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

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.

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.