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Chronic Obstructive Pulmonary DiseasePhase 2NCT06707883

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

A Phase 2 study testing TQC2731 injection in people with Chronic Obstructive Pulmonary Disease, run by Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd. at 60 sites in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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

Who is it for?
Ages 40 to 80 years
Conditions the study is for
Chronic Obstructive Pulmonary Disease
What is being tested?
TQC2731 injection
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
258 participants
Where
60 sitesChina
Study dates
31 Dec 2024to Sep 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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;
Show all 15Show fewer
  • 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.

Trial locations and contacts

60 sites in 1 country.

60 sites in 1 country

China60 sites

  • General Hospital of Anshan Iron and Steel Group Corporation

    Anshan, Liaoning, 114000

  • Capital Medical University Beijing Chaoyang Hospital

    Beijing, Beijing Municipality, 100020

  • China-Japan Friendship Hospital

    Beijing, Beijing Municipality, 100029

  • Benxi Central Hospital

    Benxi, Liaoning, 117000

  • Cangzhou Central Hospital

    Cangzhou, Hebei, 611011

  • The First Hospital of Jilin University

    Changchun, Jilin, 130021

  • Changsha First Hospital

    Changsha, Hunan, 410005

  • Xiangya Hospital of Central South University

    Changsha, Hunan, 410008

  • The Third Xiangya Hospital of Central South University

    Changsha, Hunan, 410013

  • Affiliated Hospital Of ChengDu University

    Chengdu, Sichuan, 610081

  • The First People's Hospital of Chuzhou

    Chuzhou, Anhui, 239001

  • Shunde Hospital Of Southern Medical University

    Foshan, Guangdong, 528308

  • Guangyuan Central Hospital

    Guangyuan, Sichuan, 628017

  • The First Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong, 510120

  • Nanxishan Hospital of Guangxi Zhuang Autonomous

    Guilin, Guangxi, 541002

  • The second hospital of ANHUI medical university

    Hefei, Anhui, 230601

  • Heze Municipal Hospital

    Heze, Shandong, 274000

  • Inner Mongolia Autonomous Region People's Hospital

    Hohhot, Inner Mongolia, 010000

  • The Affiliated Hospital of Inner Mongolia Medical University

    Hohhot, Inner Mongolia, 10000

  • Huainan Dongfang Hospital Group General Hospital

    Huainan, Anhui, 232033

  • Jiangmen Central Hospital

    Jiangmen, Guangdong, 529000

  • Jiangyin Hospital of Traditional Chinese Medicine

    Jiangyin, Jiangsu, 214400

  • Jiaozuo Second People's Hospital

    Jiaozuo, Henan, 454150

  • Jiaxing Second Hospital

    Jiaxing, Zhejiang, 314000

  • The First Hospital of Lanzhou University

    Lanzhou, Gansu, 730000

  • Leshan People's Hospital

    Leshan, Sichuan, 614099

  • Linyi People's Hospital

    Linyi, Shandong, 276005

  • The First Affiliated Hospital of Henan University of Science & Technology

    Luoyang, Henan, 471003

  • Meishan People's Hospital

    Meishan, Sichuan, 620000

  • Jiangxi Provincial People's Hospital

    Nanchang, Jiangxi, 330006

  • Puyang Oilfield General Hospital

    Puyang, Henan, 457001

  • Qingdao Municipal Hospital

    Qingdao, Shandong, 266011

  • Affiliated Qingyuan Hospital,Guangzhou Medical University,Qingyuan People's Hospital

    Qingyuan, Guangdong, 511699

  • Shanghai General Hospital

    Shanghai, Shanghai Municipality, 200080

  • Shanghai JiaoTong University of medicine Ruijin Hospital

    Shanghai, Shanghai Municipality, 20025

  • Shanghai Pulmonary Hospital

    Shanghai, Shanghai Municipality, 200433

  • Shengjing Hospital of China Medical University

    Shenyang, Liaoning, 110004

  • The First Affiliated Hospital of Shihezi University

    Shihezi, Xinjiang, 832000

  • The Second Hospital of Hebei Medical University

    Shijiazhuang, Hebei, 050000

  • Suining Central Hospital

    Suining, Sichuan, 629000

  • Taizhou Central Hospital Central Hospital

    Taizhou, Zhejiang, 318000

  • General Hospital of Tianjin Medical University

    Tianjin, Tianjin Municipality, 300070

  • The Fourth Central Hospital of Tianjin

    Tianjin, Tianjin Municipality, 300140

  • The First Affiliated Hospital of Xinjiang Medical University

    Ürümqi, Xinjiang, 831400

  • Weifang NO.2 People' Hospital

    Weifang, Shandong, 261041

  • The 2th School of Medicine ,WMU/The 2th affiliated Hospital and Yuying Children's Hospital of WMU

