Chronic SinusitisPhase 2NCT06036927
A Clinical Study of TQC2731 Injection in the Treatment of Chronic Rhinosinusitis With Nasal Polyps
A Phase 2 study testing TQC2731 injection in people with Chronic Sinusitis and Nasal Polyps, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 16 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Sinusitis, Nasal Polyps
- What is being tested?
- TQC2731 injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 16 sitesChina
- Study dates
- 8 Dec 2023to 27 Mar 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- Presence of conditions/concomitant diseases that affect the evaluation of efficacy, such as:
- Posterior nostril polyps;
- Deviation of the nasal septum resulted in obstruction of at least one nostril;
- Acute sinusitis, nasal infection, or upper respiratory tract infection had occurred 2 weeks before screening, screening period or mediation period;
- Drug induced rhinitis;
- 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;
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- Imaging suspected or confirmed fungal sinusitis;
- NPS cannot be evaluated due to nasal surgery to alter the structure of the lateral nasal wall;
- 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:
- 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.);
- 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.);
- Received systemic glucocorticoids within 28 days before the study;
- Glucocorticoid-eluting nasal stents were used within 6 months before the study;
- Immune globulin or blood products therapy were used within 28 days before the study;
- Received or planned to receive live attenuated vaccine within 28 days before or during the study period;
- 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);
- 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:
- White cell count<3.5 x 10^9/L;
- Aspartate aminotransferase (AST) > 2.5 x upper limits of normal (ULN);
- Alanine aminotransferase (ALT) > 2.5 x ULN;
- Total bilirubin > 2 x ULN;
- Creatine phosphokinase (CPK)> 2 x ULN;
- 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.
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
China16 sites
Cangzhou Central Hospital
Cangzhou, Hebei, 061000
Chengdu Second People's Hospital
Chengdu, Sichuan, 610000
West China Hospital of Sichuan University
Chengdu, Sichuan, 610041
Affiliated Zhongshan Hospital Of Dalian University
Dalian, Liaoning, 116001
ZhuJiang Hospital of Southern Medical University
Guangzhou, Guangdong, 510280
Affiliated Hospital of Inner Mongolia Medical University
Hohhot, Inner Mongolia, 010000
Jieyang People's Hospital
Jieyang, Guangdong, 522000
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, 266000
Eye & ENT Hospital of Fudan University
Shanghai, Shanghai Municipality, 200031
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang Uygur Autonomous Region, 830000
Weifang Second People's Hospital
Weifang, Shandong, 261041
The First Affiliated Hospital of Wannan Medical College
Wuhu, Anhui, 241000
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710100
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, 221000
The Fifth Affiliated Hospital Sun Yat-sen University
Zhuhai, Guangdong, 519000
Affiliated Hospital of Zunyi Medical University
Zunyi, Guizhou, 563000
About this study
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.
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.
- Conditions
- Chronic Sinusitis, Nasal Polyps
- Being tested
- TQC2731 injection, TQC2731 matching placebo
- Medical subject headings
- Nasal Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TQC2731 injectionDrug
TQC2731 injection is a thymic stromal lymphopoietin (TSLP) monoclonal antibody.
TQC2731 matching placeboDrug
It'a a placebo injection without active substances.
| Study group | Role | What they receive |
|---|---|---|
| TQC2731 injection 210 mg | Experimental | TQC2731 injection 210 mg combined with Mometasone Furoate Aqueous Nasal Spray, 28 days as a treatment cycle. Receives: Drug: TQC2731 injection |
| TQC2731 injection 420 mg | Experimental | TQC2731 injection 420 mg combined with Mometasone Furoate Aqueous Nasal Spray, 28 days as a treatment cycle. Receives: Drug: TQC2731 injection |
| TQC2731 matching placebo | Placebo comparator | TQC2731 matching placebo combined with Mometasone Furoate Aqueous Nasal Spray, 28 days as a treatment cycle. Receives: Drug: TQC2731 matching placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline up to 24 weeks
Secondary outcomes (25)
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.
Measured: Baseline up to 24 weeks
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.
Measured: Baseline up to 24 weeks
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.
Measured: Baseline up to 24 weeks
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.
Measured: Baseline up to 24 weeks
Nasal polyp (NP) surgery time
Time to the first nasal polyp (NP) surgery of subjects
Measured: Baseline up to 32 weeks
Nasal polyp (NP) surgery ratio
Ratio of subjects who undergo nasal polyp surgery.
Measured: Baseline up to 32 weeks
Time of Systemic glucocorticoids (SCS) remedial treatment
Time to first use of systemic glucocorticoids (SCS) as remedial treatment of subjects.
Measured: Baseline up to 32 weeks
Ratio of Systemic glucocorticoids (SCS) treatment
Ratio of subjects who using SCS as remedial treatment.
Measured: Baseline up to 32 weeks
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.
Measured: Baseline up to 24 weeks
Incidence of Adverse event (AE)
Incidence of AE, serious adverse event (SAE) and abnormal laboratory tests
Measured: Baseline up to 32 weeks
Severity of AE
Severity of AE, serious adverse event (SAE) and abnormal laboratory tests
Measured: Baseline up to 32 weeks
Peak concentration (Cmax)
Maximum plasma drug concentration
Measured: 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.
