A Clinical Study of TQC2731 Injection in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Clinical Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of TQC2731 Injection in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease
1 other identifier
interventional
258
1 country
60
Brief Summary
To evaluate the efficacy and safety of TQC2731 injection in patients with moderate to severe chronic obstructive pulmonary disease.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 chronic-obstructive-pulmonary-disease
Started Dec 2024
Typical duration for phase_2 chronic-obstructive-pulmonary-disease
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
November 25, 2024
CompletedFirst Posted
Study publicly available on registry
November 27, 2024
CompletedStudy Start
First participant enrolled
December 31, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2027
December 12, 2025
November 1, 2025
1.9 years
November 25, 2024
December 10, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Annual rate of acute COPD exacerbation
Annualized rate of moderate or severe COPD exacerbations over the 24-week treatment period compared to placebo
Baseline to week 24
Secondary Outcomes (12)
Change in pre-bronchodilator forced expiratory volume (FEV1)
Baseline to week 24
Annual rate of acute COPD exacerbation
Baseline to week 52
Improvement in St. George's Respiratory Questionnaire (SGRQ)
Baseline to week 52
Change in SGRQ
Baseline to week 52
Change in pre-bronchodilator FEV1
Baseline to week 52
- +7 more secondary outcomes
Study Arms (2)
TQC2731 injection
EXPERIMENTALTQC2731 injection, 28days as a treatment cycle.
TQC2731 Placebo
PLACEBO COMPARATORTQC2731 Placebo, 28days as a treatment cycle.
Interventions
TQC2731 injection is a monoclonal antibody that blocks thymic stromal lymphopoietin (TSLP)
Eligibility Criteria
You may qualify if:
- Able and willing to provide written informed consent and comply with the study protocol;
- Participant must be ≥40 to ≤80 years of age at the time of signing informed consent.
- Participants with a physician diagnosis of Chronic Obstructive Pulmonary Disease(COPD) and a history of COPD ≥12 months with medical records or related records at the time of screening;
- Post-bronchodilator FEV1/Forced vital capacity (FVC)\<0.70 and post-bronchodilator FEV1 % predicted ≥20% and \< 80% during screening.
- Modified Medical Research Council (mMRC) Dyspnea Scale grade≥2 during screening.
- Background triple therapy (ICS+long-acting beta-agonists (LABA)+LAMA) for at least 3 months with a stable dose for at least 1 month prior to randomization; Double therapy allowed if ICS is contraindicated.
- With a history of acute exacerbation of ≥2 moderate or ≥1 severe within the previous 12 months prior to screening. Multiple acute exacerbation events with an interval of less than 14 days are counted as one.
You may not qualify if:
- COPD with asthma;
- Subjects with active pulmonary diseases other than COPD assessed by the investigator.
- Moderate to severe Acute exacerbations of chronic obstructive pulmonary disease (AECOPD) occurred within 4 weeks prior to screening or during screening;
- History of lung transplantation;
- Previous use of TQC2731.
- Diagnosis of alpha-1 anti-trypsin deficiency;
- History of lung volume reduction surgery or pneumonectomy within 6 months prior to randomization, or planned lung volume reduction surgery during the study period;
- Positive hepatitis B surface antigen, or hepatitis C virus antibody, or syphilis antibody.
- Diagnosis of immunodeficiency, including but not limited to HIV infection;
- Infection requiring systemic therapy within 2 weeks prior to randomization.
- Starting rehabilitation within 4 weeks prior to randomization, or planned rehabilitation during the study period;
- Treatment with oxygen of more than 12 hours per day.
- Heart failure New York Heart Association (NYHA) class III or IV during the screening period.
- History of malignancy within 5 years prior to screening, excluding cervical carcinoma in situ, ductal carcinoma in situ, etc.
