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 asthma.
The study consists of three periods, including an up to 4-week screening period, a 52-week randomized treatment period, and a 4-week safety follow-up period.
Have the ability to understand the study and voluntarily sign the informed consent form.
Age ≥12 and ≤75 years old, male or female, weight ≥40 kg.
The subject has been diagnosed with asthma for at least 1 year, and the current disease status meets the diagnostic criteria of GINA 2022.
Pre-bronchodilator FEV1 measured ≤ 80% of the normal predicted value at screening and baseline visits (V1 and V2).
Received biological agents with the same therapeutic purpose within 6 months before signing the informed consent.
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.
Received immune globulin or blood products within 30 days before informed consent.
Subjects treated with systemic corticosteroids (except for topical, ophthalmic, or intranasal corticosteroids) from 4 weeks before signing the informed consent to the date of randomization.
Parallel
CM310
DrugCM310 Recombinant Humanized Monoclonal Antibody Injection
Placebo
Other interventionPlacebo
Annualized rate of severe asthma exacerbations
Change from baseline in pre-bronchodilator Forced expiratory volume in 1 second (FEV1) at Week 12
Rate of change from baseline in pre-bronchodilator FEV1 at Week 12
Change from baseline in FEV1 percentage of predicted value (FEV1% Pred)
Change from baseline in Peak diurnal and nocturnal expiratory flow (PEF)
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