A Study of CM310 in Subjects With Moderate to Severe Asthma
- Registration Number
- NCT05186909
- Lead Sponsor
- Keymed Biosciences Co.Ltd
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 52
- 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.
- 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.).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Subcutaneous injection (SC), once every 2 weeks (Q2W) for a total of 12 doses. CM310 150mg Q2W 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. CM310 300mg Q2W CM310 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.
- Primary Outcome Measures
Name Time Method Change from baseline in pre-bronchodilator FEV1 (forced expiratory volume in 1 second) at 12 weeks. 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
Name Time Method Annualized rate of subjects experiencing severe asthma exacerbations. 24 weeks 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. 24 weeks Time from baseline to the first onset of the severe asthma exacerbation event.
FEV1 percentage of predicted value (FEV1% Pred) 32 weeks FEV1 percentage of predicted value (FEV1% Pred)
Peak diurnal and nocturnal expiratory flow (PEF) 32 weeks Peak diurnal and nocturnal expiratory flow (PEF)
Change from baseline in pre-bronchodilator FEV1 at each evaluation time point. 24 weeks Absolute change from baseline in pre-bronchodilator FEV1 at each evaluation time point.
Time to the onset of the first event of LOAC. 24 weeks Time from baseline to the onset of the first event of LOAC.
Incidence of Adverse events (AEs) 32 weeks Incidence of AEs, including any abnormal physical examinations, abnormal vital signs, abnormal ECG, and abnormal lab testing.
Human thymus and activation-regulated chemokine (TARC) 32 weeks Change from baseline in TARC at each evaluation time point for each dose group.
Fractional exhaled nitric oxide (FeNO). 32 weeks Change from baseline in FeNO at each evaluation time point for each dose group.
Total IgE (immunoglobulin E) 32 weeks Change from baseline in total IgE at each evaluation time point for each dose group.
Percent change from baseline in pre-bronchodilator FEV1 at each evaluation time point. 24 weeks Percent change from baseline in pre-bronchodilator FEV1 at each evaluation time point.
Annualized rate of subjects experiencing the event of loss of asthma control (LOAC). 24 weeks Annualized rate of subjects experiencing the event of loss of asthma control (LOAC) during the 24-week randomized treatment period.
Maximal mid-expiratory flow (MMEF) 32 weeks Maximal mid-expiratory flow (MMEF)
Change from baseline of FEV1 after the use of bronchodilator. 32 weeks Change from baseline of FEV1 after the use of bronchodilator.
Forced vital capacity (FVC) 32 weeks Forced vital capacity (FVC)
Change from baseline in the Asthma Control Questionnaire-5 (ACQ-5) score at each evaluation time point. 32 weeks 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. 32 weeks 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).
Anti-drug antibodies (ADAs) and neutralizing antibodies (Nabs). 32 weeks Incidence of anti-drug antibodies (ADAs) and neutralizing antibodies (Nabs) (if applicable).
Trough concentration at steady-state of CM310 32 weeks 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.
Trial Locations
- Locations (1)
China-Japan Friendship Hospital
🇨🇳Beijing, China