New antibody drug aims to cut COPD attacks in half

NCT ID NCT06789289

Disease control Sponsor: Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. Source: ClinicalTrials.gov ↗

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

Summary

This phase 2 trial tests TQC2938, a lab-made antibody, in 256 people with moderate to severe COPD. The goal is to see if the drug can reduce the number of serious flare-ups over 24 weeks compared to a placebo. Participants receive injections and are monitored for safety and side effects.

What this could mean

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

Active substance: TQC2938 (a lab-made antibody that blocks certain signals in the body)
What this could lead to: If it works, this could lead to a new treatment that reduces the number of serious COPD flare-ups, helping patients breathe easier and stay out of the hospital.
What could go wrong: This is a mid-stage trial with only 256 people, so results may not apply to everyone. The drug is still experimental, and side effects or lack of benefit are possible.

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

256 people

The number who actually took part.

Started

Mar 2025

Expected to finish

Dec 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: * Understand and sign the written informed consent, and comply with the research process schedule during the study period.； * Be aged 40-80 years inclusive at the time of signing the informed consent form； * Have a record of COPD diagnosis for at least 12 months prior to screening； * At screening or after bronchodilator use at the time of the first dose, FEV1 is ≥20% but \<80% of the predicted value； * The FEV1/forced vital capacity (FVC) ratio, measured after the use of bronchodilators at screening or at the time of the first dose, is less than 0.70； * At screening, the Modified Medical Research Council (mMRC) score is ≥2； * At screening, the CAT≥10； * Current smokers or former smokers (who have quit smoking for at least 6 months before Visit 1) with a smoking history of ≥10 pack-years (for example: 20 cigarettes/day for 10 years). At screening, subjects who meet the definition of current smokers will be referred to a smoking cessation clinic； * A chest X-ray or computed tomography (CT) scan within the 3 months prior to screening or during the screening period (before the first dose of study medication) confirms that there are no other clinically significant pulmonary diseases present apart from COPD. Exclusion Criteria: * History of severe allergic reactions or anaphylaxis to biologic agents, or known hypersensitivity to any component of the study drug, or a history of medications or other allergens that the investigator believes would prevent the subject from participating in the study; * Current or past confirmed diagnosis of asthma; * History of other clinically significant pulmonary diseases apart from COPD: such as lung cancer, bronchiectasis, sarcoidosis, pulmonary fibrosis, interstitial lung diseases, cystic fibrosis, constrictive bronchiolitis, tuberculosis, or other active pulmonary diseases; * Evidence of cor pulmonale with right heart failure； * Diagnosed with α-1-antitrypsin deficiency; * History of long-term oxygen therapy with \>4 L/min; * When using respiratory assistive oxygen, the subject's oxygen saturation should be \< 89%; * Undergone lung volume reduction surgery or procedures within the 12 months prior to screening; * Subjects participating or planning to participate in an intensive COPD rehabilitation program (subjects in the maintenance phase of a rehabilitation program are eligible for this study); * History of lung transplantation; * Any infection requiring hospitalization for ≥24 hours and/or treatment with oral, IV, or IM antibiotics within 4 weeks prior to screening or during the screening period; * Upper or lower respiratory tract infections requiring antibiotic or antiviral medication within 4 weeks prior to screening or during the screening period; * Moderate to severe COPD exacerbations within 4 weeks prior to screening or during the screening period. * Received treatment with oral, IV, or intramuscular (IM) corticosteroids (\>10 mg/day prednisone or equivalent dose) within 4 weeks prior to starting study medication; * Received treatment with clinical trial medication, approved biologics (e.g., omalizumab, dupilumab, and/or anti-Interleukin 5 (IL-5) therapies) within 3 months prior to screening or within 5 half-lives of the drug (whichever is longer), or started or changed non-biologic immunomodulatory or immunosuppressive therapies; * Receiving palliative care due to chronic respiratory disease, cardiovascular disease, endocrine and other systemic diseases, or cancer (e.g., for subjects with a life expectancy \<12 months); * Undergone major surgery within 8 weeks prior to screening or planning to undergo surgery that requires general anesthesia or hospitalization \>1 day during the study period; * Received or planning to receive live attenuated vaccine within 4 weeks prior to screening, during the screening period, or during the study period; * Known immune deficiency, including but not limited to HIV infection; * Elevated Aspartate Aminotransferase (AST), Alanine transaminase (ALT), or total bilirubin ≥2.0× the upper limit of normal (ULN) during the screening period; * At screening, presence of any of the following: positive for hepatitis B surface antigen (HBsAg), positive for both hepatitis C virus antibody (HCV Ab) and hepatitis C virus RNA (HCV-RNA), positive for both specific and non-specific antibodies for syphilis (TP Ab); * As determined by the investigator, history of illicit drug or drug abuse within the 12 months prior to screening; * History of malignancy within 5 years prior to screening, except for those with negligible risk of metastasis or death (e.g., with a 5-year overall survival rate \>90%), such as adequately treated carcinoma in situ of the cervix, non-melanoma skin cancer, localized prostate cancer, or ductal carcinoma in situ; * Presence of any other serious disease or abnormal clinical laboratory test results that, in the opinion of the investigator, would prevent the subject from safely participating in or completing the study； * Unstable cardiac disease, myocardial infarction, or New York Heart Association Class III or IV heart failure within 12 months prior to screening; * History or current presence of clinically significant ECG abnormalities, as determined by the investigator, including but not limited to: (1) Atrial fibrillation (AF) with a rapid ventricular rate \>120 bpm; (2) Sustained ventricular tachycardia (VT); (3) Bradycardia with a ventricular rate \<45 bpm; (4) Mobitz Type II second-degree atrioventricular block and third-degree atrioventricular block (unless a pacemaker or defibrillator has been implanted); * Corrected QT interval (QTcF) \>450 ms for male subjects or \>470 ms for female subjects; for subjects with Q wave, R wave, and S wave (QRS) \>120 ms, QTcF \>480 ms； * History of ventricular arrhythmias or risk factors for ventricular arrhythmias, such as structural heart disease (e.g., severe left ventricular systolic dysfunction, severe left ventricular hypertrophy with fibrosis), family history of unexplained sudden death or long QT syndrome, or history of sinus bradycardia (ventricular rate \<45 beats/min); * Pregnant or breastfeeding, or planning to become pregnant during the study period or within 12 weeks after the last dose of TQC2938, or female subjects with a positive pregnancy test at screening or randomization.