    Wenzhou, Zhejiang, 325027

  • Jianghan University Affiliated Hospital (Wuhan Sixth Hospital)

    Wuhan, Hubei, 430014

  • Wuhan Central Hospital

    Wuhan, Hubei, 430014

  • The Fifth People's Hospital of Wuxi

    Wuxi, Jiangsu, 214001

  • Yixing People'S Hospital

    Wuxi, Jiangsu, 214200

  • Xiangtan County People's Hospital

    Xiangtan, Hunan, 411228

  • Xinyu People'S Hospital

    Xinyu, Jiangxi, 338000

  • XuZhou Central Hospital

    Xuzhou, Jiangsu, 221000

  • Yichang Central People's Hospital

    Yichang, Hubei, 443003

  • The First People' Hospital Of YuLin

    Yulin, Guangxi, 537000

  • Henan Chest Hospital

    Zhengzhou, Henan, 450000

  • Affiliated Hospital of Jiangsu University

    Zhenjiang, Jiangsu, 212050

  • Zhongshan City People's Hospital

    Zhongshan, Guangdong, 528403

  • Xiangya Hospital Zhuzhou Central South University

    Zhuzhou, Hunan, 412007

  • Zunyi Medical University Affiliated Hospital

    Zunyi, Guizhou, 563000

Other trials in China

About this study

Official title: 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.

Being tested
TQC2731 injection, TQC2731 Placebo
Medical subject headings
Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TQC2731 injectionDrug

    TQC2731 injection is a monoclonal antibody that blocks thymic stromal lymphopoietin (TSLP)

  • TQC2731 PlaceboDrug

    TQC2731 Placebo without drug substance.

Study groups in NCT06707883
Study groupRoleWhat they receive
TQC2731 injectionExperimentalTQC2731 injection, 28days as a treatment cycle.
Receives: Drug: TQC2731 injection
TQC2731 PlaceboPlacebo comparatorTQC2731 Placebo, 28days as a treatment cycle.
Receives: Drug: TQC2731 Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Annual rate of acute COPD exacerbation

    Annualized rate of moderate or severe COPD exacerbations over the 24-week treatment period compared to placebo

    Measured: Baseline to week 24

Secondary outcomes (12)

  1. Change in pre-bronchodilator forced expiratory volume (FEV1)

    Change in pre-bronchodilator FEV1 from baseline to week 24 compared to placebo.

    Measured: Baseline to week 24

  2. Annual rate of acute COPD exacerbation

    Annualized rate of moderate COPD exacerbations over the 52-week treatment period compared to placebo.

    Measured: Baseline to week 52

  3. Improvement in St. George's Respiratory Questionnaire (SGRQ)

    Proportion of patients with SGRQ improvement ≥4 points at Week 52

    Measured: Baseline to week 52

  4. Change in SGRQ

    Change from baseline to Week 52 in SGRQ total score compared to placebo

    Measured: Baseline to week 52

  5. Change in pre-bronchodilator FEV1

    Change in pre-bronchodilator FEV1 from baseline to week 52 compared to placebo.

    Measured: Baseline to week 52

  6. Annual rate of acute COPD exacerbation

    Annualized rate of severe COPD exacerbations over the 52-week treatment period compared to placebo.

    Measured: Baseline to week 52

  7. Change in post-bronchodilator FEV1

    Change in post-bronchodilator FEV1 from baseline to week 24 and 52 compared to placebo.

    Measured: Baseline to week 24 and 52

  8. Change in EXACT

    Change from baseline to Week 52 in EXACT total score compared to placebo.

    Measured: Baseline to week 52

  9. Adverse Events (AE) and Serious Adverse Events (SAE)

    The incidence and severity of AE and SAE, as well as abnormal laboratory examination index.

    Measured: Baseline to 64 weeks

  10. Anti-drug antibodies (ADA)

    Incidence of ADA.

    Measured: Baseline through week 52

  11. Immunoglobulin E (IgE)

    Changes in IgE levels in peripheral blood.

    Measured: Baseline to 52 weeks

  12. Fractional exhaled nitric oxide (FeNO)

    Changes in FeNO.

    Measured: Baseline to 52 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Nov 2024
  2. Study start31 Dec 2024
  3. Primary completionDec 2026 (estimated)
  4. Study completionSep 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
258 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06707883
Sponsor's protocol ID
TQC2731-II-04
Status last verified
Nov 2025
First submitted
25 Nov 2024
Last updated
12 Dec 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing TQC2731 injection in people with Chronic Obstructive Pulmonary Disease, run by Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd. at 60 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 12 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 60 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Annual rate of acute COPD exacerbation (time frame: Baseline to week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06707883.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2025.

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