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

To evaluate the efficacy and safety of TQC2731 injection in patients with moderate to severe chronic obstructive pulmonary disease.

Study Overview

• Status: Active, not recruiting
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Drug: TQC2731 injection; Drug: TQC2731 Placebo

• Study Type: Interventional
• Enrollment (Actual): 258
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Anhui
    • Chuzhou, Anhui, China, 239001
      • The First People's Hospital of Chuzhou
    • Hefei, Anhui, China, 230601
      • The Second Hospital of Anhui Medical University
    • Huainan, Anhui, China, 232033
      • Huainan Dongfang Hospital Group General Hospital
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100029
      • China-Japan Friendship Hospital
    • Beijing, Beijing Municipality, China, 100020
      • Capital Medical University Beijing Chaoyang Hospital
  • Gansu
    • Lanzhou, Gansu, China, 730000
      • The First Hospital of Lanzhou University
  • Guangdong
    • Foshan, Guangdong, China, 528308
      • Shunde Hospital of Southern Medical University
    • Guangzhou, Guangdong, China, 510120
      • The First Affiliated Hospital of Guangzhou Medical University
    • Jiangmen, Guangdong, China, 529000
      • Jiangmen Central Hospital
    • Qingyuan, Guangdong, China, 511699
      • Affiliated Qingyuan Hospital,Guangzhou Medical University,Qingyuan People's Hospital
    • Zhongshan, Guangdong, China, 528403
      • Zhongshan City People's Hospital
  • Guangxi
    • Guilin, Guangxi, China, 541002
      • Nanxishan Hospital of Guangxi Zhuang Autonomous
    • Yulin, Guangxi, China, 537000
      • The First People' Hospital Of YuLin
  • Guizhou
    • Zunyi, Guizhou, China, 563000
      • Zunyi Medical University Affiliated Hospital
  • Hebei
    • Cangzhou, Hebei, China, 611011
      • Cangzhou Central Hospital
    • Shijiazhuang, Hebei, China, 050000
      • The Second Hospital of Hebei Medical University
  • Henan
    • Jiaozuo, Henan, China, 454150
      • Jiaozuo Second People's Hospital
    • Luoyang, Henan, China, 471003
      • The First Affiliated Hospital of Henan University of Science & Technology
    • Puyang, Henan, China, 457001
      • Puyang Oilfield General Hospital
    • Zhengzhou, Henan, China, 450000
      • Henan Chest Hospital
  • Hubei
    • Wuhan, Hubei, China, 430014
      • Wuhan Central Hospital
    • Wuhan, Hubei, China, 430014
      • Jianghan University Affiliated Hospital (Wuhan Sixth Hospital)
    • Yichang, Hubei, China, 443003
      • Yichang Central People's Hospital
  • Hunan
    • Changsha, Hunan, China, 410008
      • Xiangya Hospital of Central South University
    • Changsha, Hunan, China, 410013
      • The third xiangya hospital of Central South University
    • Changsha, Hunan, China, 410005
      • Changsha First Hospital
    • Xiangtan, Hunan, China, 411228
      • Xiangtan County People's Hospital
    • Zhuzhou, Hunan, China, 412007
      • Xiangya Hospital ZhuZhou Central South University
  • Inner Mongolia
    • Hohhot, Inner Mongolia, China, 10000
      • The Affiliated Hospital of Inner Mongolia Medical University
    • Hohhot, Inner Mongolia, China, 010000
      • Inner Mongolia Autonomous Region People's Hospital
  • Jiangsu
    • Jiangyin, Jiangsu, China, 214400
      • Jiangyin Hospital of Traditional Chinese Medicine
    • Wuxi, Jiangsu, China, 214200
      • Yixing People'S Hospital
    • Wuxi, Jiangsu, China, 214001
      • The Fifth People's Hospital of Wuxi
    • Xuzhou, Jiangsu, China, 221000
      • Xuzhou Central Hospital
    • Zhenjiang, Jiangsu, China, 212050
      • Affiliated Hospital of Jiangsu University
  • Jiangxi
    • Nanchang, Jiangxi, China, 330006
      • Jiangxi Provincial People's Hospital
    • Xinyu, Jiangxi, China, 338000
      • Xinyu People'S Hospital
  • Jilin
    • Changchun, Jilin, China, 130021
      • The First Hospital of Jilin University
  • Liaoning
    • Anshan, Liaoning, China, 114000
      • General Hospital of Anshan Iron and Steel Group Corporation
    • Benxi, Liaoning, China, 117000
      • Benxi Central Hospital
    • Shenyang, Liaoning, China, 110004
      • Shengjing Hospital of China Medical University
  • Shandong
    • Heze, Shandong, China, 274000
      • Heze Municipal Hospital
    • Linyi, Shandong, China, 276005
      • Linyi people's hospital
    • Qingdao, Shandong, China, 266011
      • Qingdao Municipal Hospital
    • Weifang, Shandong, China, 261041
      • Weifang NO.2 People' Hospital
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200080
      • Shanghai General Hospital
    • Shanghai, Shanghai Municipality, China, 200433
      • Shanghai Pulmonary Hospital
    • Shanghai, Shanghai Municipality, China, 20025
      • Shanghai JiaoTong University of medicine Ruijin Hospital
  • Sichuan
    • Chengdu, Sichuan, China, 610081
      • Affiliated Hospital Of ChengDu University
    • Guangyuan, Sichuan, China, 628017
      • Guangyuan Central Hospital
    • Leshan, Sichuan, China, 614099
      • Leshan People's Hospital
    • Meishan, Sichuan, China, 620000
      • Meishan People's Hospital
    • Suining, Sichuan, China, 629000
      • Suining Central Hospital
  • Tianjin Municipality
    • Tianjin, Tianjin Municipality, China, 300140
      • The Fourth Central Hospital of Tianjin
    • Tianjin, Tianjin Municipality, China, 300070
      • General Hospital of Tianjin Medical University
  • Xinjiang
    • Shihezi, Xinjiang, China, 832000
      • The First Affiliated Hospital of Shihezi University
    • Ürümqi, Xinjiang, China, 831400
      • The First Affiliated Hospital of Xinjiang Medical University
  • Zhejiang
    • Jiaxing, Zhejiang, China, 314000
      • Jiaxing Second Hospital
    • Taizhou, Zhejiang, China, 318000
      • Taizhou Central Hospital Central Hospital
    • Wenzhou, Zhejiang, China, 325027
      • The 2th School of Medicine ,WMU/The 2th affiliated Hospital and Yuying Children's Hospital of WMU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TQC2731 injection; TQC2731 injection, 28days as a treatment cycle.	Drug: TQC2731 injection; TQC2731 injection is a monoclonal antibody that blocks thymic stromal lymphopoietin (TSLP)
Placebo Comparator: TQC2731 Placebo; TQC2731 Placebo, 28days as a treatment cycle.	Drug: TQC2731 Placebo; TQC2731 Placebo without drug substance.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in SGRQ	Change from baseline to Week 52 in SGRQ total score compared to placebo	Baseline to week 52
Change in pre-bronchodilator forced expiratory volume (FEV1)	Change in pre-bronchodilator FEV1 from baseline to week 24 compared to placebo.	Baseline to week 24
Annual rate of acute COPD exacerbation	Annualized rate of moderate COPD exacerbations over the 52-week treatment period compared to placebo.	Baseline to week 52
Improvement in St. George's Respiratory Questionnaire (SGRQ)	Proportion of patients with SGRQ improvement ≥4 points at Week 52	Baseline to week 52
Change in pre-bronchodilator FEV1	Change in pre-bronchodilator FEV1 from baseline to week 52 compared to placebo.	Baseline to week 52
Annual rate of acute COPD exacerbation	Annualized rate of severe COPD exacerbations over the 52-week treatment period compared to placebo.	Baseline to week 52
Change in post-bronchodilator FEV1	Change in post-bronchodilator FEV1 from baseline to week 24 and 52 compared to placebo.	Baseline to week 24 and 52
Change in EXACT	Change from baseline to Week 52 in EXACT total score compared to placebo.	Baseline to week 52
Adverse Events (AE) and Serious Adverse Events (SAE)	The incidence and severity of AE and SAE, as well as abnormal laboratory examination index.	Baseline to 64 weeks
Anti-drug antibodies (ADA)	Incidence of ADA.	Baseline through week 52
Immunoglobulin E (IgE)	Changes in IgE levels in peripheral blood.	Baseline to 52 weeks
Fractional exhaled nitric oxide (FeNO)	Changes in FeNO.	Baseline to 52 weeks

Collaborators and Investigators

• Sponsor: Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): December 31, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: November 25, 2024
• First Submitted That Met QC Criteria: November 26, 2024
• First Posted (Actual): November 27, 2024

Study Record Updates

• Last Update Posted (Actual): December 12, 2025
• Last Update Submitted That Met QC Criteria: December 10, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pathological Conditions, Signs and Symptoms; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: TQC2731-II-04

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No