A Study of CM310 in Subjects With Moderate to Severe Asthma

Keymed Biosciences

Status and phase: Completed; Phase 2

Conditions: Asthma

Treatments: Other: Placebo; Drug: CM310

Study type: Interventional

Funder types: Industry

Identifiers

NCT05186909

CM310-CSP-001

Details and patient eligibility

About

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.

Enrollment: 52 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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52 participants in 3 patient groups, including a placebo group

CM310 300mg Q2W

Experimental group

Description:

CM310 is injected subcutaneously (SC) with a loading dose of 600 mg at the first dose, and then 300 mg each time, once every 2 weeks (Q2W) for a total of 12 doses.

Treatment:

Drug: CM310

CM310 150mg Q2W

Experimental group

Description:

CM310 is injected subcutaneously (SC) with a loading dose of 300 mg at the first dose, and then 150 mg each time, once every 2 weeks (Q2W) for a total of 12 doses.

Treatment:

Drug: CM310

Placebo

Placebo Comparator group

Description:

Subcutaneous injection (SC), once every 2 weeks (Q2W) for a total of 12 doses.

Treatment:

Other: Placebo