A Clinical Study to Evaluate the Efficacy and Safety of TQC2938 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease
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
1 other identifier
interventional
256
1 country
40
Brief 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). It is anticipated that 256 subjects will be enrolled.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 chronic-obstructive-pulmonary-disease
Started Apr 2025
Typical duration for phase_2 chronic-obstructive-pulmonary-disease
40 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 17, 2025
CompletedFirst Posted
Study publicly available on registry
January 23, 2025
CompletedStudy Start
First participant enrolled
April 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2027
January 23, 2025
November 1, 2024
2.7 years
January 17, 2025
January 17, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Baseline up to week 24
Secondary Outcomes (6)
Safety and tolerability assessment
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
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
Baseline up to week 24
The change in trough FEV1 (pre-bronchodilator) from baseline after 52weeks
Baseline up to week 52
The change in FEV1 from baseline after 52 weeks of bronchodilator use
Baseline up to week 52
- +1 more secondary outcomes
Study Arms (2)
TQC2938 injection
EXPERIMENTALTQC2938 injection is injected subcutaneously every 28 days for a treatment cycle of 52 weeks.
TQC2938 injection Placebo
PLACEBO COMPARATORSubcutaneous injection of 0 mg TQC2938 injection solution, with a treatment cycle of every 28 days, for a total of 52 weeks.
Interventions
TQC2938 is a humanized monoclonal antibody that interfering with the signal cascade.
TQC2938 is a humanized monoclonal antibody that interfering with the signal cascade.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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;
- +14 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (40)
An Hui Chest Hospital
Hefei, Anhui, 230000, China
China-Japan Friendship Hospital
Beijing, Beijing Municipality, 100029, China
Peking University First Hospital
Beijing, Beijing Municipality, 100034, China
Peolpe's Hospital Of Chongqing Banan District
Chongqing, Chongqing Municipality, 400054, China
Shunde Hospital Of Southern Medical University
Foshan, Guangdong, 528308, China
Jiangmen Central Hospital
Jiangmen, Guangdong, 529000, China
Liuzhou municipal liutie central hospital
Liuchow, Guangxi, 545007, China
The First People' Hospital Of YuLin
Yulin, Guangxi, 537000, China
Cangzhou Central Hospital
Cangzhou, Hebei, 061000, China
Xingtai People's Hospital
Xingtai, Hebei, 54000, China
The second hospital of hebei medical university
Shijiazhuang, Heibei, 05000, China
The First Affiliated Hospital of Jiamusi University
Jiamusi, Heilongjiang, 154003, China
The First Hospital of Qiqihar
Qiqihar, Heilongjiang, 161005, China
Puyang Oilfield General Hospital
Puyang, Henan, 457001, China
The First People's Hospital of Xinxiang City
Xinxiang, Henan, 453000, China
Yongcheng People's Hospital
Yongcheng, Henan, 476600, China
Henan Chest Hospital
Zhengzhou, Henan, 450000, China
The second xiangya hospital of central south university
Changsha, Hunan, 410011, China
Shaoyang Central Hospital
Shaoyang, Hunan, 422000, China
The Affiliated Hospital of Mongolia Medical College
Hohhot, Inner Mongolia, 010000, China
Affiliated Hospital of Jiangsu University
Zhenjiang, Jiangsu, 212050, China
Jiangxi Provincal People's Hospital
Nanchang, Jiangxi, 330000, China
Meihekou Central Hospital
Meihekou, Jilin, 135000, China
Siping Central People's Hospital
Siping, Jilin, 136099, China
Heze Municipal Hospital
Heze, Shandong, China
Weifang NO.2 People' Hospital
Weifang, Shandong, 261041, China
Shanghai JiaoTong University of medicine Ruijin Hospital
Shanghai, Shanghai Municipality, 20025, China
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, 200433, China
Linfen Central Hospital
Linfen, Shanxi, 041099, China
Xi'An International Medicl Center Hospital
Xi’an, Shanxi, 710061, China
Affiliated Hospital Of ChengDu University
Chengdu, Sichuan, 610081, China
Leshan People's Hospital
Leshan, Sichuan, 614099, China
Suining Central Hospital
Suining, Sichuan, 629000, China
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, 300041, 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
Jinhua Municipal Centeral Hospital Medical Group
Jinhua, Zhejiang, 321000, China
The First Affiliated Hospitial Of Ningbo University
Ningbo, Zhejiang, 315211, 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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 17, 2025
First Posted
January 23, 2025
Study Start
April 1, 2025
Primary Completion (Estimated)
December 1, 2027
Study Completion (Estimated)
December 1, 2027
Last Updated
January 23, 2025
Record last verified: 2024-11