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A Clinical Study of TQC2731 Injection in the Treatment of Chronic Rhinosinusitis With Nasal Polyps

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ClinicalTrials.gov Identifier: NCT06036927
Recruitment Status : Recruiting
First Posted : September 14, 2023
Last Update Posted : January 5, 2024
Sponsor:
Information provided by (Responsible Party):
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Chronic Sinusitis Nasal Polyps Drug: TQC2731 injection Drug: TQC2731 matching placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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.
Actual Study Start Date : December 8, 2023
Estimated Primary Completion Date : July 2025
Estimated Study Completion Date : September 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sinusitis

Arms and Interventions
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Arm Intervention/treatment
Experimental: TQC2731 injection 210 mg
TQC2731 injection 210 mg combined with Mometasone Furoate Aqueous Nasal Spray, 28 days as a treatment cycle.
 Drug: TQC2731 injection
TQC2731 injection is a thymic stromal lymphopoietin (TSLP) monoclonal antibody.
Experimental: TQC2731 injection 420 mg
TQC2731 injection 420 mg combined with Mometasone Furoate Aqueous Nasal Spray, 28 days as a treatment cycle.
 Drug: TQC2731 injection
TQC2731 injection is a thymic stromal lymphopoietin (TSLP) monoclonal antibody.
Placebo Comparator: TQC2731 matching placebo
TQC2731 matching placebo combined with Mometasone Furoate Aqueous Nasal Spray, 28 days as a treatment cycle.
 Drug: TQC2731 matching placebo
It'a a placebo injection without active substances.


Outcome Measures
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Primary Outcome Measures :
  1. Nasal Polyp Score (NPS) [ Time Frame: Baseline up to 24 weeks ]
    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.


Secondary Outcome Measures :
  1. Nasal congestion score (NCS) [ Time Frame: Baseline up to 24 weeks ]
    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.

  2. Anosmia Score [ Time Frame: Baseline up to 24 weeks ]
    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.

  3. Total symptom score (TSS) [ Time Frame: Baseline up to 24 weeks ]
    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.

  4. Visual analogue scale (VAS) for sinusitis [ Time Frame: Baseline up to 24 weeks ]
    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.

  5. Nasal polyp (NP) surgery time [ Time Frame: Baseline up to 32 weeks ]
    Time to the first nasal polyp (NP) surgery of subjects

  6. Nasal polyp (NP) surgery ratio [ Time Frame: Baseline up to 32 weeks ]
    Ratio of subjects who undergo nasal polyp surgery.

  7. Time of Systemic glucocorticoids (SCS) remedial treatment [ Time Frame: Baseline up to 32 weeks ]
    Time to first use of systemic glucocorticoids (SCS) as remedial treatment of subjects.

  8. Ratio of Systemic glucocorticoids (SCS) treatment [ Time Frame: Baseline up to 32 weeks ]
    Ratio of subjects who using SCS as remedial treatment.

  9. Lund Mackay (LMK) score [ Time Frame: Baseline up to 24 weeks ]
    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.

  10. Incidence of Adverse event (AE) [ Time Frame: Baseline up to 32 weeks ]
    Incidence of AE, serious adverse event (SAE) and abnormal laboratory tests

  11. Severity of AE [ Time Frame: Baseline up to 32 weeks ]
    Severity of AE, serious adverse event (SAE) and abnormal laboratory tests

  12. 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. ]
    Maximum plasma drug concentration

  13. 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. ]
    Minimum plasma drug concentration

  14. 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. ]
    The time when reach maximum plasma drug concentration

  15. 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. ]
    The area enclosed by the plasma concentration curve to the timeline

  16. 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. ]
    The maximum plasma concentration after stabilization

  17. 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. ]
    The minimum plasma concentration after stabilization

  18. 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. ]
    The plasma concentration at which the rate of administration and rate of elimination are in equilibrium.

  19. 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. ]
    The time when maximum plasma drug concentration at steady state.

  20. 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. ]
    The area enclosed by the plasma concentration curve to the timeline at steady state.