Trough concentration (Cmin)
Minimum plasma drug concentration
Measured: 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 to Peak concentration (Tmax)
The time when reach maximum plasma drug concentration
Measured: 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.
Area under the concentration time curve (AUC0-t)
The area enclosed by the plasma concentration curve to the timeline
Measured: 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 concentration at steady state (Css-max)
The maximum plasma concentration after stabilization
Measured: 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 concentration at steady state (Css-min)
The minimum plasma concentration after stabilization
Measured: 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.
Plasma concentration at steady state (Css-av)
The plasma concentration at which the rate of administration and rate of elimination are in equilibrium.
Measured: 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 to Peak concentration at steady state (Tss-max)
The time when maximum plasma drug concentration at steady state.
Measured: 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.
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.
Measured: 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.
Half life (t1/2)
The time taken for the plasma concentration to be reduced by half.
Measured: 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.
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.
Measured: 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.
Plasma clearance (CL/F)
The volume of plasma cleared of drug per unit time.
Measured: 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.
Anti-drug antibody (ADA)
Incidence and their titers of Anti-drug antibody (ADA)
Measured: Within 1 hour before administration on Day 1, Day 169, Day 224, during withdrawal
Neutralizing antibody (Nab)
Incidence and their titers of Neutralizing antibody (Nab)
Measured: Within 1 hour before administration on Day 1, Day 169, Day 224, during withdrawal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2023
- Study start8 Dec 2023
- Primary completion5 Feb 2025
- Study completion27 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic SinusitisStudies of the same condition, open and under way.
- More trials run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06036927
- Sponsor's protocol ID
- TQC2731-II-02
- Status last verified
- Mar 2025
- First submitted
- 1 Sep 2023
- Last updated
- 16 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06036927
- Acronym / sponsor ID
- TQC2731-II-02
- Conditions
- Chronic Sinusitis, Nasal Polyps
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 8 Dec 2023 (actual)
- Primary completion
- 5 Feb 2025 (actual)
- Study completion
- 27 Mar 2025 (actual)
- First posted
- 14 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TQC2731 injection 210 mg | Experimental | Drug: TQC2731 injectionTQC2731 injection 210 mg combined with Mometasone Furoate Aqueous Nasal Spray, 28 days as a treatment cycle. |
| TQC2731 injection 420 mg | Experimental | Drug: TQC2731 injectionTQC2731 injection 420 mg combined with Mometasone Furoate Aqueous Nasal Spray, 28 days as a treatment cycle. |
| TQC2731 matching placebo | Placebo comparator | Drug: TQC2731 matching placeboTQC2731 matching placebo combined with Mometasone Furoate Aqueous Nasal Spray, 28 days as a treatment cycle. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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;
Key exclusion criteria (43 listed)
- Presence of conditions/concomitant diseases that affect the evaluation of efficacy, such as:
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TQC2731 injectionTQC2731 injection is a thymic stromal lymphopoietin (TSLP) monoclonal antibody. | Drug | TQC2731 injection 210 mg, TQC2731 injection 420 mg |
| TQC2731 matching placeboIt'a a placebo injection without active substances. | Drug | TQC2731 matching placebo |
Primary outcome
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.
25 secondary outcomes
Nasal congestion score (NCS)
Time frame: Baseline up to 24 weeks
Anosmia Score
Time frame: Baseline up to 24 weeks
Total symptom score (TSS)
Time frame: Baseline up to 24 weeks
Visual analogue scale (VAS) for sinusitis
Time frame: Baseline up to 24 weeks
Nasal polyp (NP) surgery time
Time frame: Baseline up to 32 weeks
Nasal polyp (NP) surgery ratio
Time frame: Baseline up to 32 weeks
Time of Systemic glucocorticoids (SCS) remedial treatment
Time frame: Baseline up to 32 weeks
Ratio of Systemic glucocorticoids (SCS) treatment
Time frame: Baseline up to 32 weeks
Lund Mackay (LMK) score
Time frame: Baseline up to 24 weeks
Incidence of Adverse event (AE)
Time frame: Baseline up to 32 weeks
Severity of AE
Time frame: Baseline up to 32 weeks
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Anti-drug antibody (ADA)
Time frame: Within 1 hour before administration on Day 1, Day 169, Day 224, during withdrawal
Neutralizing antibody (Nab)
Time frame: Within 1 hour before administration on Day 1, Day 169, Day 224, during withdrawal
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2025.
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Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
Not yet recruiting
FESS With or Without Intranasal Desmopressin in Chronic Rhinosinusitis With Nasal Polyps
Chronic Sinusitis, Nasal Polyposis
Not yet recruiting
Effect of Probiotic Nasal Irrigation on the Postoperative Care of Chronic Rhinosinusitis
Sinusitis Chronic, Postoperative Care
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TQC2731 injection in people with Chronic Sinusitis and Nasal Polyps, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 16 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 43 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nasal Polyp Score (NPS) (time frame: Baseline up to 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2025.