A Phase 2 interventional study of CM310 and Placebo in Asthma, sponsored by Keymed Biosciences Co.Ltd. Completed at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-02-28.
Sponsored by Keymed Biosciences Co.Ltd · Phase 2, Interventional, and Treatment
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 CM310 in subjects with moderate to severe asthma.
The study consists of three periods, including an up to 4-week screening period, a 24-week randomized treatment period, and a 8-week safety follow-up period.
3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.
This study's enrollment of 52 is below the median of 83 across 2,752 interventional studies indexed under Asthma.
Browse Asthma studies →Keymed Biosciences Co.Ltd is the lead sponsor of 63 studies on the registry; 31 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
CM310 is injected subcutaneously (SC) with a loading dose of 600 mg at the first dose, and then 300 mg each time, once every 2 weeks (Q2W) for a total of 12 doses.
Drug: CM310
CM310 is injected subcutaneously (SC) with a loading dose of 300 mg at the first dose, and then 150 mg each time, once every 2 weeks (Q2W) for a total of 12 doses.
Drug: CM310
Subcutaneous injection (SC), once every 2 weeks (Q2W) for a total of 12 doses.
Other: Placebo
CM310 Recombinant Humanized Monoclonal Antibody Injection
Placebo
Change from baseline in pre-bronchodilator FEV1 (forced expiratory volume in 1 second) at 12 weeks.
Absolute change from baseline in pre-bronchodilator FEV1 in each dose group at 12 weeks of CM310 treatment compared with placebo.
Time frame: 12 weeks
Change from baseline in pre-bronchodilator FEV1 at each evaluation time point.
Absolute change from baseline in pre-bronchodilator FEV1 at each evaluation time point.
Time frame: 24 weeks
Percent change from baseline in pre-bronchodilator FEV1 at each evaluation time point.
Percent change from baseline in pre-bronchodilator FEV1 at each evaluation time point.
Time frame: 24 weeks
Annualized 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
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: 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
Time to the onset of the first event of LOAC.
Time from baseline to the onset of the first event of LOAC.
Time frame: 24 weeks
FEV1 percentage of predicted value (FEV1% Pred)
FEV1 percentage of predicted value (FEV1% Pred)
Time frame: 32 weeks
Peak diurnal and nocturnal expiratory flow (PEF)
Peak diurnal and nocturnal expiratory flow (PEF)
Time frame: 32 weeks
Forced vital capacity (FVC)
Forced vital capacity (FVC)
Time frame: 32 weeks
Maximal mid-expiratory flow (MMEF)
Maximal mid-expiratory flow (MMEF)
Time frame: 32 weeks
Change from baseline of FEV1 after the use of bronchodilator.
Change from baseline of FEV1 after the use of bronchodilator.
Time frame: 32 weeks
Change from baseline in the Asthma Control Questionnaire-5 (ACQ-5) score at each evaluation time point.
The ACQ-5 is a questionnaire used to evaluate the degree of asthma control. Each question is scored from 0 to 6 (on a 7-point scale) according to its severity. The higher the score, the less satisfactory symptom control is.
Time frame: 32 weeks
Change from baseline in asthma symptom score at each evaluation time point.
Patients will record total symptom scores in morning（a 0-4 scale, with 0=no symptoms, 4=inability to fall asleep at night due to symptoms) and afternoon (a 0-5 scale, with 0=no symptoms, 5=severe symptoms, unable to work or perform daily activities).
Time frame: 32 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: 32 weeks
Trough concentration at steady-state of CM310
To evaluate the trough concentration at steady-state of CM310 for each dose group. Population pharmacokinetic analysis is performed using a nonlinear mixed-effects model.
Time frame: 32 weeks
Human thymus and activation-regulated chemokine (TARC)
Change from baseline in TARC at each evaluation time point for each dose group.
Time frame: 32 weeks
Fractional exhaled nitric oxide (FeNO).
Change from baseline in FeNO at each evaluation time point for each dose group.
Time frame: 32 weeks
Total IgE (immunoglobulin E)
Change from baseline in total IgE at each evaluation time point for each dose group.
Time frame: 32 weeks
Anti-drug antibodies (ADAs) and neutralizing antibodies (Nabs).
Incidence of anti-drug antibodies (ADAs) and neutralizing antibodies (Nabs) (if applicable).
Time frame: 32 weeks
This study is completed, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.
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