Back to resultsA Study of CM310 in Subjects With Moderate to Severe Asthma
Primary Purpose
Asthma
Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
CM310
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Asthma
Eligibility Criteria
Inclusion Criteria:
- Subjects are able to understand the nature of the study and voluntarily sign the ICF.
- Diagnosed with asthma according to the 2021 version of the GINA guidelines for at least 1 year.
- Pre-bronchodilator FEV1 measurement ≤ 80% of predicted normal value.
- Subjects must have experienced a severe asthma exacerbation within 12 months prior to screening, and have not experienced a severe asthma exacerbation within 1 month prior to screening.
Exclusion Criteria:
- Women of childbearing potential have a positive pregnancy test result during the screening period; women who are pregnant or lactating.
- Received biologics with the same therapeutic purpose within 6 months prior to screening, such as similar IL-4Rα antagonist, IL-5/5R, anti-IgE monoclonal antibody (mAb).
- Diagnosed with chronic obstructive pulmonary disease (COPD) or other lung disorders that may compromise lung function (including but not limited to idiopathic pulmonary fibrosis, allergic granulomatous angiitis, bronchopulmonary aspergillosis allergic, pulmonary tuberculosis, etc.).
Sites / Locations
- China-Japan Friendship HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
CM310 300mg Q2W
CM310 150mg Q2W
Placebo
Arm Description
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.
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.
Subcutaneous injection (SC), once every 2 weeks (Q2W) for a total of 12 doses.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Annualized rate of subjects experiencing severe asthma exacerbations.
Annualized rate of subjects experiencing severe asthma exacerbations during the 24-week randomized treatment period.
Time to the first onset of the severe asthma exacerbation event.
Time from baseline to the first onset of the severe asthma exacerbation event.
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 to the onset of the first event of LOAC.
Time from baseline to the onset of the first event of LOAC.
FEV1 percentage of predicted value (FEV1% Pred)
FEV1 percentage of predicted value (FEV1% Pred)
Peak diurnal and nocturnal expiratory flow (PEF)
Peak diurnal and nocturnal expiratory flow (PEF)
Forced vital capacity (FVC)
Forced vital capacity (FVC)
Maximal mid-expiratory flow (MMEF)
Maximal mid-expiratory flow (MMEF)
Change from baseline of FEV1 after the use of bronchodilator.
Change from baseline of FEV1 after the use of bronchodilator.
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.
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).
Incidence of Adverse events (AEs)
Incidence of AEs, including any abnormal physical examinations, abnormal vital signs, abnormal ECG, and abnormal lab testing.
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.
Human thymus and activation-regulated chemokine (TARC)
Change from baseline in TARC at each evaluation time point for each dose group.
Fractional exhaled nitric oxide (FeNO).
Change from baseline in FeNO at each evaluation time point for each dose group.
Total IgE (immunoglobulin E)
Change from baseline in total IgE at each evaluation time point for each dose group.
Anti-drug antibodies (ADAs) and neutralizing antibodies (Nabs).
Incidence of anti-drug antibodies (ADAs) and neutralizing antibodies (Nabs) (if applicable).
Full Information
NCT ID
NCT05186909
First Posted
December 9, 2021
Last Updated
February 10, 2022
Sponsor
Keymed Biosciences Co.Ltd
1. Study Identification
Unique Protocol Identification Number
NCT05186909
Brief Title
A Study of CM310 in Subjects With Moderate to Severe Asthma
Official Title
A Randomized, Double-Blind, Placebo-Controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of CM310 Recombinant Humanized Monoclonal Antibody Injection in Subjects With Moderate to Severe Asthma
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Recruiting
Study Start Date
January 12, 2022 (Actual)
Primary Completion Date
August 2023 (Anticipated)
Study Completion Date
August 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Keymed Biosciences Co.Ltd
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
303 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CM310 300mg Q2W
Arm Type
Experimental
Arm Description
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.
Arm Title
CM310 150mg Q2W
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Subcutaneous injection (SC), once every 2 weeks (Q2W) for a total of 12 doses.
Intervention Type
Drug
Intervention Name(s)
CM310
Intervention Description
CM310 Recombinant Humanized Monoclonal Antibody Injection
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Change from baseline in pre-bronchodilator FEV1 (forced expiratory volume in 1 second) at 12 weeks.
Description
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
Secondary Outcome Measure Information:
Title
Change from baseline in pre-bronchodilator FEV1 at each evaluation time point.
