Clinical Trial of TQC2731 Injection in Patients With Chronic Sinusitis and Nasal Polyps
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)
1 other identifier
interventional
246
1 country
60
Brief 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. The purpose of this study is to evaluate the efficacy and safety of TQC2731 injection in patients with chronic rhinosinusitis with nasal polyps (CRSwNP).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Sep 2025
60 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 23, 2025
CompletedFirst Posted
Study publicly available on registry
August 6, 2025
CompletedStudy Start
First participant enrolled
September 25, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2027
December 16, 2025
April 1, 2025
1.4 years
July 23, 2025
December 9, 2025
Conditions
Outcome Measures
Primary Outcomes (4)
Nasal Polyp Score (NPS)
Change in Nasal Polyp Score (NPS) from baseline to Week 24 in CRSwNP subjects.
From baseline to Week 24
Nasal Congestion Score (NCS)
Change in Nasal Congestion Score (NCS) from baseline to Week 24 in CRSwNP subjects
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.
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
From baseline to Week 24
Secondary Outcomes (19)
Lund-Mackay score
From baseline to Week 24
Olfactory loss score
From baseline to Week 60
22-item Sino-Nasal Outcome Test (SNOT-22) score
From baseline to Week 60
Total Symptom Score (TSS)
From baseline to Week 60
Visual Analog Scale (VAS)
From baseline to Week 60
- +14 more secondary outcomes
Study Arms (2)
TQC2731 injection
ACTIVE COMPARATORTQC2731 injection/placebo，4 weeks as a treatment cycle.
Placebo of TQC2731
PLACEBO COMPARATORTQC2731 injection/placebo，4 weeks as a treatment cycle.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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).
- Persistent symptoms of rhinorrhea and/or hyposmia/anosmia for over 8 weeks prior to screening.
- 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.
You may not qualify if:
- 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；
- 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).
- +39 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (60)
Zhongda Hosiptal Southeast University
Fuyang, Anhui, 236600, China
The Second Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230601, China
Peking University People'S Hospital
Beijing, Beijing Municipality, 100044, China
Beijing youan hospital，capital medical university
Beijing, Beijing Municipality, 100069, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400016, China
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, 361000, China
The 940th Hospital of Joint Logistics Support force of Chinese People 's Liberation Army
Lanzhou, Gansu, 730050, China
The Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510405, China
Shenzhen Second People'S Hospital
Shenzhen, Guangdong, 518035, China
Liuzhou People's Hospital
Liuchow, Guangxi, 545200, China
Cangzhou Central Hospital
Cangzhou, Hebei, 61012, China
Hebei Petro China Central Hospital
Langfang, Hebei, 650000, China
Hebei Medical University Third Hospital
Shijiazhuang, Hebei, 065799, China
The First Affiliated Hospital of Hebei North University
Zhangjiakou, Hebei, 75000, China
Daqing People's Hospital
Daqing, Heilongjiang, 163316, China
Henan Provincial People'S Hospital
Zhengzhou, Henan, 450003, China
Jingzhou Central Hospital
Jingzhou, Hubei, 434000, China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430022, China
The First People's Hospital of Changde City
Changde, Hunan, 415000, China
People's Hospital of Hunan Province
Changsha, Hunan, 410002, China
The Third Xiangya Hospital of Central South University
Changsha, Hunan, 410013, China
Chifeng Municipal Hospital
Chifeng, Inner Mongolia, 24000, China
Affiliated Hospital of Inner Mongolia Medical University
Hohhot, Inner Mongolia, 10000, China
The First People'S Hospital of Lianyungang
Lianyungang, Jiangsu, 222000, China
Zhongda Hospital affiliated to Southeast University
Nanjing, Jiangsu, 210009, China
Jiangnan University Medical Center
Wuxi, Jiangsu, 214000, China
Xuzhou Medical University Affiliated Hospital
Xuzhou, Jiangsu, 221000, China
Affiliated Hospital of Yangzhou Univrtsity
Yangzhou, Jiangsu, 225000, China
Fengcheng People's Hospital
Fengcheng, Jiangxi, 331100, China
Ganzhou People's Hospital
Ganzhou, Jiangxi, 341000, China
The First Affiliated Hospital of NanChang University
Nanchang, Jiangxi, 330006, China
ShangRao People's Hospital
Shangrao, Jiangxi, 334000, China
China-Japan Union Hospital of Jilin University
Changchun, Jilin, 130000, China
The first hospital of Jilin University
Changchun, Jilin, 130000, China
Affiliated Zhongshan Hospital Of Dalian University
Dalian, Jilin, 116001, China
China Medical University Affiliated Shengjing Hospital
Shenyang, Liaoning, 110004, China
The Second Affiliated Hospital Of Xi'an Jiaotong University
Xi'an, Shaanxi, 710004, China
The First Affiliated Hospital of Xi'an Jiao Tong University
Xi'an, Shaanxi, 710061, China
Yan'an University Xianyang Hospital
Xianyang, Shaanxi, 712000, China
Shandong Second Province General Hospital
Jinan, Shandong, 250021, China
Qingdao Municipal Hospital
Qingdao, Shandong, 266000, China
Yantai Yuhuangding Hospital
Yantai, Shandong, 264000, China
Zibo Central Hospital
Zibo, Shandong, 255020, China
Eye&ENT Hospital of Fudan University
Shanghai, Shanghai Municipality, 200031, China
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200032, China
Renji Hospital,Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200127, China
Shanghai Sixth People's Hospital
Shanghai, Shanghai Municipality, 200233, China
Linfen Central Hospital
Lifen, Shanxi, 041000, China
First Hospital of Shanxi Medical University
Taiyuan, Shanxi, 030045, China
Yuncheng Central Hospital，Shanxi Province
Yuncheng, Shanxi, 44099, China
West China Hospital of Si chuan University
Chengdu, Sichuan, 610000, China
Chengdu Second People's Hospital
Chengdu, Sichuan, 610017, China
Tianjin First Central Hospital
Tianjin, Tianjin Municipality, 300190, China
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, 830000, China
The First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, 650032, China
Affilited hangzhou first people's hospital, school of medicine, westlakeuniversity
Hangzhou, Zhejiang, 310006, China
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, 310014, China
The First Affiliated Hospital of Ningbo University
Ningbo, Zhejiang, 315000, China
Ningbo No.2 Hospital
Ningbo, Zhejiang, 315010, China
Taizhou First People's Hospital
Taizhou, Zhejiang, 318020, China
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 23, 2025
First Posted
August 6, 2025
Study Start
September 25, 2025
Primary Completion (Estimated)
March 1, 2027
Study Completion (Estimated)
September 1, 2027
Last Updated
December 16, 2025
Record last verified: 2025-04