Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)Phase 3NCT07107256
Clinical Trial of TQC2731 Injection in Patients With Chronic Sinusitis and Nasal Polyps
A Phase 3 study testing TQC2731 injection in people with Chronic Rhinosinusitis With Nasal Polyps (CRSwNP), run by Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd. at 60 sites in China.
Trial summary
TQC2731 injection is a humanized monoclonal antibody that targets Thymic Stromal Lymphopoietin (TSLP), blocks the TSLP pathway, and inhibits the production of downstream cytokines, thereby exerting anti-inflammatory effects. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
- 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
- 246 participants
- Where
- 60 sitesChina
- Study dates
- 25 Sep 2025to Sep 2027
- Phase
- Phase 3
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
- Signed informed consent form prior to trial participation, demonstrating full understanding of trial objectives, procedures, and potential adverse reactions.
- Age between 18 and 75 years (inclusive) at the time of informed consent signing, regardless of gender.
- Diagnosis of bilateral chronic rhinosinusitis with nasal polyps (CRSwNP) meeting the diagnostic criteria of the "Chinese Guidelines for the Diagnosis and Treatment of Chronic Rhinosinusitis (2018)"
- At least one prior course of systemic corticosteroids (prednisone 0.5-1 mg/kg/day or 15-30 mg/day or equivalent for minimum 5 days) within 2 years before screening, with persistent bilateral CRSwNP; AND/OR contraindication/intolerance to systemic corticosteroids; AND/OR prior nasal polyp surgery performed more than 6 months before screening.
- Bilateral Nasal Polyp Score (NPS) ≥5 (maximum score 8) with ≥2 points per nostril, as assessed by nasal endoscopy during screening and randomization.
- Nasal Congestion Score (NCS) ≥2 at screening (daily average) and randomization (weekly average).
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- Persistent symptoms of rhinorrhea and/or hyposmia/anosmia for over 8 weeks prior to screening.
- 22-item Sino-Nasal Outcome Test (SNOT-22) score ≥30 at screening and randomization.
- Stable dose of intranasal corticosteroids (INCS) for >4 weeks prior to screening (subjects using non-mometasone furoate nasal spray [MFNS] products must agree to switch to Mometasone Furoate Nasal Spray (MFNS) during the study).
- Subjects with comorbid asthma must have had stable asthma symptoms for ≥4 weeks prior to screening (if using medications, such as inhaled corticosteroids, the same dose must have been stably maintained for ≥4 weeks before screening, and the dose is assessed to remain stable during the first phase).
- The evaluation during the lead-in period showed that the medication adherence to intranasal mometasone furoate nasal spray (MFNS) was greater than 70%, and the adherence to daily symptom assessment records in the subjects' electronic logs was also greater than 70%. Note: Days with missing electronic log data were considered non-adherent to this criterion.
- Agreement to practice effective non-pharmacologic contraception from informed consent until 6 months post-final dose, for subjects/partners of childbearing potential.
Who cannot join
- Conditions/Diseases Affecting Efficacy Evaluation
- Nasal septum deviation causing ≥1 nostril obstruction；
- Perforation of the nasal septum
- Acute sinusitis, nasal infection, or upper respiratory infection within 2 weeks pre-screening or during screening/run-in periods；
- Rhinitis medicamentosa；
- Eosinophilic granulomatosis with polyangiitis (EGPA), granulomatosis with polyangiitis (GPA), Young's syndrome, Kartagener's syndrome, other ciliary dyskinesia syndromes, or cystic fibrosis；
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- Suspected or confirmed fungal sinusitis by imaging；
- Prior nasal surgery altering lateral wall structure precluding NPS assessment；
- Nasal malignancies or benign tumors (e.g., papilloma, hemangioma)；
- Any intranasal and/or sinus surgery (including polypectomy) within 6 months prior to screening.
- Uncontrolled epistaxis within 2 months prior to screening.
- Regular use of decongestants (topical or systemic) prior to screening, except for short-term use during endoscopic examinations.
