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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CM326 | Experimental | CM326 subcutaneous (SC) |
|
| Placebo | Placebo Comparator | placebo, subcutaneous (SC) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CM326 | Drug | subcutaneous injection |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | week 52 |
| Annualized rate of subjects experiencing the event of loss of asthma control (LOAC) at Week 52 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials Information Group officer | Contact | 031169085587 | ctr-contact@cspc.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ruijin Hospital, Shanghai Jiao tong University School of Medicine | Recruiting | Shanghai | Shanghai Municipality | 200000 | China |
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Randomized, double-blind, placebo-controlled
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| Other |
subcutaneous injection |
|
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. |
| week 52 |
| 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. | week 52 |
| 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. | week 52 |
| Time to the onset of the first event of LOAC | Time to first LOAC event will be reported. | week52 |
| Change from baseline in Pre-bronchodilator FEV1 percentage of predicted value (FEV1% Pred) at each evaluation time point | Change from baseline in the ratio of FEV1 to the predicted value taken before bronchodilator use will be reported. | week 52 |
| Change from baseline in Pre-bronchodilator Forced vital capacity (FVC) at each evaluation time point | Change from baseline in forced vital capacity taken before bronchodilator use will be reported. | week 52 |
| Change from baseline in Pre-bronchodilator Maximal Mid-Expiratory FlowForced Expiratory Flow (MMEF) at each evaluation time point | Change from baseline in maximal mid-expiratory flow taken before bronchodilator use will be reported. | week 52 |
| Change from baseline in post-bronchodilator FEV1 at each evaluation time point | Change from baseline in forced expiratory volume in 1 second taken after bronchodilator use will be reported. | week 52 |
| Change from baseline in weekly mean morning and evening peak expiratory flow (PEF) at each evaluation time | The mean weekly daytime PEF is calculated as the average of daytime PEF measurements from Day -6 through the visit day. The mean weekly nocturnal PEF is calculated as the average of nighttime PEF measurements from Day -7 through Day -1 prior to the visit. | week 52 |
| Change from baseline in the Asthma Control Questionnaire-6(ACQ-6) score at each evaluation time point | Asthma Control Questionnaire-6(ACQ-6) is a questionnaire consisting of 6 questions used to evaluate the degree of asthma control in the past week. The score of each question ranges from 0 to 6 (on a 7-point scale), with a higher score indicating poorer symptom control. The mean ACQ-6 score is the mean of the 6 questions. | week 52 |
| Proportion of participants with an ACQ-6 Score improvement of ≥0.5 points from baseline at each evaluation time point | Individual changes of at least 0.5 are considered to be clinically meaningful, and a decrease of at least 0.5 is the responder definition for ACQ-6. | week 52 |
| Change from baseline in the Standardized Asthma Quality of Life Questionnaire (AQLQ(S)+12) score at each evaluation time point | Asthma Quality of Life Questionnaire (AQLQ(S)+12)is a questionnaire consisting of 32 questions used to evaluate the quality of life of asthma participants in the past 2 weeks. Each question is scored from 1 to 7 (on a 7-point scale) based on the severity, with a higher score indicating better quality of life. | week 52 |
| Proportion of participants with an (AQLQ(S)+12) Score improvement of ≥0.5 points from baseline at each evaluation time point | The responder definition for AQLQ(s)+12 is 0.5-point improvement from baseline. | week 52 |
| Change from baseline in asthma symptom score at each evaluation time point | The asthma symptom score comprises 10 items (5 for the morning and 5 for the night). The item scores range from "0" (no symptoms, no nocturnal awakenings, or no activity limitation) to "4" (very severe symptoms, inability to sleep, or extreme activity limitation). The daily asthma symptom diary score is the average of 10 items (the night assessment value of the previous day and the morning assessment value of the next day). | week 52 |
| Change from baseline in weekly mean rescue medication use at each evaluation | Change from baseline in the average weekly dose of rescue medication will be reported. | week 52 |
| Change from baseline in European Quality of Life - 5 Dimensions 5 Levels Questionnaire (EQ-5D-5L) score at each evaluation time point | The European Quality of Life - 5 Dimensions 5 Levels Questionnaire (EQ-5D-5L) questionnaire assesses 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 response options (no problems, slight problems, moderate problems, severe problems, and extreme problems), reflecting the increasing levels of difficulty. The questionnaire also includes a visual analog scale, where participants will rate their current health status within the range of 0 to 100, with 0 representing the worst imaginable health state and 100 indicated the best health state | week 52 |
| Incidence and severity of Adverse events (AEs) | The severity of adverse events is recorded using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), version 6.0. The incidence of participants with adverse events (AE) will be calculated. | week 64 |
| Blood drug concentration of CM326 | week 64 |
| Change from baseline fractional exhaled nitric oxide (FeNO) | Evaluate the changes from baseline in FeNO at each visit point. | week 64 |
| Change from baseline in peripheral blood eosinophil | Evaluate the changes from baseline in blood eosinophil count at each visit point. | week 64 |
| Change from baseline in total serum IgE | Evaluate the changes from baseline in total serum IgE at each visit point. | week 64 |
| Change from baseline in interleukin-5 | Evaluate the changes from baseline in blood serum IgE at each visit point. | week 64 |
| Incidence of anti-drug antibodies (ADAs) | week 64 |