Actively Recruiting
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Safety and Efficacy of TQC2731 Injection in Patients with Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)
Led by Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd. · Updated on 2025-12-16
246
Participants Needed
60
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying TQC2731 injection, a humanized monoclonal antibody that targets Thymic Stromal Lymphopoietin (TSLP) to block its pathway and reduce inflammation. This clinical trial focuses on patients with chronic rhinosinusitis with nasal polyps (CRSwNP) to evaluate the safety and effectiveness of TQC2731 injection. Participants will receive either TQC2731 injection or a placebo in treatment cycles lasting 4 weeks. The study is randomized, double-blind, and placebo-controlled, with repeated treatment cycles. The effects on nasal polyp size and nasal congestion will be assessed over a 24-week period, with additional measures taken up to 60 weeks. During the trial, participants will undergo nasal endoscopy to score nasal polyps and congestion, complete symptom questionnaires, and have blood and nasal tissue samples collected at various points. Safety monitoring includes tracking adverse events and immune response tests. The study duration extends to 60 weeks to evaluate long-term outcomes and treatment impact.
CONDITIONS
Brief 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 showing understanding of the trial and potential risks
- Age between 18 and 75 years at the time of consent
- Diagnosis of bilateral chronic rhinosinusitis with nasal polyps according to Chinese guidelines
- At least one prior course of systemic corticosteroids within 2 years, or contraindication/intolerance to corticosteroids, or prior nasal polyp surgery over 6 months ago
- Bilateral nasal polyp score of 5 or higher with at least 2 points per nostril
- Nasal congestion score of 2 or higher at screening and randomization
- Persistent symptoms of rhinorrhea and/or smell loss for more than 8 weeks
- 22-item Sino-Nasal Outcome Test (SNOT-22) score of 30 or higher
- Stable dose of intranasal corticosteroids for more than 4 weeks prior to screening
- Stable asthma symptoms for at least 4 weeks if comorbid asthma
- Medication adherence greater than 70% for nasal spray and symptom record logs
- Agreement to use effective contraception during and for 6 months after the study
You will not qualify if you...
- Nasal septum deviation causing obstruction or nasal septum perforation
- Acute sinusitis, nasal infection, or upper respiratory infection within 2 weeks before screening
- Rhinitis medicamentosa
- Specific immune or ciliary disorders such as EGPA, GPA, Young's syndrome, Kartagener's syndrome, cystic fibrosis
- Suspected or confirmed fungal sinusitis
- Prior nasal surgery altering lateral wall structure preventing polyp scoring
- Nasal malignancies or benign tumors
- Intranasal or sinus surgery within 6 months before screening
- Uncontrolled nosebleeds within 2 months before screening
- Regular use of decongestants prior to screening except short-term use during exams
- Recent use of immunosuppressants or monoclonal antibodies within 8 weeks prior to screening
- Recent systemic corticosteroids or corticosteroid-eluting nasal stents within defined periods
- Recent immunoglobulins, blood products, live vaccines, or allergen immunotherapy
- Participation in other trials within 3 months before screening
- History of active tuberculosis within 12 months
- Recent infections requiring systemic treatments
- Helminthic parasitic infection untreated or failed treatment in past 6 months
- Known or suspected immunosuppression or immune dysfunction
- Lung function (FEV1) less than or equal to 50% predicted
- Recent asthma exacerbations or high-dose inhaled corticosteroid use
- Significant other respiratory diseases or recent lung surgeries
- Certain cardiovascular conditions
- Difficult venous access or history of vasovagal syncope
- Current or recent malignancies except certain skin or cervical cancers with specific timing
- Active autoimmune diseases
- Positive tests for specific infections including hepatitis B, C, syphilis, or HIV
- Abnormal lab test results exceeding defined limits
- Clinically significant abnormal physical or lab findings
- Pregnant or breastfeeding women
- Current smokers or quit less than 6 months ago
- Excessive alcohol use or inability to abstain during trial
- Recent drug abuse or positive drug screening
- History of allergic reactions to study drugs or biologics
- Poor adherence or inability to complete the study
- Medical or psychiatric conditions affecting safety or study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 weeks
Participants receive TQC2731 injection or placebo in 4-week treatment cycles.
Visits occur throughout the 24-week treatment period to monitor safety and efficacy
Duration - Up to 36 weeks after treatment (through Week 60)
Participants are monitored for safety and long-term outcomes after the treatment period.
Scheduled visits for assessments up to Week 60 after baseline
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
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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