Description
Absolute change from baseline in pre-bronchodilator FEV1 at each evaluation time point.
Time Frame
24 weeks
Title
Percent change from baseline in pre-bronchodilator FEV1 at each evaluation time point.
Description
Percent change from baseline in pre-bronchodilator FEV1 at each evaluation time point.
Time Frame
24 weeks
Title
Annualized rate of subjects experiencing severe asthma exacerbations.
Description
Annualized rate of subjects experiencing severe asthma exacerbations during the 24-week randomized treatment period.
Time Frame
24 weeks
Title
Time to the first onset of the severe asthma exacerbation event.
Description
Time from baseline to the first onset of the severe asthma exacerbation event.
Time Frame
24 weeks
Title
Annualized rate of subjects experiencing the event of loss of asthma control (LOAC).
Description
Annualized rate of subjects experiencing the event of loss of asthma control (LOAC) during the 24-week randomized treatment period.
Time Frame
24 weeks
Title
Time to the onset of the first event of LOAC.
Description
Time from baseline to the onset of the first event of LOAC.
Time Frame
24 weeks
Title
FEV1 percentage of predicted value (FEV1% Pred)
Description
FEV1 percentage of predicted value (FEV1% Pred)
Time Frame
32 weeks
Title
Peak diurnal and nocturnal expiratory flow (PEF)
Description
Peak diurnal and nocturnal expiratory flow (PEF)
Time Frame
32 weeks
Title
Forced vital capacity (FVC)
Description
Forced vital capacity (FVC)
Time Frame
32 weeks
Title
Maximal mid-expiratory flow (MMEF)
Description
Maximal mid-expiratory flow (MMEF)
Time Frame
32 weeks
Title
Change from baseline of FEV1 after the use of bronchodilator.
Description
Change from baseline of FEV1 after the use of bronchodilator.
Time Frame
32 weeks
Title
Change from baseline in the Asthma Control Questionnaire-5 (ACQ-5) score at each evaluation time point.
Description
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
Title
Change from baseline in asthma symptom score at each evaluation time point.
Description
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
Title
Incidence of Adverse events (AEs)
Description
Incidence of AEs, including any abnormal physical examinations, abnormal vital signs, abnormal ECG, and abnormal lab testing.
Time Frame
32 weeks
Title
Trough concentration at steady-state of CM310
Description
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
Title
Human thymus and activation-regulated chemokine (TARC)
Description
Change from baseline in TARC at each evaluation time point for each dose group.
Time Frame
32 weeks
Title
Fractional exhaled nitric oxide (FeNO).
Description
Change from baseline in FeNO at each evaluation time point for each dose group.
Time Frame
32 weeks
Title
Total IgE (immunoglobulin E)
Description
Change from baseline in total IgE at each evaluation time point for each dose group.
Time Frame
32 weeks
Title
Anti-drug antibodies (ADAs) and neutralizing antibodies (Nabs).
Description
Incidence of anti-drug antibodies (ADAs) and neutralizing antibodies (Nabs) (if applicable).
Time Frame
32 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects are able to understand the nature of the study and voluntarily sign the ICF.
Diagnosed with asthma according to the 2021 version of the GINA guidelines for at least 1 year.
Pre-bronchodilator FEV1 measurement ≤ 80% of predicted normal value.
Subjects must have experienced a severe asthma exacerbation within 12 months prior to screening, and have not experienced a severe asthma exacerbation within 1 month prior to screening.
Exclusion Criteria:
Women of childbearing potential have a positive pregnancy test result during the screening period; women who are pregnant or lactating.
Received biologics with the same therapeutic purpose within 6 months prior to screening, such as similar IL-4Rα antagonist, IL-5/5R, anti-IgE monoclonal antibody (mAb).
Diagnosed with chronic obstructive pulmonary disease (COPD) or other lung disorders that may compromise lung function (including but not limited to idiopathic pulmonary fibrosis, allergic granulomatous angiitis, bronchopulmonary aspergillosis allergic, pulmonary tuberculosis, etc.).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Qian Jia
Phone
02888610620
Email
qianjia@keymedbio.com
Facility Information:
Facility Name
China-Japan Friendship Hospital
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chen Wang
First Name & Middle Initial & Last Name & Degree
Nan Su
12. IPD Sharing Statement
Learn more about this trial
A Study of CM310 in Subjects With Moderate to Severe Asthma
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