- Patients who have received any of the following treatments prior to randomization:
- Treatment with immunosuppressants (including but not limited to: cyclophosphamide, cyclosporine, interferon gamma, azathioprine, methotrexate, mycophenolate, tacrolimus, Secukinumab) within 8 weeks or 5 half-lives prior to screening (whichever is longer)；
- Treatment with any monoclonal antibodies (including but not limited to: benralizumab, mepolizumab, omalizumab, dupilumab, or other similar drugs [e.g., TSLP blockers]) within 8 weeks or 5 half-lives prior to screening (whichever is longer).
- Patients who used medium- or short-acting systemic corticosteroids (SCS, including oral, intravenous, or intramuscular administration), systemic traditional Chinese medicine preparations for treating CRS within 4 weeks prior to screening, or received long-acting SCS (e.g., triamcinolone acetonide injection) within 6 weeks prior to screening, or who plan to receive the aforementioned medications during the study period.
- Use of corticosteroid-eluting nasal stents within 6 months prior to screening;
- Treatment with immunoglobulins or blood products within 28 days prior to screening;
- Administration of live attenuated vaccines within 28 days prior to screening or planned during the study period;
- Allergen-specific immunotherapy within 6 months prior to screening (allowed only if: initiated >3 months before screening, maintained at a stable dose for ≥1 month before Visit 1, and no planned dose changes during the study)；
- Participation in other drug/medical device clinical trials within 3 months prior to screening (based on last administration/use).
- Use nasal antihistamines (such as olopatadine nasal spray, azelastine nasal spray, levocabastine nasal spray, etc.) for the first 3 days.
- Screening for a history of active pulmonary tuberculosis within the past 12 months；
- Exclusion of infections within the last 14 days requiring systemic antibiotic, antiviral, antifungal, antiparasitic, or antiprotozoal therapy;
- Exclusion of subjects diagnosed with helminthic parasitic infection in the past 6 months who either did not receive standard treatment or had treatment failure；
- Known or suspected history of immunosuppression, immune dysfunction, or immune dysregulation, including but not limited to invasive opportunistic infections (histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis, aspergillosis), even if the infection has resolved; Or there is an unusual frequency, recurrence, or prolonged infection (as judged by the investigator).
- The forced expiratory volume in the first second (FEV1) of the subjects during the screening/introduction period was ≤ 50% of the normal predicted value.
- Patients with comorbid asthma who meet any of the following criteria:
- Asthma exacerbation within 90 days before screening, or current use of inhaled corticosteroids (ICS) at a daily dose higher than 1000μg fluticasone (or equivalent).
- Definition of Asthma Acute Exacerbation:
- Use of systemic corticosteroids (or a temporary increase in the stable dose of baseline OCS) for at least 3 consecutive days due to worsening asthma; a single injection of depot long-acting corticosteroids may be considered equivalent to a 3-day course of systemic corticosteroids.
- An emergency department or urgent care center visit due to asthma requiring systemic corticosteroids (as described above) (defined as evaluation and treatment in the emergency department or urgent care center lasting <24 hours).
- Hospitalization due to asthma (defined as admission to a medical facility and/or evaluation and treatment in a healthcare setting lasting ≥24 hours).
- Use of leukotriene antagonists/modulators prior to randomization (subjects who have been on a stable dose of leukotriene modulators for ≥30 days continuously prior to randomization may be enrolled);
- Presence of other concurrent active or clinically significant respiratory diseases that, in the investigator's judgment, may significantly impact the study, such as active tuberculosis, lung cancer, bronchiectasis, pulmonary sarcoidosis, pulmonary fibrosis, pulmonary hypertension, interstitial lung disease, or other active pulmonary conditions
- Subjects who have undergone lobectomy or lung volume reduction surgery within 12 months prior to the start of the study;
- Exclusion of subjects with cardiovascular conditions (including but not limited to unstable ischemic heart disease, heart failure, uncontrolled hypertension, myocardial infarction, significant arrhythmias, long QT syndrome, or Fridericia-corrected QT interval (QTcF) prolongation [≥450 ms in men, ≥470 ms in women]) if the investigator deems participation could compromise safety or study outcome interpretation;
- Exclude individuals with difficult venous access or a history of vasovagal syncope (needle/blood-related);
- Exclusion of any current active malignancy or history of malignancy (Patients with basal cell carcinoma, localized squamous cell carcinoma of the skin, or carcinoma in situ of the cervix are eligible if curative treatment was completed >12 months before V1. Patients with other malignancies are eligible if curative treatment was completed at least 5 years before V1).
