This study is a multi-center, randomized, double-blind, placebo-controlled Phase Ⅱ/Ⅲ clinical study to evaluate the efficacy, safety, PK characteristics, PD effects and immunogenicity of CM310 in subjects with moderate to severe Chronic Obstructive Pulmonary Disease（COPD）.
The study has two parts. Each part consists of three periods, including an up to 4-week screening period, a 52-week randomized treatment period, and a 8-week safety follow-up period.
Have the ability to understand the nature of the study and voluntarily sign the informed consent form.
Age ≥40 and ≤85 years old, male or female, at the time of signing the informed consent.
The patient has been diagnosed with COPD for at least 1 year, and meet the following criteria at screening.
Moderate to severe COPD (post-bronchodilator FEV1/FVC ratio <0.70 and post-bronchodilator FEV1 % predicted >30% and ≤70%) at screening.
A current diagnosis of asthma or history of asthma according to the Global Initiative for Asthma (GINA) guidelines or other accepted guidelines（asthma alone or asthma as the primary diagnosis, including but not limited to asthma with COPD）.
Subjects with significant pulmonary disease other than COPD (e.g., sarcoidosis, interstitial lung disease, primary pulmonary hypertension, bronchiectasis, Churg-Strauss Syndrome, active tuberculosis or non-tuberculous mycobacterial infection, etc.), in the opinion of the investigator.
Subjects with other conditions that could lead to elevated eosinophils such as hypereosinophilic syndromes, eosinophilic granulomatosis with polyangiitis (EGPA), eosinophilic esophagitis or other disease(e.g., active parasitic infection (helminthes) which has not been treated with, or has failed to respond to standard of care therapy.)
Heart failure NYHA Class IV, uncontrolled Cor pulmonale as judged by the Investigator or with evidence of right cardiac failure.
Parallel
CM310
DrugCM310 Recombinant Humanized Monoclonal Antibody Injection
Placebo
DrugPlacebo
Annualized Rate of Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Acute Exacerbations
Moderate acute exacerbation of COPD (AECOPD) are defined as exacerbations that require either systemic corticosteroids (intramuscular, intravenous, or oral) and/or antibiotics. Severe AECOPD are defined as exacerbations requiring hospitalization or observation \>24 hours in emergency department/urgent care facility. For both moderate and severe events to be counted as separate events, they are separated by at least 14 days. Annualized event rate are the total number of exacerbations that occure during the treatment period divided by the total number of participant-years treated.
Time to First Moderate or Severe Acute Exacerbation of COPD (AECOPD)
The time to first moderate or severe exacerbation is defined as date of the first event minus randomization date +1. The median time to first severe exacerbation is derived from Cox regression model.
Annualized Rate of Severe Acute Exacerbations of COPD
Severe AECOPD are defined as exacerbations requiring hospitalization or observation \>24 hours in emergency department/urgent care facility. For severe events to be counted as separate events, they are separated by at least 14 days. Annualized event rate are the total number of exacerbations that occure during the treatment period divided by the total number of participant-years treated.
Change from baseline in pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at week 12
The FEV1 is the volume of air exhaled from the lungs in the first second of a forced expiration as measured by spirometer. Spirometry is performed after a wash out period of bronchodilators according to their action duration.
Change from baseline in pre-bronchodilator FEV1 at week 52
The FEV1 is the volume of air exhaled from the lungs in the first second of a forced expiration as measured by spirometer. Spirometry is performed after a wash out period of bronchodilators according to their action duration.
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