Status:
COMPLETED
A Study of CM310 in Subjects With Moderate to Severe Asthma
Lead Sponsor:
Keymed Biosciences Co.Ltd
Conditions:
Asthma
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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 subje...
Eligibility Criteria
Inclusion
- 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
- 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.).
Key Trial Info
Start Date :
January 12 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 13 2023
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT05186909
Start Date
January 12 2022
End Date
September 13 2023
Last Update
February 28 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
China-Japan Friendship Hospital
Beijing, China