  21. 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. ]
    The time taken for the plasma concentration to be reduced by half.

  22. 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. ]
    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.

  23. 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. ]
    The volume of plasma cleared of drug per unit time.

  24. Anti-drug antibody (ADA) [ Time Frame: Within 1 hour before administration on Day 1, Day 169, Day 224, during withdrawal ]
    Incidence and their titers of Anti-drug antibody (ADA)

  25. Neutralizing antibody (Nab) [ Time Frame: Within 1 hour before administration on Day 1, Day 169, Day 224, during withdrawal ]
    Incidence and their titers of Neutralizing antibody (Nab)


Eligibility Criteria
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Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects sign informed consent before study, fully understand the purpose, procedures and possible adverse reactions of the study;
  • Male and female, ≥18 years old and ≤ 75 years old;
  • Bilateral chronic rhinosinusitis with nasal polyps (CRSwNP) who met the diagnostic criteria of the Chinese Guidelines for the Diagnosis and Treatment of chronic rhinosinusitis (2018);
  • Received nasal polyp surgery or received systemic glucocorticoid treatment 2 years before screening;
  • Bilateral nasal polyp score (NPS) ≥5 and each nostril was scored ≥ 2 when screening and randomization;
  • Nasal congestion score (NCS) ≥2 when screening and randomization;
  • Persistent nasal leakage or smell decrease or loss last more than 8 weeks before screening;
  • Sinonasal outcome testing 22 (SNOT-22) score ≥ 30 when screening and randomization;
  • Subjects received steady dose of intranasal glucocorticoids (INCS) over 4 weeks before screening (subjects agree use Mometasone Furoate Aqueous Nasal Spray (MFNS) while studying);
  • Subjects with asthma start inhaled stable dose of glucocorticoid therapy over 4 weeks before screening, and are willing to keep the dose during whole study;
  • MFNS medication compliance ≥70%, subjects daily symptom assessment compliance ≥70% through Patient dairy;
  • Subjects agree to take effective non-pharmaceutical contraception from signing informed consent to 6 mouth after last administration.

Exclusion Criteria:

  • Presence of conditions/concomitant diseases that affect the evaluation of efficacy, such as:

    1. Posterior nostril polyps;
    2. Deviation of the nasal septum resulted in obstruction of at least one nostril;
    3. Acute sinusitis, nasal infection, or upper respiratory tract infection had occurred 2 weeks before screening, screening period or mediation period;
    4. Drug induced rhinitis;
    5. Allergic granulomatous vasculitis (Churg-Strauss syndrome), granuloma with poly vasculitis (Wegener's granuloma), Young syndrome, Kartagener syndrome, or other dysphoric ciliary syndrome, with cystic fibrosis;
    6. Imaging suspected or confirmed fungal sinusitis;
    7. NPS cannot be evaluated due to nasal surgery to alter the structure of the lateral nasal wall;
    8. Subjects with nasal malignancies and benign tumors (papilloma, blood furuncle, etc.)
  • Any type of active malignancy or a history of malignancy (Patient with basal cell carcinoma, skin localized squamous cell carcinoma or carcinoma in situ of cervix, can participate in the study if curative treatment was completed for more than 12 months prior to visit 1; Patients with other malignant tumors can participate in the study if curative therapy had been completed for at least 5 years prior to visit 1);
  • Active autoimmune disease (including but not limited to Hashimoto's thyroiditis, Graves disease, Inflammatory bowel disease, Primary biliary cholangitis, Systemic lupus erythematosus, Multiple sclerosis and other neuroinflammatory diseases, Psoriasis vulgaris, Rheumatoid arthritis);
  • Known or suspected history of immunosuppression, immune disorders, or immune disorders, including but not limited to invasive opportunistic infections (histoplasmosis, listeriosis, coccidioides, pulmonary cysticercosis disease, aspergillosis), even if the infection has been resolved;
  • Any intranasal and/or sinus surgery (including polypectomy) within 6 months before screening;
  • Uncontrolled epistaxis occurred within 2 months before screening;
  • A history of active pulmonary tuberculosis in the 12 months before screening;
  • Infection requiring treatment with systemic antibacterial, antiviral, antifungal, antiparasitic, or antiparasitic agents occurred within 14 days before screening;
  • Helminth parasite infection was diagnosed within 24 weeks prior to screening and had not received or failed to respond to standard treatment;
  • Leukotriene antagonists/modulators were used while screening (using a stable dose of leukotriene modulator for ≥30 days before screening was acceptable);
  • Regular use of decongestants (topical or systemic) before screening, except for short-term use for endoscopy;

