A Clinical Study of TQC2731 Injection in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease

December 10, 2025 updated by: Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd.

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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
258

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Annual rate of acute COPD exacerbation
Time Frame: Baseline to week 24
Annualized rate of moderate or severe COPD exacerbations over the 24-week treatment period compared to placebo
Baseline to week 24

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in SGRQ
Time Frame: Baseline to week 52
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)
Time Frame: Baseline to week 24
Change in pre-bronchodilator FEV1 from baseline to week 24 compared to placebo.
Baseline to week 24
Annual rate of acute COPD exacerbation
Time Frame: Baseline to week 52
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)
Time Frame: Baseline to week 52
Proportion of patients with SGRQ improvement ≥4 points at Week 52
Baseline to week 52
Change in pre-bronchodilator FEV1
Time Frame: Baseline to week 52
Change in pre-bronchodilator FEV1 from baseline to week 52 compared to placebo.
Baseline to week 52
Annual rate of acute COPD exacerbation
Time Frame: Baseline to week 52
Annualized rate of severe COPD exacerbations over the 52-week treatment period compared to placebo.
Baseline to week 52
Change in post-bronchodilator FEV1
Time Frame: Baseline to week 24 and 52
Change in post-bronchodilator FEV1 from baseline to week 24 and 52 compared to placebo.
Baseline to week 24 and 52
Change in EXACT
Time Frame: Baseline to week 52
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)
Time Frame: Baseline to 64 weeks
The incidence and severity of AE and SAE, as well as abnormal laboratory examination index.
Baseline to 64 weeks
Anti-drug antibodies (ADA)
Time Frame: Baseline through week 52
Incidence of ADA.
Baseline through week 52
Immunoglobulin E (IgE)
Time Frame: Baseline to 52 weeks
Changes in IgE levels in peripheral blood.
Baseline to 52 weeks
Fractional exhaled nitric oxide (FeNO)
Time Frame: Baseline to 52 weeks
Changes in FeNO.
Baseline to 52 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 31, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 25, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 26, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 27, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 12, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 10, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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