A Study of CM310 in Subjects With Moderate to Severe Asthma

Keymed Biosciences Co.Ltd52 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Asthma

Interventions

CM310DRUG

CM310 Recombinant Humanized Monoclonal Antibody Injection

PlaceboOTHER

Placebo

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.).

Locations (1)

China-Japan Friendship Hospital

Beijing, China

Outcomes

Primary Outcomes

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.

Time frame: 12 weeks

Secondary Outcomes

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.

Time frame: 24 weeks

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

Time frame: 24 weeks

Annualized rate of subjects experiencing severe asthma exacerbations.

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

Time frame: 24 weeks

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

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

Time frame: 24 weeks

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.

Time frame: 24 weeks

Time to the onset of the first event of LOAC.

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

Data from ClinicalTrials.gov

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