Actively Recruiting
Clinical Trial of TQC2731 Injection in Patients With Chronic Sinusitis and Nasal Polyps
Led by Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd. · Updated on 2025-12-16
246
Participants Needed
60
Research Sites
100 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Clinical Trial of TQC2731 Injection in Patients With Chronic Sinusitis and Nasal Polyps
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent before participating in the trial.
- Age between 18 and 75 years inclusive.
- Diagnosed with bilateral chronic rhinosinusitis with nasal polyps according to Chinese guidelines.
- Have had at least one course of systemic corticosteroids within 2 years before screening, or have contraindications or intolerance to systemic corticosteroids, or had prior nasal polyp surgery more than 6 months before screening.
- Bilateral Nasal Polyp Score of 5 or higher with at least 2 points per nostril by nasal endoscopy.
- Nasal Congestion Score of 2 or higher at screening and randomization.
- Persistent symptoms of runny nose and/or reduced or lost sense of smell for over 8 weeks before screening.
- Sino-Nasal Outcome Test (SNOT-22) score of 30 or more at screening and randomization.
- Stable dose of intranasal corticosteroids for more than 4 weeks before screening (switch to mometasone furoate nasal spray if using other types).
- Stable asthma symptoms for at least 4 weeks before screening if asthma is present.
- Medication adherence over 70% for mometasone furoate nasal spray and daily symptom records during lead-in period.
- Agreement to use effective non-drug contraception from consent until 6 months after final dose for those with childbearing potential.
You will not qualify if you...
- Nasal septum deviation causing obstruction in one nostril.
- Nasal septum perforation.
- Acute sinusitis, nasal infection, or upper respiratory infection within 2 weeks before or during screening.
- Rhinitis medicamentosa.
- Certain rare diseases like eosinophilic granulomatosis with polyangiitis, granulomatosis with polyangiitis, Young's syndrome, Kartagener's syndrome, ciliary dyskinesia syndromes, or cystic fibrosis.
- Suspected or confirmed fungal sinusitis.
- Prior nasal surgery changing lateral wall structure preventing polyp scoring.
- Nasal malignancies or benign tumors.
- Any nasal or sinus surgery within 6 months before screening.
- Uncontrolled nosebleeds within 2 months before screening.
- Regular use of decongestants before screening except short-term during endoscopy.
- Recent use of immunosuppressants or monoclonal antibodies within 8 weeks before screening.
- Recent use of systemic corticosteroids or traditional Chinese medicine for CRS within specific timeframes before screening.
- Use of corticosteroid nasal stents within 6 months before screening.
- Recent immunoglobulin or blood product treatments.
- Recent live attenuated vaccines.
- Recent allergen immunotherapy unless stable and started more than 3 months before screening.
- Participation in other clinical trials within 3 months before screening.
- Use of nasal antihistamines for first 3 days.
- History of active pulmonary tuberculosis within past 12 months.
- Recent infections requiring systemic anti-infective treatments.
- Recent or untreated parasitic infections.
- History or suspicion of immune disorders or unusual infections.
- Lung function with FEV1 less than or equal to 50% of predicted.
- Asthma exacerbation or high-dose inhaled corticosteroids use before screening.
- Use of leukotriene antagonists unless stable for 30 days before randomization.
- Other active significant respiratory diseases.
- Recent lung surgeries.
- Certain cardiovascular conditions if participation risks safety.
- Difficult venous access or history of needle-related fainting.
- Current or recent malignancies except certain skin or cervical cancers adequately treated.
- Active autoimmune diseases including thyroid, bowel, neurological, skin, or joint disorders.
- Positive tests for certain infections including hepatitis B, C, syphilis, and HIV.
- Abnormal lab results beyond specified limits.
- Significant abnormal physical or lab findings affecting safety or study completion.
- Pregnancy or breastfeeding.
- Current smokers or quit less than 6 months ago.
- Excessive alcohol use recently or inability to abstain during study.
- Recent drug abuse or positive drug tests.
- Known allergies to study drugs or ingredients.
- History of systemic allergic reactions to biological agents.
- Poor adherence or inability to complete the study.
- Medical or psychiatric conditions that could affect safety, study results, or ability to complete the study.