  • Patients who received any of the following treatments before screening:

    1. Received immunosuppressive therapy within the previous 8 weeks or five half-lives (whichever was longer), (including but not limited to cyclophosphamide, cyclosporine, interferon-γ, azathioprine, methotrexate, mycophenolate mofetil and tacrolimus, etc.);
    2. Received monoclonal antibody therapy within the previous 8 weeks or five half-lives (whichever was longer), (Including but not limited to: benralizumab, mepolizumab, omalizumab, resveratrol, dupilumab, etc.);
    3. Received systemic glucocorticoids within 28 days before the study;
    4. Glucocorticoid-eluting nasal stents were used within 6 months before the study;
    5. Immune globulin or blood products therapy were used within 28 days before the study;
    6. Received or planned to receive live attenuated vaccine within 28 days before or during the study period;
    7. Received allergen specific immunotherapy 6 mouth before screening (if started at 3 mouth before screening, being treated at a stable dose in 1 mouth before visit 1 and not expected to change during study, it would be acceptable);
    8. Join any other clinical trials within 3 months;
  • Patients with concurrent asthma had any of the following conditions: forced expiratory volume in the first second (FEV1) ≤ 50% of the expected normal value, or acute exacerbation of asthma within 90 days prior to screening, requiring hospitalization (>24 hours), or taking a daily dose greater than 1000 μg of fluticasone or equivalent inhaled glucocorticoids (ICS);
  • Hepatitis B surface Antigen (HBsAg) positive, or Hepatitis B core antibody (HBcAb) positive and Hepatitis B virus deoxyribonucleic acid (HBV-DNA) positive, or anti-hepatitis C virus (Anti-HCV) positive and Hepatitis C virus ribonucleic acid (HCV-RNA) positive, or anti-human Immunodeficiency Virus (Anti-HIV) positive, or anti-treponema pallidum (Anti-TP) positive;
  • Any clinically significant abnormal findings, include physical examination, vital signs, 12-lead electrocardiogram, blood biochemistry, blood routine or urine routine, and investigator judged that participating in the trial may put the patient at risk, or may affect the study outcome or hinder the patient's ability to complete the entire study process;

  • Lab tests results were abnormal:

    1. White cell count<3.5 x 10^9/L;
    2. Aspartate aminotransferase (AST) > 2.5 x upper limits of normal (ULN);
    3. Alanine aminotransferase (ALT) > 2.5 x ULN;
    4. Total bilirubin > 2 x ULN;
    5. Creatine phosphokinase (CPK)> 2 x ULN;
    6. Creatinine >1.5 x ULN
  • Pregnant or lactating women;
  • A allergic history or allergic reaction to Mometasone furoate nasal spray (Nasonex®) or any component of TQC2731 injection;
  • A history of systemic allergy to any biologic drug (except local injection site reactions);
  • The subjects had poor compliance and were judged unable to complete the study;
  • Any medical or psychiatric disorder that was considered by the investigator or the sponsor medical reviewer to be likely to affect the safety of the subjects throughout the study or to prevent the subjects from completing the study or interfere with the interpretation of the results; including but not limited to cardiovascular, gastrointestinal, liver, kidney, neurological, musculoskeletal, infectious, endocrine, metabolic, hematological diseases, psychiatric or major limb disorders etc.
Contacts and Locations
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06036927


Contacts
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Contact: Dehui Wang, Doctor +86 13701852008 wangdehuient@sina.com
Contact: Li Hu, Doctor +86 13816837289 hl318ent@163.com