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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
An Hui Chest Hospital

Hefei, Anhui, 230000, China
Cangzhou Central Hospital

Cangzhou, Hebei, 061000, China
China-Japan Friendship Hospital

Beijing, Beijing Municipality, 100029, China
Henan Chest Hospital

Zhengzhou, Henan, 450000, China
Heze Municipal Hospital

Heze, Shandong, China
Jiangmen Central Hospital

Jiangmen, Guangdong, 529000, China
Jiangxi Provincal People's Hospital

Nanchang, Jiangxi, 330000, China
Jinhua Municipal Centeral Hospital Medical Group

Jinhua, Zhejiang, 321000, China
Leshan People's Hospital

Leshan, Sichuan, 614099, China
Linfen Central Hospital

Linfen, Shanxi, 041099, China
Liuzhou municipal liutie central hospital

Liuzhou, Guangxi, 545007, China
Meihekou Central Hospital

Meihekou, Jilin, 135000, China
Peking University First Hospital

Beijing, Beijing Municipality, 100034, China
Peolpe's Hospital Of Chongqing Banan District

Chongqing, Chongqing Municipality, 400054, China
Puyang Oilfield General Hospital

Puyang, Henan, 457001, China
Shanghai JiaoTong University of medicine Ruijin Hospital

Shanghai, Shanghai Municipality, 20025, China
Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, 200433, China
Shaoyang Central Hospital

Shaoyang, Hunan, 422000, China
Shunde Hospital Of Southern Medical University

Foshan, Guangdong, 528308, China
Siping Central People's Hospital

Siping, Jilin, 136099, China
Suining Central Hospital

Suining, Sichuan, 629000, China
Taizhou Hospital Of Zhejiang Province

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 Mongolia Medical College

Hohhot, Inner Mongolia, 010000, China
The First Affiliated Hospital of Jiamusi University

Jiamusi, Heilongjiang, 154003, China
The First Affiliated Hospitial Of Ningbo University

Ningbo, Zhejiang, 315211, China
The First Hospital of Qiqihar

Qiqihar, Heilongjiang, 161005, China
The First People' Hospital Of YuLin

Yulin, Guangxi, 537000, China
The First People's Hospital of Xinxiang City

Xinxiang, Henan, 453000, China
The Fourth Central Hospital of Tianjin

Tianjin, Tianjin Municipality, 300140, China
The Third People's Hospital of Xinjiang Uygur Autonomous Region

Ürümqi, Xinjiang, 830091, China
The second hospital of hebei medical university

Shijiazhuang, Heibei, 05000, China
The second xiangya hospital of central south university

Changsha, Hunan, 410011, China
Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, 300041, China
Weifang NO.2 People' Hospital

Weifang, Shandong, 261041, China
Xi'An International Medicl Center Hospital

Xi’an, Shanxi, 710061, China
Xingtai People's Hospital

Xingtai, Hebei, 54000, China
Yongcheng People's Hospital

Yongcheng, Henan, 476600, China

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