Clinical trial NCT05186909: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Asthma
Lead sponsor: Keymed Biosciences Co.Ltd
Sponsor class: INDUSTRY
First posted: 2022-01-11
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.).

Primary outcomes:
measure: Change from baseline in pre-bronchodilator FEV1 (forced expiratory volume in 1 second) at 12 weeks.
timeFrame: 12 weeks
Secondary outcomes:
measure: Change from baseline in pre-bronchodilator FEV1 at each evaluation time point.
timeFrame: 24 weeks
measure: Percent change from baseline in pre-bronchodilator FEV1 at each evaluation time point.
timeFrame: 24 weeks
measure: Annualized rate of subjects experiencing severe asthma exacerbations.
timeFrame: 24 weeks
measure: Time to the first onset of the severe asthma exacerbation event.
timeFrame: 24 weeks
measure: Annualized rate of subjects experiencing the event of loss of asthma control (LOAC).
timeFrame: 24 weeks
measure: Time to the onset of the first event of LOAC.
timeFrame: 24 weeks
measure: FEV1 percentage of predicted value (FEV1% Pred)
timeFrame: 32 weeks
measure: Peak diurnal and nocturnal expiratory flow (PEF)
timeFrame: 32 weeks
measure: Forced vital capacity (FVC)
timeFrame: 32 weeks
measure: Maximal mid-expiratory flow (MMEF)
timeFrame: 32 weeks
measure: Change from baseline of FEV1 after the use of bronchodilator.
timeFrame: 32 weeks
measure: Change from baseline in the Asthma Control Questionnaire-5 (ACQ-5) score at each evaluation time point.
timeFrame: 32 weeks
measure: Change from baseline in asthma symptom score at each evaluation time point.
timeFrame: 32 weeks
measure: Incidence of Adverse events (AEs)
timeFrame: 32 weeks
measure: Trough concentration at steady-state of CM310
timeFrame: 32 weeks
measure: Human thymus and activation-regulated chemokine (TARC)
timeFrame: 32 weeks
measure: Fractional exhaled nitric oxide (FeNO).
timeFrame: 32 weeks
measure: Total IgE (immunoglobulin E)
timeFrame: 32 weeks
measure: Anti-drug antibodies (ADAs) and neutralizing antibodies (Nabs).
timeFrame: 32 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: China-Japan Friendship Hospital
Study officials:
References: