Chronic Obstructive Pulmonary DiseasePhase 2NCT06789289
A Clinical Study to Evaluate the Efficacy and Safety of TQC2938 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease
A Phase 2 study testing TQC2938 injection in people with Chronic Obstructive Pulmonary Disease, run by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. at 40 sites in China.
Trial summary
The study is a Phase II, multicenter, double-blind, randomized, parallel, placebo-controlled clinical trial designed to evaluate the efficacy, safety, tolerability, and pharmacokinetic characteristics of TQC2938 in patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD). 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?
- TQC2938 injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 256 participants
- Where
- 40 sitesChina
- Study dates
- 17 Mar 2025to Dec 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
- 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；
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- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
40 sites in 1 country.
40 sites in 1 country
China40 sites
China-Japan Friendship Hospital
Beijing, Beijing Municipality, 100029
Peking University First Hospital
Beijing, Beijing Municipality, 100034
Cangzhou Central Hospital
Cangzhou, Hebei, 061000
The second xiangya hospital of central south university
Changsha, Hunan, 410011
Affiliated Hospital Of ChengDu University
Chengdu, Sichuan, 610081
Peolpe's Hospital Of Chongqing Banan District
Chongqing, Chongqing Municipality, 400054
Shunde Hospital Of Southern Medical University
Foshan, Guangdong, 528308
An Hui Chest Hospital
Hefei, Anhui, 230000
Heze Municipal Hospital
Heze, Shandong
The Affiliated Hospital of Mongolia Medical College
Hohhot, Inner Mongolia, 010000
The First Affiliated Hospital of Jiamusi University
Jiamusi, Heilongjiang, 154003
Jiangmen Central Hospital
Jiangmen, Guangdong, 529000
Jinhua Municipal Centeral Hospital Medical Group
Jinhua, Zhejiang, 321000
Leshan People's Hospital
Leshan, Sichuan, 614099
Linfen Central Hospital
Linfen, Shanxi, 041099
Liuzhou municipal liutie central hospital
Liuzhou, Guangxi, 545007
Meihekou Central Hospital
Meihekou, Jilin, 135000
Jiangxi Provincal People's Hospital
Nanchang, Jiangxi, 330000
The First Affiliated Hospitial Of Ningbo University
Ningbo, Zhejiang, 315211
Puyang Oilfield General Hospital
Puyang, Henan, 457001
The First Hospital of Qiqihar
Qiqihar, Heilongjiang, 161005
Shanghai JiaoTong University of medicine Ruijin Hospital
Shanghai, Shanghai Municipality, 20025
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, 200433
Shaoyang Central Hospital
Shaoyang, Hunan, 422000
The second hospital of hebei medical university
Shijiazhuang, Heibei, 05000
Siping Central People's Hospital
Siping, Jilin, 136099
Suining Central Hospital
Suining, Sichuan, 629000
Taizhou Hospital Of Zhejiang Province
Taizhou, Zhejiang, 318000
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, 300041
The Fourth Central Hospital of Tianjin
Tianjin, Tianjin Municipality, 300140
The Third People's Hospital of Xinjiang Uygur Autonomous Region
Ürümqi, Xinjiang, 830091
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
Xi'An International Medicl Center Hospital
Xi’an, Shanxi, 710061
Xingtai People's Hospital
Xingtai, Hebei, 54000
The First People's Hospital of Xinxiang City
Xinxiang, Henan, 453000
Yongcheng People's Hospital
Yongcheng, Henan, 476600
The First People' Hospital Of YuLin
Yulin, Guangxi, 537000
Henan Chest Hospital
Zhengzhou, Henan, 450000
Affiliated Hospital of Jiangsu University
Zhenjiang, Jiangsu, 212050
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Phase II Clinical Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetic Characteristics of TQC2938 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease
The study is a Phase II, multicenter, double-blind, randomized, parallel, placebo-controlled clinical trial designed to evaluate the efficacy, safety, tolerability, and pharmacokinetic characteristics of TQC2938 in patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD). It is anticipated that 256 subjects will be enrolled.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- TQC2938 injection, TQC2938 injection 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.
TQC2938 injectionDrug
TQC2938 is a humanized monoclonal antibody that interfering with the signal cascade.
TQC2938 injection PlaceboDrug
TQC2938 is a humanized monoclonal antibody that interfering with the signal cascade.
| Study group | Role | What they receive |
|---|---|---|
| TQC2938 injection | Experimental | TQC2938 injection is injected subcutaneously every 28 days for a treatment cycle of 52 weeks. Receives: Drug: TQC2938 injection |
| TQC2938 injection Placebo | Placebo comparator | Subcutaneous injection of 0 mg TQC2938 injection solution, with a treatment cycle of every 28 days, for a total of 52 weeks. Receives: Drug: TQC2938 injection Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The annualized incidence rate of moderate to severe acute exacerbations of chronic obstructive pulmonary disease (AECOPD within 24 weeks
Within a 24-week period, the number of acute exacerbations of chronic obstructive pulmonary disease (AECOPD) is converted to an annual incidence rate.
