A Study of CM310 in Subjects With Moderate to Severe Asthma

Asthma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05186909
• Other study ID #: CM310-CSP-001
• Status: Completed
• Phase: Phase 2
• Start date: January 12, 2022
• Est. completion date: September 13, 2023

Study information

• Verified date: December 2021
• Source: Keymed Biosciences Co.Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: September 13, 2023
• Est. primary completion date: September 13, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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-4Ra 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.).

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• CM310
CM310 Recombinant Humanized Monoclonal Antibody Injection

Other:
• Placebo
Placebo

Locations

Country	Name	City	State
China	China-Japan Friendship Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Keymed Biosciences Co.Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 weeks
Secondary	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.	24 weeks
Secondary	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.	24 weeks
Secondary	Annualized rate of subjects experiencing severe asthma exacerbations.	Annualized rate of subjects experiencing severe asthma exacerbations during the 24-week randomized treatment period.	24 weeks
Secondary	Time to the first onset of the severe asthma exacerbation event.	Time from baseline to the first onset of the severe asthma exacerbation event.	24 weeks
Secondary	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.	24 weeks
Secondary	Time to the onset of the first event of LOAC.	Time from baseline to the onset of the first event of LOAC.	24 weeks
Secondary	FEV1 percentage of predicted value (FEV1% Pred)	FEV1 percentage of predicted value (FEV1% Pred)	32 weeks
Secondary	Peak diurnal and nocturnal expiratory flow (PEF)	Peak diurnal and nocturnal expiratory flow (PEF)	32 weeks
Secondary	Forced vital capacity (FVC)	Forced vital capacity (FVC)	32 weeks
Secondary	Maximal mid-expiratory flow (MMEF)	Maximal mid-expiratory flow (MMEF)	32 weeks
Secondary	Change from baseline of FEV1 after the use of bronchodilator.	Change from baseline of FEV1 after the use of bronchodilator.	32 weeks
Secondary	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.	32 weeks
Secondary	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).	32 weeks
Secondary	Incidence of Adverse events (AEs)	Incidence of AEs, including any abnormal physical examinations, abnormal vital signs, abnormal ECG, and abnormal lab testing.	32 weeks
Secondary	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.	32 weeks
Secondary	Human thymus and activation-regulated chemokine (TARC)	Change from baseline in TARC at each evaluation time point for each dose group.	32 weeks
Secondary	Fractional exhaled nitric oxide (FeNO).	Change from baseline in FeNO at each evaluation time point for each dose group.	32 weeks
Secondary	Total IgE (immunoglobulin E)	Change from baseline in total IgE at each evaluation time point for each dose group.	32 weeks
Secondary	Anti-drug antibodies (ADAs) and neutralizing antibodies (Nabs).	Incidence of anti-drug antibodies (ADAs) and neutralizing antibodies (Nabs) (if applicable).	32 weeks