AI-Screening
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Trial Site Locations
Total: 60 locations
1
Zhongda Hosiptal Southeast University
Fuyang, Anhui, China, 236600
Not Yet Recruiting
2
The Second Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China, 230601
Not Yet Recruiting
3
Peking University People'S Hospital
Beijing, Beijing Municipality, China, 100044
Not Yet Recruiting
4
Beijing youan hospital，capital medical university
Beijing, Beijing Municipality, China, 100069
Not Yet Recruiting
5
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China, 400016
Not Yet Recruiting
6
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China, 361000
Not Yet Recruiting
7
The 940th Hospital of Joint Logistics Support force of Chinese People 's Liberation Army
Lanzhou, Gansu, China, 730050
Not Yet Recruiting
8
The Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China, 510405
Not Yet Recruiting
9
Shenzhen Second People'S Hospital
Shenzhen, Guangdong, China, 518035
Not Yet Recruiting
10
Liuzhou People's Hospital
Liuzhou, Guangxi, China, 545200
Not Yet Recruiting
11
Cangzhou Central Hospital
Cangzhou, Hebei, China, 61012
Not Yet Recruiting
12
Hebei Petro China Central Hospital
Langfang, Hebei, China, 650000
Not Yet Recruiting
13
Hebei Medical University Third Hospital
Shijiazhuang, Hebei, China, 065799
Not Yet Recruiting
14
The First Affiliated Hospital of Hebei North University
Zhangjiakou, Hebei, China, 75000
Not Yet Recruiting
15
Daqing People's Hospital
Daqing, Heilongjiang, China, 163316
Not Yet Recruiting
16
Henan Provincial People'S Hospital
Zhengzhou, Henan, China, 450003
Not Yet Recruiting
17
Jingzhou Central Hospital
Jingzhou, Hubei, China, 434000
Not Yet Recruiting
18
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430022
Not Yet Recruiting
19
The First People's Hospital of Changde City
Changde, Hunan, China, 415000
Not Yet Recruiting
20
People's Hospital of Hunan Province
Changsha, Hunan, China, 410002
Not Yet Recruiting
21
The Third Xiangya Hospital of Central South University
Changsha, Hunan, China, 410013
Not Yet Recruiting
22
Chifeng Municipal Hospital
Chifeng, Inner Mongolia, China, 24000
Not Yet Recruiting
23
Affiliated Hospital of Inner Mongolia Medical University
Hohhot, Inner Mongolia, China, 10000
Not Yet Recruiting
24
The First People'S Hospital of Lianyungang
Lianyungang, Jiangsu, China, 222000
Not Yet Recruiting
25
Zhongda Hospital affiliated to Southeast University
Nanjing, Jiangsu, China, 210009
Not Yet Recruiting
26
Jiangnan University Medical Center
Wuxi, Jiangsu, China, 214000
Not Yet Recruiting
27
Xuzhou Medical University Affiliated Hospital
Xuzhou, Jiangsu, China, 221000
Not Yet Recruiting
28
Affiliated Hospital of Yangzhou Univrtsity
Yangzhou, Jiangsu, China, 225000
Not Yet Recruiting
29
Fengcheng People's Hospital
Fengcheng, Jiangxi, China, 331100
Not Yet Recruiting
30
Ganzhou People's Hospital
Ganzhou, Jiangxi, China, 341000
Not Yet Recruiting
31
The First Affiliated Hospital of NanChang University
Nanchang, Jiangxi, China, 330006
Not Yet Recruiting
32
ShangRao People's Hospital
Shangrao, Jiangxi, China, 334000
Not Yet Recruiting
33
China-Japan Union Hospital of Jilin University
Changchun, Jilin, China, 130000
Not Yet Recruiting
34
The first hospital of Jilin University
Changchun, Jilin, China, 130000
Not Yet Recruiting
35
Affiliated Zhongshan Hospital Of Dalian University
Dalian, Jilin, China, 116001
Not Yet Recruiting
36
China Medical University Affiliated Shengjing Hospital
Shenyang, Liaoning, China, 110004
Not Yet Recruiting
37
The Second Affiliated Hospital Of Xi'an Jiaotong University
Xi'an, Shaanxi, China, 710004
Not Yet Recruiting
38
The First Affiliated Hospital of Xi'an Jiao Tong University
Xi'an, Shaanxi, China, 710061
Not Yet Recruiting
39
Yan'an University Xianyang Hospital
Xianyang, Shaanxi, China, 712000
Not Yet Recruiting
40
Shandong Second Province General Hospital
Jinan, Shandong, China, 250021
Not Yet Recruiting
41
Qingdao Municipal Hospital
Qingdao, Shandong, China, 266000
Not Yet Recruiting
42
Yantai Yuhuangding Hospital
Yantai, Shandong, China, 264000
Not Yet Recruiting
43
Zibo Central Hospital
Zibo, Shandong, China, 255020
Not Yet Recruiting
44
Eye&ENT Hospital of Fudan University
Shanghai, Shanghai Municipality, China, 200031
Actively Recruiting
45
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, China, 200032
Not Yet Recruiting
46
Renji Hospital,Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China, 200127
Not Yet Recruiting
47
Shanghai Sixth People's Hospital
Shanghai, Shanghai Municipality, China, 200233
Not Yet Recruiting
48
Linfen Central Hospital
Lifen, Shanxi, China, 041000
Not Yet Recruiting
49
First Hospital of Shanxi Medical University
Taiyuan, Shanxi, China, 030045
Not Yet Recruiting
50
Yuncheng Central Hospital，Shanxi Province
Yuncheng, Shanxi, China, 44099
Not Yet Recruiting
51
West China Hospital of Si chuan University
Chengdu, Sichuan, China, 610000
Not Yet Recruiting
52
Chengdu Second People's Hospital
Chengdu, Sichuan, China, 610017
Not Yet Recruiting
53
Tianjin First Central Hospital
Tianjin, Tianjin Municipality, China, 300190
Not Yet Recruiting
54
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, China, 830000
Not Yet Recruiting
55
The First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, China, 650032
Not Yet Recruiting
56
Affilited hangzhou first people's hospital, school of medicine, westlakeuniversity
Hangzhou, Zhejiang, China, 310006
Not Yet Recruiting
57
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, China, 310014
Not Yet Recruiting
58
The First Affiliated Hospital of Ningbo University
Ningbo, Zhejiang, China, 315000
Not Yet Recruiting
59
Ningbo No.2 Hospital
Ningbo, Zhejiang, China, 315010
Not Yet Recruiting
60
Taizhou First People's Hospital
Taizhou, Zhejiang, China, 318020
Not Yet Recruiting
Research Team
D
Dehui Wang, Doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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