A Study of CM310 in Subjects With Moderate to Severe Asthma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-12

Study Completion Date

2023-09-13

Brief Summary

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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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Detailed Description

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Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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CM310 300mg Q2W

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.

Group Type EXPERIMENTAL

CM310

Intervention Type DRUG

CM310 Recombinant Humanized Monoclonal Antibody Injection

CM310 150mg Q2W

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.

Group Type EXPERIMENTAL

CM310

Intervention Type DRUG

CM310 Recombinant Humanized Monoclonal Antibody Injection

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo

Interventions

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CM310

CM310 Recombinant Humanized Monoclonal Antibody Injection

Intervention Type DRUG

Placebo

Intervention Type OTHER

Eligibility Criteria

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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.).

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No