- Presence of active autoimmune diseases (including but not limited to Hashimoto's thyroiditis with hyperthyroidism, Graves' disease, inflammatory bowel disease, primary biliary cholangitis, systemic lupus erythematosus, multiple sclerosis and other neuroinflammatory disorders, psoriasis vulgaris, and rheumatoid arthritis);
- Exclusion if any infectious disease screening indicator meets the following criteria during screening;
- Exclusion of subjects who are positive for hepatitis B virus surface antigen (HBsAg).
- Hepatitis B virus core antibody (HBcAb) with detectable Hepatitis B Virus (HBV)-DNA.
- Exclude if Hepatitis C Virus (HCV) antibody-positive and HCV-RNA positive, or if previously treated for HCV (regardless of current HCV-RNA status).
- Anti-Treponema pallidum antibody (Anti-TP) positive (if syphilis serology is positive, a non-treponemal test must be performed; subjects with a negative non-treponemal test and deemed by the investigator as previously cured are eligible).
- Anti-HIV positive
- Abnormal laboratory test results:
- White blood cell count <3.5 × 10⁹/L;
- Aspartate aminotransferase (AST) >2.5 × upper limit of normal (ULN);
- Alanine aminotransferase (ALT) >2.5 × ULN;
- Total bilirubin >2 × ULN;
- Creatinine >1.5 × ULN
- Any clinically significant abnormal findings during the import period, including physical examination, vital signs, 12-lead ECG, blood biochemistry, hematology, or urinalysis, which in the investigator's judgment may place the patient at risk, affect study results, or impair the patient's ability to complete the entire study
- Women who are pregnant or lactating.
- Those who were still smokers or had quit smoking for less than six months at the time of screening.
- Exclude those with regular excessive alcohol consumption (>14 units/week for females or >21 units/week for males) in the past 6 months, inability to abstain during the trial, or a positive breath alcohol test.
- History of drug abuse within the past 2 years, or a positive drug abuse screening result.
- Subjects with a known history of hypersensitivity or allergic reaction to any ingredient of mometasone furoate nasal spray (Nasonex®) or TQC2731 injection.
- Exclusion for any history of systemic allergic reaction to biologic agents (local injection site reactions excluded).
- The participant demonstrated poor adherence and was deemed unable to complete the study.
- Any medical or psychiatric condition that, in the judgment of the investigator or the sponsor's medical reviewer, may affect the subject's safety throughout the study or impede the subject's ability to complete the entire study process or interfere with the interpretation of study results, including but not limited to cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, hematologic disorders, psychiatric illnesses, or major physical disabilities.
Trial locations and contacts
60 sites in 1 country. Contact the study team or a site near you to ask about taking part.