Locations
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China, Anhui
The First Affiliated Hospital of Wannan Medical College Not yet recruiting
Wuhu, Anhui, China, 241000
Contact: Shaofeng Liu, Doctor    +86 15155314908    Liusf_cn@163.com   
China, Guangdong
ZhuJiang Hospital of Southern Medical University Not yet recruiting
Guangzhou, Guangdong, China, 510280
Contact: Hongzheng Zhang, Doctor    +86 13189097110    zhang_hongzheng@yeah.net   
Jieyang People's Hospital Not yet recruiting
Jieyang, Guangdong, China, 522000
Contact: Chaokai Lin    +86 18925694433    18925694433@163.com   
The Fifth Affiliated Hospital Sun Yat-sen University Not yet recruiting
Zhuhai, Guangdong, China, 519000
Contact: Haiyu Hong, Doctor    +86 13823070089    honghy@sysu.edu.cn   
China, Guizhou
Affiliated Hospital of Zunyi Medical University Not yet recruiting
Zunyi, Guizhou, China, 563000
Contact: Zhaohui Liu, Doctor    +86 13984519373    rzent@163.com   
China, Hebei
Cangzhou Central Hospital Not yet recruiting
Cangzhou, Hebei, China, 061000
Contact: Weiwei Liu, Master    +86 13393275339    lwwczbj@163.com   
China, Inner Mongolia
Affiliated Hospital of Inner Mongolia Medical University Recruiting
Hohhot, Inner Mongolia, China, 010000
Contact: Xiaobo Cui, Doctor    +86 18686024380    cxbgh@sina.com   
China, Jiangsu
The Affiliated Hospital of Xuzhou Medical University Not yet recruiting
Xuzhou, Jiangsu, China, 221000
Contact: Wen Liu, Doctor    +86 13615102636    liuwen1972@163.com   
China, Liaoning
Affiliated Zhongshan Hospital Of Dalian University Not yet recruiting
Dalian, Liaoning, China, 116001
Contact: Tao Jiang, Master    +86 15142436156    15142436156@163.com   
China, Shaanxi
The First Affiliated Hospital of Xi'an Jiaotong University Not yet recruiting
Xi'an, Shaanxi, China, 710100
Contact: Yuan Shao, Doctor    +86 13609242887    yuanshao1976@163.com   
China, Shandong
The Affiliated Hospital of Qingdao University Not yet recruiting
Qingdao, Shandong, China, 266000
Contact: Yan Jiang, Doctor    +86 18661808518    qdfyent@163.com   
Weifang Second People's Hospital Not yet recruiting
Weifang, Shandong, China, 261041
Contact: Guoru Yang, Bachelor    +86 13963601993    yangguoru@163.com   
China, Shanghai
Eye & ENT Hospital of Fudan University Recruiting
Shanghai, Shanghai, China, 200031
Contact: Dehui Wang, Doctor    +8613701852008    wangdehuient@sina.com   
China, Sichuan
Chengdu Second People's Hospital Not yet recruiting
Chengdu, Sichuan, China, 610000
Contact: Gang He, Doctor    +86 18981838931    Scheganghegang@163.com   
West China Hospital of Sichuan University Not yet recruiting
Chengdu, Sichuan, China, 610041
Contact: Feng Liu, Doctor    +86 18628979607    396173028@qq.com   
China, Xinjiang Uygur Autonomous Region
The First Affiliated Hospital of Xinjiang Medical University Not yet recruiting
Ürümqi, Xinjiang Uygur Autonomous Region, China, 830000
Contact: Hua Zhang, Doctor    +86 13809910111    hzhang1106@163.com   
Sponsors and Collaborators
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
More Information
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Responsible Party: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
ClinicalTrials.gov Identifier: NCT06036927    
Other Study ID Numbers: TQC2731-II-02
First Posted: September 14, 2023    Key Record Dates
Last Update Posted: January 5, 2024
Last Verified: December 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Sinusitis
Nasal Polyps
Polyps
Pathological Conditions, Anatomical
Respiratory Tract Infections
 Infections
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases