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Completed

NCT Number: NCT05186909

A Study of CM310 in Subjects With Moderate to Severe Asthma

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.

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

China-Japan Friendship Hospital

Beijing, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.).

Treatment and study plan

CM310

Drug

CM310 Recombinant Humanized Monoclonal Antibody Injection

Placebo

Other

Placebo

Primary outcomes

  1. 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

  1. Change from baseline in pre-bronchodilator FEV1 at each evaluation time point.

    Time frame: 24 weeks

    Absolute change from baseline in pre-bronchodilator FEV1 at each evaluation time point.

  2. Percent change from baseline in pre-bronchodilator FEV1 at each evaluation time point.

    Time frame: 24 weeks

    Percent change from baseline in pre-bronchodilator FEV1 at each evaluation time point.

  3. Annualized rate of subjects experiencing severe asthma exacerbations.

    Time frame: 24 weeks

    Annualized rate of subjects experiencing severe asthma exacerbations during the 24-week randomized treatment period.

  4. Time to the first onset of the severe asthma exacerbation event.

    Time frame: 24 weeks

    Time from baseline to the first onset of the severe asthma exacerbation event.

  5. Annualized rate of subjects experiencing the event of loss of asthma control (LOAC).

    Time frame: 24 weeks

    Annualized rate of subjects experiencing the event of loss of asthma control (LOAC) during the 24-week randomized treatment period.

  6. Time to the onset of the first event of LOAC.

    Time frame: 24 weeks

    Time from baseline to the onset of the first event of LOAC.

  7. FEV1 percentage of predicted value (FEV1% Pred)

    Time frame: 32 weeks

    FEV1 percentage of predicted value (FEV1% Pred)

  8. Peak diurnal and nocturnal expiratory flow (PEF)

    Time frame: 32 weeks

    Peak diurnal and nocturnal expiratory flow (PEF)

  9. Forced vital capacity (FVC)

    Time frame: 32 weeks

    Forced vital capacity (FVC)

  10. Maximal mid-expiratory flow (MMEF)

    Time frame: 32 weeks

    Maximal mid-expiratory flow (MMEF)

  11. Change from baseline of FEV1 after the use of bronchodilator.

    Time frame: 32 weeks

    Change from baseline of FEV1 after the use of bronchodilator.

  12. Change from baseline in the Asthma Control Questionnaire-5 (ACQ-5) score at each evaluation time point.

    Time frame: 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.

  13. Change from baseline in asthma symptom score at each evaluation time point.

    Time frame: 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).

  14. Incidence of Adverse events (AEs)

    Time frame: 32 weeks

    Incidence of AEs, including any abnormal physical examinations, abnormal vital signs, abnormal ECG, and abnormal lab testing.

  15. Trough concentration at steady-state of CM310

    Time frame: 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.

  16. Human thymus and activation-regulated chemokine (TARC)

    Time frame: 32 weeks

    Change from baseline in TARC at each evaluation time point for each dose group.

  17. Fractional exhaled nitric oxide (FeNO).

    Time frame: 32 weeks

    Change from baseline in FeNO at each evaluation time point for each dose group.

  18. Total IgE (immunoglobulin E)

    Time frame: 32 weeks

    Change from baseline in total IgE at each evaluation time point for each dose group.

  19. Anti-drug antibodies (ADAs) and neutralizing antibodies (Nabs).

    Time frame: 32 weeks

    Incidence of anti-drug antibodies (ADAs) and neutralizing antibodies (Nabs) (if applicable).

Sponsors and collaborators

Lead sponsor

Keymed Biosciences Co.Ltd

Industry

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jan 11, 2022
Registry last updated
Feb 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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