60 sites in 1 country
China60 sites, 60 recruiting
- Not yet recruiting
Peking University People'S Hospital
Beijing, Beijing Municipality, 100044
Min Wang, Doctor, 13671210353, minwang333@sina.com
- Not yet recruiting
Beijing youan hospital，capital medical university
Beijing, Beijing Municipality, 100069
Shiping Bao, Master, 13901122853, baoshiping@163.com
- Not yet recruiting
Cangzhou Central Hospital
Cangzhou, Hebei, 61012
Weiwei Liu, Master, 13393275339, lwwczbj@163.com
- Not yet recruiting
China-Japan Union Hospital of Jilin University
Changchun, Jilin, 130000
Dongdong Zhu, Doctor, 13578772290, zhudd@jlu.edu.cn
- Not yet recruiting
The first hospital of Jilin University
Changchun, Jilin, 130000
Yusheng Wang, Doctor, 15804300590, entw@vip.163.com
- Not yet recruiting
The First People's Hospital of Changde City
Changde, Hunan, 415000
Zongjing Tong, Master, 15973644112, tongtong0492@126.com
- Not yet recruiting
People's Hospital of Hunan Province
Changsha, Hunan, 410002
Xuping Xiao, Bachelor, 15074869966, Xupingx0720@sina.com
- Not yet recruiting
The Third Xiangya Hospital of Central South University
Changsha, Hunan, 410013
Guolin Tan, Doctor, 13873187823, guolintan@163.com
- Not yet recruiting
West China Hospital of Si chuan University
Chengdu, Sichuan, 610000
Feng Liu, Doctor, 18628979607, 396173028@qq.com
- Not yet recruiting
Chengdu Second People's Hospital
Chengdu, Sichuan, 610017
Dingqiang Huang, Doctor, 15892693338, huangdingq666666@163.com
- Not yet recruiting
Chifeng Municipal Hospital
Chifeng, Inner Mongolia, 24000
Yiqun Zhou, Master, 18747661981, zhouyiqunjin@163.com
- Not yet recruiting
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400016
Yucheng Yang, Doctor, 13452018123, yychxh@163.com
- Not yet recruiting
Affiliated Zhongshan Hospital Of Dalian University
Dalian, Jilin, 116001
Xianhua Li, Bachelor, 15542382703, lixh6210@163.com
- Not yet recruiting
Daqing People's Hospital
Daqing, Heilongjiang, 163316
Yufen Xin, Master, 13845943072, xinyufen1968@163.com
- Not yet recruiting
Fengcheng People's Hospital
Fengcheng, Jiangxi, 331100
Mingliang Lai, Bachelor, 13607057293, m13607057293_1@163.com
- Not yet recruiting
Zhongda Hosiptal Southeast University
Fuyang, Anhui, 236600
Hui Wang, Bachelor, 13615676587, 316040328@qq.com
- Not yet recruiting
Ganzhou People's Hospital
Ganzhou, Jiangxi, 341000
Xintao Wang, Master, 13767794280, 391112745@qq.com
- Not yet recruiting
The Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510405
Fenghong Chen, Doctor, 13560170816, 13560170816@163.com
- Not yet recruiting
Affilited hangzhou first people's hospital, school of medicine, westlakeuniversity
Hangzhou, Zhejiang, 310006
Xiaolin Cao, Master, 13958001343, doctorcaoxiaolin@163.com
- Not yet recruiting
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, 310014
Weiming Hu, Doctor, 13588426686, huwm93@163.com
- Not yet recruiting
The Second Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230601
Jianming Yang, Doctor, 13339100005, Jmyang88@163.com
- Not yet recruiting
Affiliated Hospital of Inner Mongolia Medical University
Hohhot, Inner Mongolia, 10000
Xiaobo Cui, Doctor, 18686024380, cxbgh@sina.com
- Not yet recruiting
Shandong Second Province General Hospital
Jinan, Shandong, 250021
Li Shi, Doctor, 13791122810, shili126@sina.com
- Not yet recruiting
Jingzhou Central Hospital
Jingzhou, Hubei, 434000
Lijia Wan, Master, 18972160068, 949222808@qq.com
- Not yet recruiting
The First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, 650032
Yongmei Yu, Master, 13888532131, yuyongmei@qq.com
- Not yet recruiting
Hebei Petro China Central Hospital
Langfang, Hebei, 650000
Jianbin Li, Bachelor, 13785658534, caoyu200211@souhu.com
- Not yet recruiting