- Pregnancy or breastfeeding.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (60)
The First People's Hospital of Chuzhou
Chuzhou, Anhui, 239001, China
The second hospital of ANHUI medical university
Hefei, Anhui, 230601, China
Huainan Dongfang Hospital Group General Hospital
Huainan, Anhui, 232033, China
Capital Medical University Beijing Chaoyang Hospital
Beijing, Beijing Municipality, 100020, China
China-Japan Friendship Hospital
Beijing, Beijing Municipality, 100029, China
The First Hospital of Lanzhou University
Lanzhou, Gansu, 730000, China
Shunde Hospital Of Southern Medical University
Foshan, Guangdong, 528308, China
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510120, China
Jiangmen Central Hospital
Jiangmen, Guangdong, 529000, China
Affiliated Qingyuan Hospital,Guangzhou Medical University,Qingyuan People's Hospital
Qingyuan, Guangdong, 511699, China
Zhongshan City People's Hospital
Zhongshan, Guangdong, 528403, China
Nanxishan Hospital of Guangxi Zhuang Autonomous
Guilin, Guangxi, 541002, China
The First People' Hospital Of YuLin
Yulin, Guangxi, 537000, China
Zunyi Medical University Affiliated Hospital
Zunyi, Guizhou, 563000, China
Cangzhou Central Hospital
Cangzhou, Hebei, 611011, China
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050000, China
Jiaozuo Second People's Hospital
Jiaozuo, Henan, 454150, China
The First Affiliated Hospital of Henan University of Science & Technology
Luoyang, Henan, 471003, China
Puyang Oilfield General Hospital
Puyang, Henan, 457001, China
Henan Chest Hospital
Zhengzhou, Henan, 450000, China
Jianghan University Affiliated Hospital (Wuhan Sixth Hospital)
Wuhan, Hubei, 430014, China
Wuhan Central Hospital
Wuhan, Hubei, 430014, China
Yichang Central People's Hospital
Yichang, Hubei, 443003, China
Changsha First Hospital
Changsha, Hunan, 410005, China
Xiangya Hospital of Central South University
Changsha, Hunan, 410008, China
The Third Xiangya Hospital of Central South University
Changsha, Hunan, 410013, China
Xiangtan County People's Hospital
Xiangtan, Hunan, 411228, China
Xiangya Hospital Zhuzhou Central South University
Zhuzhou, Hunan, 412007, China
Inner Mongolia Autonomous Region People's Hospital
Hohhot, Inner Mongolia, 010000, China
The Affiliated Hospital of Inner Mongolia Medical University
Hohhot, Inner Mongolia, 10000, China
Jiangyin Hospital of Traditional Chinese Medicine
Jiangyin, Jiangsu, 214400, China
The Fifth People's Hospital of Wuxi
Wuxi, Jiangsu, 214001, China
Yixing People'S Hospital
Wuxi, Jiangsu, 214200, China
XuZhou Central Hospital
Xuzhou, Jiangsu, 221000, China
Affiliated Hospital of Jiangsu University
Zhenjiang, Jiangsu, 212050, China
Jiangxi Provincial People's Hospital
Nanchang, Jiangxi, 330006, China
Xinyu People'S Hospital
Xinyu, Jiangxi, 338000, China
The First Hospital of Jilin University
Changchun, Jilin, 130021, China
General Hospital of Anshan Iron and Steel Group Corporation
Anshan, Liaoning, 114000, China
Benxi Central Hospital
Benxi, Liaoning, 117000, China
Shengjing Hospital of China Medical University
Shenyang, Liaoning, 110004, China
Heze Municipal Hospital
Heze, Shandong, 274000, China
Linyi People's Hospital
Linyi, Shandong, 276005, China
Qingdao Municipal Hospital
Qingdao, Shandong, 266011, China
Weifang NO.2 People' Hospital
Weifang, Shandong, 261041, China
Shanghai General Hospital
Shanghai, Shanghai Municipality, 200080, China
Shanghai JiaoTong University of medicine Ruijin Hospital
Shanghai, Shanghai Municipality, 20025, China
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, 200433, China
Affiliated Hospital Of ChengDu University
Chengdu, Sichuan, 610081, China
Guangyuan Central Hospital
Guangyuan, Sichuan, 628017, China
Leshan People's Hospital
Leshan, Sichuan, 614099, China
Meishan People's Hospital
Meishan, Sichuan, 620000, China
Suining Central Hospital
Suining, Sichuan, 629000, China
General Hospital of Tianjin Medical University
Tianjin, Tianjin Municipality, 300070, China
The Fourth Central Hospital of Tianjin
Tianjin, Tianjin Municipality, 300140, China
The First Affiliated Hospital of Shihezi University
Shihezi, Xinjiang, 832000, China
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, 831400, China
Jiaxing Second Hospital
Jiaxing, Zhejiang, 314000, China
Taizhou Central Hospital Central Hospital
Taizhou, Zhejiang, 318000, China
The 2th School of Medicine ,WMU/The 2th affiliated Hospital and Yuying Children's Hospital of WMU
Wenzhou, Zhejiang, 325027, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- 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
November 25, 2024
First Posted
November 27, 2024
Study Start
December 31, 2024
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
September 1, 2027
Last Updated
December 12, 2025
Record last verified: 2025-11