This study is a multi-center, randomized, double-blind, placebo-controlled Phase Ⅲ clinical study to evaluate the efficacy, safety, PK characteristics, PD effects and immunogenicity of CM326 in subjects with moderate to severe asthma.
The study consists of three periods, including an up to 4-week screening period, a 52-week double-blind randomized treatment period, and a 12-week safety follow-up period.
Understand the study and voluntarily sign the informed consent form.
Age ≥18 and ≤80 years old, male or female, weight ≥40 kg.
The subject has been diagnosed with asthma for at least 1 year.
Pre-bronchodilator FEV1 measured ≤80% of the normal predicted value.
Chronic obstructive pulmonary disease (COPD) without asthma or other lung disease that may impair lung function, as judged by the investigator.
Have systemic diseases other than asthma that result in an elevated peripheral blood eosinophil count or other diseases such as helminth parasitic infections for which standard treatment is not received or does not respond.
Prior autoimmune disease or inflammatory treatment with biologic agents/systemic immunosuppressive agents within 8 weeks or 5 half-lives (whichever is longer) prior to informed consent.
Previous history of known or suspected immunosuppression, including a history of invasive opportunistic infection, even if the infection has resolved; or the presence of unusual frequent, recurrent, or prolonged infections.
Parallel
CM326
Drugsubcutaneous injection
Placebo
Other interventionsubcutaneous injection
Annualized rate of severe asthma exacerbations at Week 52
Severe asthma exacerbation is defined as worsening of asthma that leads to any of the following: use of systemic corticosteroids for at least 3 days, an emergency department visit due to asthma that required systemic corticosteroids, or an inpatient hospitalization due to asthma. The annualized rate of severe asthma exacerbations is presented as the total number of exacerbations for the treatment group divided by the total duration of person follow-up.
Change from baseline in pre-bronchodilator forced expiratory volume in 1 second (FEV1) at Week 52
Change from baseline in forced expiratory volume in 1 second taken before bronchodilator use will be reported.
Annualized rate of subjects experiencing the event of loss of asthma control (LOAC) at Week 52
A loss of asthma control (LOAC) event refers to any of the following situations experienced by the participants: continuous use of rescue medication, a decrease in FEV1 compared to baseline, an increase in ICS compared to baseline, a decrease in morning or evening PEF, or a severe asthma exacerbation.
Annualized rate of severe asthma exacerbations associated with emergency room visit, or hospitalization at Week 52
Severe asthma exacerbation which leads to an emergency department visit.
Time to the first onset of the severe asthma exacerbation event
Severe asthma exacerbation is defined as worsening of asthma that leads to any of the following: use of systemic corticosteroids for at least 3 days, an emergency department visit due to asthma that required systemic corticosteroids, and an inpatient hospitalization due to asthma. Time to first severe asthma exacerbation will be reported.
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