This study is a multi-center, randomized, double-blind, placebo-controlled Phase Ⅱ 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 treatment period, and a 12-week safety follow-up period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
207
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, China
RECRUITINGAnnualized rate of subjects experiencing severe asthma exacerbations
Annualized rate of subjects experiencing severe asthma exacerbations during the 24-week randomized treatment period.
Time frame: 24 weeks
Annualized rate of subjects experiencing the event of loss of asthma control (LOAC)
Annualized rate of subjects experiencing the event of loss of asthma control (LOAC) during the 24-week randomized treatment period.
Time frame: 24 weeks
Change from baseline in pre-bronchodilator forced expiratory volume in 1 second (FEV1)
Change from baseline in pre-bronchodilator FEV1 at each evaluation time point.
Time frame: 64 weeks
Rate of change from baseline in pre-bronchodilator FEV1
Rate of change from baseline in pre-bronchodilator FEV1 at each evaluation time point.
Time frame: 64 weeks
Time to the first onset of the severe asthma exacerbation event
Time from baseline to the first onset of the severe asthma exacerbation event.
Time frame: 52 weeks
Time to the onset of the first event of LOAC
Time from baseline to the onset of the first event of LOAC.
Time frame: 52 weeks
Change from baseline in FEV1 percentage of predicted value (FEV1% Pred)
Change from baseline in FEV1% Pred at each evaluation time
Time frame: 64 weeks
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Change from baseline in Peak diurnal and nocturnal expiratory flow (PEF)
Change from baseline in PEF at each evaluation time
Time frame: 64 weeks
Change from baseline in Forced vital capacity (FVC)
Change from baseline in FVC at each evaluation time
Time frame: 64 weeks
Change from baseline in Forced Expiratory Flow (FEF) 25-75%
Change from baseline in 25-75%FEF at each evaluation time
Time frame: 64 weeks
Change from baseline in FEV1 after the use of bronchodilator
Change from baseline in FEV1 after the use of bronchodilator at each evaluation time
Time frame: 64 weeks
Change from baseline in the Asthma Control Questionnaire-5 (ACQ-5) score at each evaluation time point
Change from baseline in the ACQ-5 score at each evaluation time point
Time frame: 64 weeks
Change from baseline in asthma symptom score at each evaluation time point
Change from baseline in asthma symptom score at each evaluation time point
Time frame: 64 weeks
Change from baseline in the Standardized Asthma Quality of Life Questionnaire (AQLQ(S)) score at each evaluation time point
Change from baseline in the AQLQ(S) score at each evaluation time point
Time frame: 64 weeks
Change from baseline in the number of inhalations of SABA
Change from baseline in the number of inhalations of SABA at each evaluation time
Time frame: 64 weeks
Incidence of Adverse events (AEs)
Incidence of AEs, including any abnormal physical examinations, abnormal vital signs, abnormal ECG, and abnormal lab testing.
Time frame: 64 weeks
Pharmacokinetic profile of CM326
Maximum Plasma Concentration(Cmax)of CM326
Time frame: 64 weeks
Immunogenicity
Incidence of anti-drug antibodies (ADAs) and neutralizing antibodies (Nabs) (if applicable).
Time frame: 64 weeks