The 940th Hospital of Joint Logistics Support force of Chinese People 's Liberation Army
Lanzhou, Gansu, 730050
Cuiping Zhong, Doctor, 13893651909, doctorzhongcp@163.com
- Not yet recruiting
The First People'S Hospital of Lianyungang
Lianyungang, Jiangsu, 222000
Chunguang Dong, Bachelor, 18961326297, 18961326297@189.cn
- Not yet recruiting
Linfen Central Hospital
Lifen, Shanxi, 041000
Lulu Zhu, Bachelor, 15135369845, 1070462593@qq.com
- Not yet recruiting
Liuzhou People's Hospital
Liuzhou, Guangxi, 545200
Binyu Mo, Master, 18577264277, 124725112@qq.com
- Not yet recruiting
The First Affiliated Hospital of NanChang University
Nanchang, Jiangxi, 330006
Jing Ye, Doctor, 13979161109, yjholly@qq.com
- Not yet recruiting
Zhongda Hospital affiliated to Southeast University
Nanjing, Jiangsu, 210009
Zhichun Huang, Master, 13776690985, huang1963618@sohu.com
- Not yet recruiting
The First Affiliated Hospital of Ningbo University
Ningbo, Zhejiang, 315000
Yaowen Wang, Doctor, 13867867009, wangyaowennihao@hotmail.com
- Not yet recruiting
Ningbo No.2 Hospital
Ningbo, Zhejiang, 315010
Jiyun Wang, Doctor, 13486690191, wjiyun2008@163.com
- Not yet recruiting
Qingdao Municipal Hospital
Qingdao, Shandong, 266000
Mingjie Pang, Master, 18561728116, pangmingjie@sina.com
- Recruiting
Eye&ENT Hospital of Fudan University
Shanghai, Shanghai Municipality, 200031
Dehui Wang, Doctor, 13701852008, wangdehuient@sina.com
- Not yet recruiting
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200032
Xinsheng Huang, Doctor, 13681971739, huang.xinsheng@zs-hospital.sh.cn
- Not yet recruiting
Renji Hospital,Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200127
Jiping Li, Doctor, 13764089841, drlijiping@163.com
- Not yet recruiting
Shanghai Sixth People's Hospital
Shanghai, Shanghai Municipality, 200233
Haibo Shi, Doctor, 18930177657, haibo99@hotmail.com
- Not yet recruiting
ShangRao People's Hospital
Shangrao, Jiangxi, 334000
Wei Hong, Bachelor, 13807939522, h5969w@163.com
- Not yet recruiting
China Medical University Affiliated Shengjing Hospital
Shenyang, Liaoning, 110004
Zhiwei Cao, Doctor, 18940251770, czw18940251770@163.com
- Not yet recruiting
Shenzhen Second People'S Hospital
Shenzhen, Guangdong, 518035
Beiping Miao, Doctor, 13923765937, miaobeiping@163.com
- Not yet recruiting
Hebei Medical University Third Hospital
Shijiazhuang, Hebei, 065799
Feng Luan, Master, 18533112937, luanfengly@163.com
- Not yet recruiting
First Hospital of Shanxi Medical University
Taiyuan, Shanxi, 030045
Xiangbin Chai, Doctor, 15135193199
- Not yet recruiting
Taizhou First People's Hospital
Taizhou, Zhejiang, 318020
Xuejun Li, Bachelor, 15868699100, johnsnowly@aliyun.com
- Not yet recruiting
Tianjin First Central Hospital
Tianjin, Tianjin Municipality, 300190
Wei Wang, Master, 13802120366, wwei1106@hotmail.com
- Not yet recruiting
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, 830000
Yuping Yang, Doctor, 13999984998, 978288587@qq.com
- Not yet recruiting
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430022
Jianjun Chen, Doctor, 13659851719, Y11y80331@163.com
- Not yet recruiting
Jiangnan University Medical Center
Wuxi, Jiangsu, 214000
Guijuan Xie, Master, 13915270308, summer111.good@163.com
- Not yet recruiting
The Second Affiliated Hospital Of Xi'an Jiaotong University
Xi'an, Shaanxi, 710004
Kang Zhu, Master, 18991341809, zhukangent@163.com
- Not yet recruiting
The First Affiliated Hospital of Xi'an Jiao Tong University
Xi'an, Shaanxi, 710061
Fang Quan, Doctor, 13572056056, quanfang2013@163.com
- Not yet recruiting
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, 361000
Xianyang Luo, Master, 13806082531, Lxy701@126.com
- Not yet recruiting
Yan'an University Xianyang Hospital
Xianyang, Shaanxi, 712000
