>Guangdong</state>
          <zip>522000</zip>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Chaokai Lin</last_name>
        <phone>+86 18925694433</phone>
        <email>18925694433@163.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>The Fifth Affiliated Hospital Sun Yat-sen University</name>
        <address>
          <city>Zhuhai</city>
          <state>Guangdong</state>
          <zip>519000</zip>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Haiyu Hong, Doctor</last_name>
        <phone>+86 13823070089</phone>
        <email>honghy@sysu.edu.cn</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Affiliated Hospital of Zunyi Medical University</name>
        <address>
          <city>Zunyi</city>
          <state>Guizhou</state>
          <zip>563000</zip>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Zhaohui Liu, Doctor</last_name>
        <phone>+86 13984519373</phone>
        <email>rzent@163.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Cangzhou Central Hospital</name>
        <address>
          <city>Cangzhou</city>
          <state>Hebei</state>
          <zip>061000</zip>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Weiwei Liu, Master</last_name>
        <phone>+86 13393275339</phone>
        <email>lwwczbj@163.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Affiliated Hospital of Inner Mongolia Medical University</name>
        <address>
          <city>Hohhot</city>
          <state>Inner Mongolia</state>
          <zip>010000</zip>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Xiaobo Cui, Doctor</last_name>
        <phone>+86 18686024380</phone>
        <email>cxbgh@sina.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>The Affiliated Hospital of Xuzhou Medical University</name>
        <address>
          <city>Xuzhou</city>
          <state>Jiangsu</state>
          <zip>221000</zip>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Wen Liu, Doctor</last_name>
        <phone>+86 13615102636</phone>
        <email>liuwen1972@163.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Affiliated Zhongshan Hospital Of Dalian University</name>
        <address>
          <city>Dalian</city>
          <state>Liaoning</state>
          <zip>116001</zip>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Tao Jiang, Master</last_name>
        <phone>+86 15142436156</phone>
        <email>15142436156@163.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>The First Affiliated Hospital of Xi'an Jiaotong University</name>
        <address>
          <city>Xi'an</city>
          <state>Shaanxi</state>
          <zip>710100</zip>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Yuan Shao, Doctor</last_name>
        <phone>+86 13609242887</phone>
        <email>yuanshao1976@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>
      <contact>
        <last_name>Yan Jiang, Doctor</last_name>
        <phone>+86 18661808518</phone>
        <email>qdfyent@163.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Weifang Second People's Hospital</name>
        <address>
          <city>Weifang</city>
          <state>Shandong</state>
          <zip>261041</zip>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Guoru Yang, Bachelor</last_name>
        <phone>+86 13963601993</phone>
        <email>yangguoru@163.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Eye &amp; ENT Hospital of Fudan University</name>
        <address>
          <city>Shanghai</city>
          <state>Shanghai</state>
          <zip>200031</zip>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Dehui Wang, Doctor</last_name>
        <phone>+8613701852008</phone>
        <email>wangdehuient@sina.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Chengdu Second People's Hospital</name>
        <address>
          <city>Chengdu</city>
          <state>Sichuan</state>
          <zip>610000</zip>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Gang He, Doctor</last_name>
        <phone>+86 18981838931</phone>
        <email>Scheganghegang@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>
      <contact>
        <last_name>Feng Liu, Doctor</last_name>
        <phone>+86 18628979607</phone>
        <email>396173028@qq.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>The First Affiliated Hospital of Xinjiang Medical University</name>
        <address>
          <city>Ürümqi</city>
          <state>Xinjiang Uygur Autonomous Region</state>
          <zip>830000</zip>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Hua Zhang, Doctor</last_name>
        <phone>+86 13809910111</phone>
        <email>hzhang1106@163.com</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 1, 2023</study_first_submitted>
    <study_first_submitted_qc>September 12, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 14, 2023</study_first_posted>
    <last_update_submitted>September 12, 2023</last_update_submitted>
    <last_update_submitted_qc>September 12, 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>Sinusitis</mesh_term>
      <mesh_term>Nasal Polyps</mesh_term>
      <mesh_term>Polyps</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/NCT06036927
  org study id: TQC2731-II-02
  nct id: NCT06036927
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  This is a multicenter, randomized, double-blind, placebo-controlled Phase II clinical trial
        to evaluate the efficacy, safety and pharmacokinetics of TQC2731 injection in the treatment
        of Chronic Sinusitis with Nasal Polyps.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  measure: Nasal Polyp Score (NPS)
  time frame: Baseline up to 24 weeks
  description: NPS is the sum of the left and right nostril scores evaluated through nasal endoscopy, with a total score range of 0 to 8. NPS is based on polyp grading, with a score of 0-4 based on polyp grading.
