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New antibody injection aims to tame COPD Flare-Ups

NCT ID NCT06707883

Disease control Sponsor: Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This Phase 2 trial tests an injection called TQC2731 in 258 adults with moderate-to-severe COPD. The drug blocks a protein linked to airway inflammation. Researchers will measure how well it reduces the number of moderate or severe flare-ups over 24 weeks compared to a placebo.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
TQC2731 injection (a monoclonal antibody that blocks TSLP, a protein involved in airway inflammation)
What this could lead to
If successful, this could lead to a new treatment option that reduces the number of serious COPD flare-ups and improves lung function.
What could go wrong
This is an early Phase 2 trial with only 258 participants, so results may not apply to all COPD patients. The drug may not work better than placebo or could have side effects not yet seen.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

258 people

The number who actually took part.

Started

Dec 2024

Expected to finish

Sep 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

40 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

chronic obstructive pulmonary disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic obstructive pulmonary disease

Contacts and locations

Locations

  • Affiliated Hospital Of ChengDu University

    Chengdu, Sichuan, 610081, China

  • Affiliated Hospital of Jiangsu University

    Zhenjiang, Jiangsu, 212050, China

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

    Qingyuan, Guangdong, 511699, China

  • Benxi Central Hospital

    Benxi, Liaoning, 117000, China

  • Cangzhou Central Hospital

    Cangzhou, Hebei, 611011, China

  • Capital Medical University Beijing Chaoyang Hospital

    Beijing, Beijing Municipality, 100020, China

  • Changsha First Hospital

    Changsha, Hunan, 410005, China

  • China-Japan Friendship Hospital

    Beijing, Beijing Municipality, 100029, China

  • General Hospital of Anshan Iron and Steel Group Corporation

    Anshan, Liaoning, 114000, China

  • General Hospital of Tianjin Medical University

    Tianjin, Tianjin Municipality, 300070, China

  • Guangyuan Central Hospital

    Guangyuan, Sichuan, 628017, China

  • Henan Chest Hospital

    Zhengzhou, Henan, 450000, China

  • Heze Municipal Hospital

    Heze, Shandong, 274000, China

  • Huainan Dongfang Hospital Group General Hospital

    Huainan, Anhui, 232033, China

  • Inner Mongolia Autonomous Region People's Hospital

    Hohhot, Inner Mongolia, 010000, China

  • Jianghan University Affiliated Hospital (Wuhan Sixth Hospital)

    Wuhan, Hubei, 430014, China

  • Jiangmen Central Hospital

    Jiangmen, Guangdong, 529000, China

  • Jiangxi Provincial People's Hospital

    Nanchang, Jiangxi, 330006, China

  • Jiangyin Hospital of Traditional Chinese Medicine

    Jiangyin, Jiangsu, 214400, China

  • Jiaozuo Second People's Hospital

    Jiaozuo, Henan, 454150, China

  • Jiaxing Second Hospital

    Jiaxing, Zhejiang, 314000, China

  • Leshan People's Hospital

    Leshan, Sichuan, 614099, China

  • Linyi People's Hospital

    Linyi, Shandong, 276005, China

  • Meishan People's Hospital

    Meishan, Sichuan, 620000, China

  • Nanxishan Hospital of Guangxi Zhuang Autonomous

    Guilin, Guangxi, 541002, China

  • Puyang Oilfield General Hospital

    Puyang, Henan, 457001, China

  • Qingdao Municipal Hospital

    Qingdao, Shandong, 266011, 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

  • Shengjing Hospital of China Medical University

    Shenyang, Liaoning, 110004, China

  • Shunde Hospital Of Southern Medical University

    Foshan, Guangdong, 528308, China

  • Suining Central Hospital

    Suining, Sichuan, 629000, 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

  • The Affiliated Hospital of Inner Mongolia Medical University

    Hohhot, Inner Mongolia, 10000, China

  • The Fifth People's Hospital of Wuxi

    Wuxi, Jiangsu, 214001, China

  • The First Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong, 510120, China

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

    Luoyang, Henan, 471003, China

  • The First Affiliated Hospital of Shihezi University

    Shihezi, Xinjiang, 832000, China

  • The First Affiliated Hospital of Xinjiang Medical University

    Ürümqi, Xinjiang, 831400, China

  • The First Hospital of Jilin University

    Changchun, Jilin, 130021, China

  • The First Hospital of Lanzhou University

    Lanzhou, Gansu, 730000, China

  • The First People' Hospital Of YuLin

    Yulin, Guangxi, 537000, China

  • The First People's Hospital of Chuzhou

    Chuzhou, Anhui, 239001, China

  • The Fourth Central Hospital of Tianjin

    Tianjin, Tianjin Municipality, 300140, China

  • The Second Hospital of Hebei Medical University

    Shijiazhuang, Hebei, 050000, China

  • The Third Xiangya Hospital of Central South University

    Changsha, Hunan, 410013, China

  • The second hospital of ANHUI medical university

    Hefei, Anhui, 230601, China

  • Weifang NO.2 People' Hospital

    Weifang, Shandong, 261041, China

  • Wuhan Central Hospital

    Wuhan, Hubei, 430014, China

  • Xiangtan County People's Hospital

    Xiangtan, Hunan, 411228, China

  • Xiangya Hospital Zhuzhou Central South University

    Zhuzhou, Hunan, 412007, China

  • Xiangya Hospital of Central South University

    Changsha, Hunan, 410008, China

  • Xinyu People'S Hospital

    Xinyu, Jiangxi, 338000, China

  • XuZhou Central Hospital

    Xuzhou, Jiangsu, 221000, China

  • Yichang Central People's Hospital

    Yichang, Hubei, 443003, China

  • Yixing People'S Hospital

    Wuxi, Jiangsu, 214200, China

  • Zhongshan City People's Hospital

    Zhongshan, Guangdong, 528403, China

  • Zunyi Medical University Affiliated Hospital

    Zunyi, Guizhou, 563000, China

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Other studies related to the condition(s) this trial covers.