Ligang Zhang, Master, 15891651067, ligangzhang79@126.com
- Not yet recruiting
Xuzhou Medical University Affiliated Hospital
Xuzhou, Jiangsu, 221000
Wen Liu, Doctor, 13615102636, liuwen1972@163.com
- Not yet recruiting
Affiliated Hospital of Yangzhou Univrtsity
Yangzhou, Jiangsu, 225000
Guang Li, Doctor, 13773597188, entliguang@163.com
- Not yet recruiting
Yantai Yuhuangding Hospital
Yantai, Shandong, 264000
Xicheng Song, Doctor, 18005350077, drxchsong@163.com
- Not yet recruiting
Yuncheng Central Hospital，Shanxi Province
Yuncheng, Shanxi, 44099
Jun Ren, Master, 18935096870, 306901253@qq.com
- Not yet recruiting
The First Affiliated Hospital of Hebei North University
Zhangjiakou, Hebei, 75000
Xiaoling Shang, Bachelor, 15530396553, shenbao2019@126.com
- Not yet recruiting
Henan Provincial People'S Hospital
Zhengzhou, Henan, 450003
Guangke Wang, Bachelor, 13598895398, 13598895398@163.com
- Not yet recruiting
Zibo Central Hospital
Zibo, Shandong, 255020
Daoliang Song, Master, 18678186682, songdaoliang1971@163.com
About this study
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Phase III Clinical Trial to Evaluate the Efficacy and Safety of TQC2731 Injection in Patients With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
TQC2731 injection is a humanized monoclonal antibody that targets Thymic Stromal Lymphopoietin (TSLP), blocks the TSLP pathway, and inhibits the production of downstream cytokines, thereby exerting anti-inflammatory effects. The purpose of this study is to evaluate the efficacy and safety of TQC2731 injection in patients with chronic rhinosinusitis with nasal polyps (CRSwNP).
- Being tested
- TQC2731 injection, Placebo of TQC2731
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 humanized monoclonal antibody that targets TSLP, blocks the TSLP signaling pathway, inhibits the production of downstream cytokines, and exerts anti-inflammatory effects.
Placebo of TQC2731Drug
TQC2731 injection is a humanized monoclonal antibody that targets TSLP, blocks the TSLP signaling pathway, inhibits the production of downstream cytokines, and exerts anti-inflammatory effects.
| Study group | Role | What they receive |
|---|---|---|
| TQC2731 injection | Active comparator | TQC2731 injection/placebo，4 weeks as a treatment cycle. Receives: Drug: TQC2731 injection |
| Placebo of TQC2731 | Placebo comparator | TQC2731 injection/placebo，4 weeks as a treatment cycle. Receives: Drug: Placebo of TQC2731 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nasal Polyp Score (NPS)
Change in Nasal Polyp Score (NPS) from baseline to Week 24 in CRSwNP subjects.
Measured: From baseline to Week 24
Nasal Congestion Score (NCS)
Change in Nasal Congestion Score (NCS) from baseline to Week 24 in CRSwNP subjects
Measured: From baseline to Week 24
Change in nasal polyp score (NPS) from baseline
Change in nasal polyp score (NPS) from baseline at week 24 in ECRSwNP subjects.
Measured: From baseline to Week 24
Change from baseline in Nasal Congestion Score (NCS)
Change from baseline in Nasal Congestion Score (NCS) at Week 24 in ECRSwNP subjects
Measured: From baseline to Week 24
Secondary outcomes (19)
Lund-Mackay score
The change in Lund-Mackay score from baseline for the subject's CT scan at week 24. The higher the score, the more severe the CRS condition.
Measured: From baseline to Week 24
Olfactory loss score
The change in anosmia score assessed in the electronic logs of subjects at each visit point relative to baseline. A reduction in the olfactory loss score implies therapeutic efficacy or ongoing recovery.
Measured: From baseline to Week 60
22-item Sino-Nasal Outcome Test (SNOT-22) score
The change from baseline in the 22-item Sino-Nasal Outcome Test (SNOT-22) score at each visit.