  measure: Nasal congestion score (NCS)
  time frame: Baseline up to 24 weeks
  description: NCS is determined by the subjects based on the severity of the nasal congestion in the past 24 hours. This score uses a 0-3 classification scale, where 0=no symptoms, 1=mild symptoms, 2=moderate symptoms, and 3=severe symptoms.
  measure: Anosmia Score
  time frame: Baseline up to 24 weeks
  description: Anosmia Score is evaluated by subjects based on their severity of Anosmia on the day. This score uses a 0-3 classification scale, where 0=no symptoms, 1=mild symptoms, 2=moderate symptoms, and 3=severe symptoms.
  measure: Total symptom score (TSS)
  time frame: Baseline up to 24 weeks
  description: TSS is the sum of nasal congestion, anosmia, and rhinorrhea (the average of anterior and posterior rhinorrhea), with a score range of 0-9 points. The severity is evaluated by the subject and recorded on the subject diary record card.
  measure: Visual analogue scale (VAS) for sinusitis
  time frame: Baseline up to 24 weeks
  description: VAS for sinusitis is a questionnaire that subjective evaluation of the overall severity of sinusitis by subjects, with a score range of 0-10 points. The higher the score, the greater the impact of sinusitis on the quality of life of the subjects.
  measure: Nasal polyp (NP) surgery time
  time frame: Baseline up to 32 weeks
  description: Time to the first nasal polyp (NP) surgery of subjects
  measure: Nasal polyp (NP) surgery ratio
  time frame: Baseline up to 32 weeks
  description: Ratio of subjects who undergo nasal polyp surgery.
  measure: Time of Systemic glucocorticoids (SCS) remedial treatment
  time frame: Baseline up to 32 weeks
  description: Time to first use of systemic glucocorticoids (SCS) as remedial treatment of subjects.
  measure: Ratio of Systemic glucocorticoids (SCS) treatment
  time frame: Baseline up to 32 weeks
  description: Ratio of subjects who using SCS as remedial treatment.
  measure: Lund Mackay (LMK) score
  time frame: Baseline up to 24 weeks
  description: The LMK score is based on the results of sinus Computed Tomography (CT) scans. Evaluated by researchers, divided into left and right sinus systems, with 0-12 points per side and a total score of 0-24 points.
  measure: Incidence of Adverse event (AE)
  time frame: Baseline up to 32 weeks
  description: Incidence of AE, serious adverse event (SAE) and abnormal laboratory tests
  measure: Severity of AE
  time frame: Baseline up to 32 weeks
  description: Severity of AE, serious adverse event (SAE) and abnormal laboratory tests
  measure: Peak concentration (Cmax)
  time frame: Before first administration, 1, 4, 8, 12, 24, 72, 120, 144, 168, 336 hours after first administration; before second, third, fourth and last administration; 1, 4, 8, 12, 24, 72, 168, 336, 672, 1008, 1344, 1992 hours after last administration.
  description: Maximum plasma drug concentration
  measure: Trough concentration (Cmin)
  time frame: Before first administration, 1, 4, 8, 12, 24, 72, 120, 144, 168, 336 hours after first administration; before second, third, fourth and last administration; 1, 4, 8, 12, 24, 72, 168, 336, 672, 1008, 1344, 1992 hours after last administration.
  description: Minimum plasma drug concentration
  measure: Time to Peak concentration (Tmax)
  time frame: Before first administration, 1, 4, 8, 12, 24, 72, 120, 144, 168, 336 hours after first administration; before second, third, fourth and last administration; 1, 4, 8, 12, 24, 72, 168, 336, 672, 1008, 1344, 1992 hours after last administration.
  description: The time when reach maximum plasma drug concentration
  measure: Area under the concentration time curve (AUC0-t)
  time frame: Before first administration, 1, 4, 8, 12, 24, 72, 120, 144, 168, 336 hours after first administration; before second, third, fourth and last administration; 1, 4, 8, 12, 24, 72, 168, 336, 672, 1008, 1344, 1992 hours after last administration.
  description: The area enclosed by the plasma concentration curve to the timeline
  measure: Maximum plasma concentration at steady state (Css-max)
  time frame: Before first administration, 1, 4, 8, 12, 24, 72, 120, 144, 168, 336 hours after first administration; before second, third, fourth and last administration; 1, 4, 8, 12, 24, 72, 168, 336, 672, 1008, 1344, 1992 hours after last administration.
