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CompletedNCT06036927Updated Apr 16, 2025

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

A Phase 2 interventional study of TQC2731 injection and TQC2731 matching placebo in Chronic Sinusitis and Nasal Polyps, sponsored by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.. Completed at 16 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-04-16.

Sponsored by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Chronic Sinusitis
  • Nasal Polyps
03

In context

Sinusitis

415 studies on the registry are indexed under Sinusitis; 46 are open to participants now.

This study's enrollment of 80 is above the median of 60 across 313 interventional studies indexed under Sinusitis.

Browse Sinusitis studies →

Lead sponsor

Chia Tai Tianqing Pharmaceutical Group Co., Ltd. is the lead sponsor of 313 studies on the registry; 75 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
80 participants (actual)

Study arms

  • 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

  • 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

  • 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

Interventions

  • DrugTQC2731 injection

    TQC2731 injection is a thymic stromal lymphopoietin (TSLP) monoclonal antibody.

  • DrugTQC2731 matching placebo

    It'a a placebo injection without active substances.

06

What researchers measure

Primary outcomes

  1. Nasal Polyp Score (NPS)

    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.

    Time frame: Baseline up to 24 weeks

Secondary outcomes

  1. Nasal congestion score (NCS)

    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.

    Time frame: Baseline up to 24 weeks

  2. Anosmia Score

    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.

    Time frame: Baseline up to 24 weeks

  3. Total symptom score (TSS)

    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.

    Time frame: Baseline up to 24 weeks

  4. Visual analogue scale (VAS) for sinusitis

    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.

    Time frame: Baseline up to 24 weeks

  5. Nasal polyp (NP) surgery time

    Time to the first nasal polyp (NP) surgery of subjects

    Time frame: Baseline up to 32 weeks

  6. Nasal polyp (NP) surgery ratio

    Ratio of subjects who undergo nasal polyp surgery.

    Time frame: Baseline up to 32 weeks

  7. Time of Systemic glucocorticoids (SCS) remedial treatment

    Time to first use of systemic glucocorticoids (SCS) as remedial treatment of subjects.

    Time frame: Baseline up to 32 weeks

  8. Ratio of Systemic glucocorticoids (SCS) treatment

    Ratio of subjects who using SCS as remedial treatment.

    Time frame: Baseline up to 32 weeks

  9. Lund Mackay (LMK) score

    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.

    Time frame: Baseline up to 24 weeks

  10. Incidence of Adverse event (AE)

    Incidence of AE, serious adverse event (SAE) and abnormal laboratory tests

    Time frame: Baseline up to 32 weeks

  11. Severity of AE

    Severity of AE, serious adverse event (SAE) and abnormal laboratory tests

    Time frame: Baseline up to 32 weeks

  12. Peak concentration (Cmax)

    Maximum plasma drug concentration

    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.

  13. Trough concentration (Cmin)

    Minimum plasma drug concentration

    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.

  14. Time to Peak concentration (Tmax)

    The time when reach maximum plasma drug concentration

    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.

  15. Area under the concentration time curve (AUC0-t)

    The area enclosed by the plasma concentration curve to the timeline

    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.

  16. Maximum plasma concentration at steady state (Css-max)

    The maximum plasma concentration after stabilization

    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.

  17. Minimum plasma concentration at steady state (Css-min)

    The minimum plasma concentration after stabilization

    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.

  18. Plasma concentration at steady state (Css-av)

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

    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.

  19. Time to Peak concentration at steady state (Tss-max)

    The time when maximum plasma drug concentration 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.

  20. Area under the concentration time curve (AUC0-t) at steady state

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

  21. Half life (t1/2)

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

    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.

  22. Apparent volume distribution (Vd/F)

    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.

    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.

  23. Plasma clearance (CL/F)

    The volume of plasma cleared of drug per unit time.

    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.

  24. Anti-drug antibody (ADA)

    Incidence and their titers of Anti-drug antibody (ADA)

    Time frame: Within 1 hour before administration on Day 1, Day 169, Day 224, during withdrawal

  25. Neutralizing antibody (Nab)

    Incidence and their titers of Neutralizing antibody (Nab)

    Time frame: Within 1 hour before administration on Day 1, Day 169, Day 224, during withdrawal

07

Study locations

16 sites
  • The First Affiliated Hospital of Wannan Medical College
    Wuhu, Anhui 241000, China
  • ZhuJiang Hospital of Southern Medical University
    Guangzhou, Guangdong 510280, China
  • Jieyang People's Hospital
    Jieyang, Guangdong 522000, China
  • The Fifth Affiliated Hospital Sun Yat-sen University
    Zhuhai, Guangdong 519000, China
  • Affiliated Hospital of Zunyi Medical University
    Zunyi, Guizhou 563000, China
  • Cangzhou Central Hospital
    Cangzhou, Hebei 061000, China
  • Affiliated Hospital of Inner Mongolia Medical University
    Hohhot, Inner Mongolia 010000, China
  • The Affiliated Hospital of Xuzhou Medical University
    Xuzhou, Jiangsu 221000, China
  • Affiliated Zhongshan Hospital Of Dalian University
    Dalian, Liaoning 116001, China
  • The First Affiliated Hospital of Xi'an Jiaotong University
    Xi'an, Shaanxi 710100, China
  • The Affiliated Hospital of Qingdao University
    Qingdao, Shandong 266000, China
  • Weifang Second People's Hospital
    Weifang, Shandong 261041, China
  • Eye & ENT Hospital of Fudan University
    Shanghai, Shanghai 200031, China
  • Chengdu Second People's Hospital
    Chengdu, Sichuan 610000, China
  • West China Hospital of Sichuan University
    Chengdu, Sichuan 610041, China
  • The First Affiliated Hospital of Xinjiang Medical University
    Ürümqi, Xinjiang Uygur Autonomous Region 830000, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 16, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06036927
Lead sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Responsible party
Sponsor
First posted
Sep 14, 2023
Start date
Dec 8, 2023
Primary completion
Feb 5, 2025
Completion
Mar 27, 2025
Last update
Apr 16, 2025

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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