Measured: From baseline to Week 60
Total Symptom Score (TSS)
The change in Total Symptom Score (TSS) from baseline at each visit point for the subjects.
A reduction in the Total Nasal Symptom Score (TSS) post-treatment suggests effective therapeutic response.
Measured: From baseline to Week 60
Visual Analog Scale (VAS)
Visual Analog Scale (VAS) overall score changes for sinusitis relative to baseline at each visit point for subjects.
A higher VAS score indicates a greater impact of sinusitis on the subject's quality of life.
Measured: From baseline to Week 60
The proportion of subjects receiving systemic corticosteroid (SCS) rescue or nasal polyp (NP) surgery
The proportion of subjects receiving systemic corticosteroid (SCS) rescue or nasal polyp (NP) surgery during the 24-week double-blind treatment period
Measured: From baseline to Week 24
Time to systemic corticosteroid (SCS) rescue therapy or nasal polyp (NP) surgery
Time to systemic corticosteroid (SCS) rescue therapy or nasal polyp (NP) surgery during the 24-week double-blind treatment period.
Measured: From baseline to Week 24
Numbers of participants with adverse events (AEs) and abnormal laboratory test results
Evaluate the safety of TQC2731 in subjects with CRSwNP, including abnormalities such as adverse events (AEs), laboratory tests, physical examinations, vital signs, and 12-lead electrocardiogram (ECG).
Measured: From baseline until 30 days after the last dose
Incidence of anti-drug antibodies (ADA)
Incidence of anti-drug antibodies (ADA)
Measured: 2 hours pre-dose in Day 1, Day 57, Day 169, Day 253, Day 365, Day 421 and at the time of withdrawal
Incidence of neutralizing antibodies (Nab)
Incidence of neutralizing antibodies (Nab)
Measured: 2 hours pre-dose in Day 1, Day 57, Day 169, Day 253, Day 365, Day 421 and at the time of withdrawal
Blood eosinophil count
Evaluate the changes from baseline in blood eosinophil count at each visit point.
Measured: 2 hours pre-dose in Day 1, Day 169, Day 365, Day 421 and at the time of withdrawal
Total Immunoglobulin E (IgE) concentration
Evaluate the changes from baseline in peripheral blood total IgE at each visit point.
Measured: 2 hours pre-dose in Day 1, Day 169, Day 365, Day 421 and at the time of withdrawal
Nasal biopsy tissue eosinophil levels
Evaluate the changes from baseline in nasal biopsy tissue eosinophil levels at each visit point.
Measured: 2 hours pre-dose in Day 1, Day 169, Day 365, Day 421 and at the time of withdrawal
Change in nonECRSwNP nasal polyp score (NPS) from baseline
Change in nonECRSwNP nasal polyp score (NPS) from baseline at Week 24
Measured: From baseline to Week 24
The change from baseline in nonECRSwNP nasal congestion score (NCS)
The change from baseline in nonECRSwNP nasal congestion score (NCS) at week 24
Measured: Week 24
The percentage of subjects with an NPS score improvement of ≥1 point from baseline
The percentage of subjects with an NPS score improvement of ≥1 point from baseline at each evaluation visit point.
Measured: Baseline through week 60
The percentage of subjects with an NPS score improvement of ≥2 points from baseline
The percentage of subjects with an NPS score improvement of ≥2 points from baseline at each evaluation visit point.
Measured: Baseline through week 60
The percentage of subjects with an improvement of ≥1 point in NCS score compared to baseline
The percentage of subjects with an improvement of ≥1 point in NCS score compared to baseline at each evaluation visit point.
Measured: Baseline through week 60
The percentage of subjects with an improvement of ≥2 points in NCS score
The percentage of subjects with an improvement of ≥2 points in NCS score at each evaluation visit compared to baseline.
Measured: Baseline through week 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2025
- Study start25 Sep 2025
- Primary completionMar 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)Studies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 246 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07107256
- Sponsor's protocol ID
- TQC2731-III-02
- Status last verified
- Apr 2025
- First submitted
- 23 Jul 2025
- Last updated
- 16 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No