  description: The maximum plasma concentration after stabilization
  measure: Minimum plasma concentration at steady state (Css-min)
  time frame: Before first administration, 1, 4, 8, 12, 24, 72, 120, 144, 168, 336 hours after first administration; before second, third, fourth and last administration; 1, 4, 8, 12, 24, 72, 168, 336, 672, 1008, 1344, 1992 hours after last administration.
  description: The minimum plasma concentration after stabilization
  measure: Plasma concentration at steady state (Css-av)
  time frame: Before first administration, 1, 4, 8, 12, 24, 72, 120, 144, 168, 336 hours after first administration; before second, third, fourth and last administration; 1, 4, 8, 12, 24, 72, 168, 336, 672, 1008, 1344, 1992 hours after last administration.
  description: The plasma concentration at which the rate of administration and rate of elimination are in equilibrium.
  measure: Time to Peak concentration at steady state (Tss-max)
  time frame: Before first administration, 1, 4, 8, 12, 24, 72, 120, 144, 168, 336 hours after first administration; before second, third, fourth and last administration; 1, 4, 8, 12, 24, 72, 168, 336, 672, 1008, 1344, 1992 hours after last administration.
  description: The time when maximum plasma drug concentration at steady state.
  measure: Area under the concentration time curve (AUC0-t) at steady state
  time frame: Before first administration, 1, 4, 8, 12, 24, 72, 120, 144, 168, 336 hours after first administration; before second, third, fourth and last administration; 1, 4, 8, 12, 24, 72, 168, 336, 672, 1008, 1344, 1992 hours after last administration.
  description: The area enclosed by the plasma concentration curve to the timeline at steady state.
  measure: Half life (t1/2)
  time frame: Before first administration, 1, 4, 8, 12, 24, 72, 120, 144, 168, 336 hours after first administration; before second, third, fourth and last administration; 1, 4, 8, 12, 24, 72, 168, 336, 672, 1008, 1344, 1992 hours after last administration.
  description: The time taken for the plasma concentration to be reduced by half.
  measure: Apparent volume distribution (Vd/F)
  time frame: Before first administration, 1, 4, 8, 12, 24, 72, 120, 144, 168, 336 hours after first administration; before second, third, fourth and last administration; 1, 4, 8, 12, 24, 72, 168, 336, 672, 1008, 1344, 1992 hours after last administration.
  description: It refers to the ratio between the body drug amount and the blood drug concentration after the drug has reached dynamic equilibrium in the body.
  measure: Plasma clearance (CL/F)
  time frame: Before first administration, 1, 4, 8, 12, 24, 72, 120, 144, 168, 336 hours after first administration; before second, third, fourth and last administration; 1, 4, 8, 12, 24, 72, 168, 336, 672, 1008, 1344, 1992 hours after last administration.
  description: The volume of plasma cleared of drug per unit time.
  measure: Anti-drug antibody (ADA)
  time frame: Within 1 hour before administration on Day 1, Day 169, Day 224, during withdrawal
  description: Incidence and their titers of Anti-drug antibody (ADA)
  measure: Neutralizing antibody (Nab)
  time frame: Within 1 hour before administration on Day 1, Day 169, Day 224, during withdrawal
  description: Incidence and their titers of Neutralizing antibody (Nab)
  arm group label: TQC2731 injection 210 mg
  arm group type: Experimental
  description: TQC2731 injection 210 mg combined with Mometasone Furoate Aqueous Nasal Spray, 28 days as a treatment cycle.
  arm group label: TQC2731 injection 420 mg
  arm group type: Experimental
  description: TQC2731 injection 420 mg combined with Mometasone Furoate Aqueous Nasal Spray, 28 days as a treatment cycle.
  arm group label: TQC2731 matching placebo
  arm group type: Placebo Comparator
  description: TQC2731 matching placebo combined with Mometasone Furoate Aqueous Nasal Spray, 28 days as a treatment cycle.
  intervention type: Drug
  intervention name: TQC2731 injection
  description: TQC2731 injection is a thymic stromal lymphopoietin (TSLP) monoclonal antibody.
  arm group label: TQC2731 injection 210 mg
  arm group label: TQC2731 injection 420 mg
  intervention type: Drug
  intervention name: TQC2731 matching placebo
  description: It'a a placebo injection without active substances.
  arm group label: TQC2731 matching placebo
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: No
  last name: Dehui Wang, Doctor
  phone: +86 13701852008
  email: wangdehuient@sina.com
  last name: Li Hu, Doctor
  phone: +86 13816837289
  email: hl318ent@163.com
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  country: China
  responsible party type: Sponsor
  mesh term: Sinusitis
  mesh term: Nasal Polyps
  mesh term: Polyps