Measured: Baseline up to week 24
Secondary outcomes (6)
Safety and tolerability assessment
The incidence and severity of adverse events, adverse reactions, serious adverse events, as well as abnormal clinical laboratory test indicators, vital signs, physical examinations, and 12-lead electrocardiograms.
Measured: Baseline up to week 64
Within a 52-week period, the number of acute exacerbations of chronic obstructive pulmonary disease (AECOPD) is converted to an annual incidence rate
Within a 52-week period, the number of acute exacerbations of chronic obstructive pulmonary disease (AECOPD) is converted to an annual incidence rate.
Measured: Baseline up to week 52
The change in trough volume of forceful exhalation in the first second (FEV1) (pre-bronchodilator) from baseline after 24 weeks
Comparing the difference between the highest FEV1 values at 24 weeks and at baseline for the subjects.
Measured: Baseline up to week 24
The change in trough FEV1 (pre-bronchodilator) from baseline after 52weeks
Comparing the difference between the lowest FEV1 values at 52 weeks and the lowest FEV1 values at baseline for the subjects.
Measured: Baseline up to week 52
The change in FEV1 from baseline after 52 weeks of bronchodilator use
The change in FEV1 from baseline after 52 weeks of bronchodilator use
Measured: Baseline up to week 52
The annualized incidence rate of severe AECOPD within 52 weeks
Within a 52-week period, the number of severe acute exacerbations of chronic obstructive pulmonary disease (AECOPD) is converted to an annual incidence rate.
Measured: Baseline up to week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2025
- Study start17 Mar 2025
- Primary completion17 Mar 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 256 participants (actual)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06789289
- Sponsor's protocol ID
- TQC2938-II-01
- Status last verified
- Nov 2025
- First submitted
- 17 Jan 2025
- Last updated
- 7 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Phase II Clinical Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetic Characteristics of TQC2938 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT06789289
- Acronym / sponsor ID
- TQC2938-II-01
- Conditions
- Chronic Obstructive Pulmonary Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 256 participants (actual)
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 17 Mar 2025 (actual)
- Primary completion
- 17 Mar 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 23 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is a Phase II, multicenter, double-blind, randomized, parallel, placebo-controlled clinical trial designed to evaluate the efficacy, safety, tolerability, and pharmacokinetic characteristics of TQC2938 in patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD). It is anticipated that 256 subjects will be enrolled.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TQC2938 injection | Experimental | Drug: TQC2938 injectionTQC2938 injection is injected subcutaneously every 28 days for a treatment cycle of 52 weeks. |
| TQC2938 injection Placebo | Placebo comparator | Drug: TQC2938 injection PlaceboSubcutaneous injection of 0 mg TQC2938 injection solution, with a treatment cycle of every 28 days, for a total of 52 weeks. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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；
Key exclusion criteria (29 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TQC2938 injectionTQC2938 is a humanized monoclonal antibody that interfering with the signal cascade. | Drug | TQC2938 injection |
| TQC2938 injection PlaceboTQC2938 is a humanized monoclonal antibody that interfering with the signal cascade. | Drug | TQC2938 injection Placebo |
Primary outcome
The annualized incidence rate of moderate to severe acute exacerbations of chronic obstructive pulmonary disease (AECOPD within 24 weeks
Time frame: Baseline up to week 24
Within a 24-week period, the number of acute exacerbations of chronic obstructive pulmonary disease (AECOPD) is converted to an annual incidence rate.
6 secondary outcomes
Safety and tolerability assessment
Time frame: Baseline up to week 64
Within a 52-week period, the number of acute exacerbations of chronic obstructive pulmonary disease (AECOPD) is converted to an annual incidence rate
Time frame: Baseline up to week 52
The change in trough volume of forceful exhalation in the first second (FEV1) (pre-bronchodilator) from baseline after 24 weeks
Time frame: Baseline up to week 24
The change in trough FEV1 (pre-bronchodilator) from baseline after 52weeks
Time frame: Baseline up to week 52
The change in FEV1 from baseline after 52 weeks of bronchodilator use
Time frame: Baseline up to week 52
The annualized incidence rate of severe AECOPD within 52 weeks
Time frame: Baseline up to week 52
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
40 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TQC2938 injection in people with Chronic Obstructive Pulmonary Disease, run by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. at 40 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 9 inclusion and 29 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 7 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 40 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?
The annualized incidence rate of moderate to severe acute exacerbations of chronic obstructive pulmonary disease (AECOPD within 24 weeks (time frame: Baseline up to week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Apr 2026.