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
Overview
- Phase
- Phase 2
- Intervention
- CM310
- Conditions
- Asthma
- Sponsor
- Keymed Biosciences Co.Ltd
- Enrollment
- 52
- Locations
- 1
- Primary Endpoint
- Change from baseline in pre-bronchodilator FEV1 (forced expiratory volume in 1 second) at 12 weeks.
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
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.).
Arms & Interventions
CM310 300mg Q2W
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.
Intervention: CM310
CM310 150mg Q2W
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.
Intervention: CM310
Placebo
Subcutaneous injection (SC), once every 2 weeks (Q2W) for a total of 12 doses.
Intervention: Placebo
Outcomes
Primary Outcomes
Change from baseline in pre-bronchodilator FEV1 (forced expiratory volume in 1 second) at 12 weeks.
Time Frame: 12 weeks
Absolute change from baseline in pre-bronchodilator FEV1 in each dose group at 12 weeks of CM310 treatment compared with placebo.
Secondary Outcomes
- FEV1 percentage of predicted value (FEV1% Pred)(32 weeks)
- Peak diurnal and nocturnal expiratory flow (PEF)(32 weeks)
- Annualized rate of subjects experiencing severe asthma exacerbations.(24 weeks)
- Time to the first onset of the severe asthma exacerbation event.(24 weeks)
- Change from baseline in pre-bronchodilator FEV1 at each evaluation time point.(24 weeks)
- Time to the onset of the first event of LOAC.(24 weeks)
- Incidence of Adverse events (AEs)(32 weeks)
- Human thymus and activation-regulated chemokine (TARC)(32 weeks)
- Fractional exhaled nitric oxide (FeNO).(32 weeks)
- Total IgE (immunoglobulin E)(32 weeks)
- Percent change from baseline in pre-bronchodilator FEV1 at each evaluation time point.(24 weeks)
- Annualized rate of subjects experiencing the event of loss of asthma control (LOAC).(24 weeks)
- Maximal mid-expiratory flow (MMEF)(32 weeks)
- Change from baseline of FEV1 after the use of bronchodilator.(32 weeks)
- Forced vital capacity (FVC)(32 weeks)
- Change from baseline in the Asthma Control Questionnaire-5 (ACQ-5) score at each evaluation time point.(32 weeks)
- Change from baseline in asthma symptom score at each evaluation time point.(32 weeks)
- Anti-drug antibodies (ADAs) and neutralizing antibodies (Nabs).(32 weeks)
- Trough concentration at steady-state of CM310(32 weeks)