Study of CM512 Injection 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

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-19

Study Completion Date

2027-07-21

Brief Summary

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This study is a multicenter, randomized, double-blind, placebo-controlled phase II clinical trial evaluating the efficacy, safety, pharmacokinetics, pharmacodynamics, and immunogenicity of CM512 in subjects with moderate-to-severe asthma.

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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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Group 1

Group Type EXPERIMENTAL

CM512 injection

Intervention Type BIOLOGICAL

subcutaneous injection

Group 2

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

subcutaneous injection

Interventions

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CM512 injection

subcutaneous injection

Intervention Type BIOLOGICAL

Placebo

subcutaneous injection

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Able to understand and comply with procedures of the protocol, and voluntarily sign the Informed Consent Form.
* Age ≥ 18 years old and ≤ 75 years old.
* Body mass index (BMI) ≥ 18.0 kg/(m\*m).
* Documented treatment with medium to high dose Inhaled Corticosteroids (ICS) in combination with asthma controller medication for at least 3 months with a stable dose ≥1 month prior to Visit 1.
* Documented history of at least 1 severe asthma exacerbation events within 12 months, and at least one of the exacerbations should occur during the treatment of medium-to-high dose ICS.
* Asthma Control Questionnaire-6 (ACQ-6) score ≥1.5

Exclusion Criteria

* Women of childbearing potential have a positive pregnancy test result during the screening period; women who are pregnant or lactating.
* With a history of drug abuse within the past 5 years before screening visit.
* Allergic or intolerant to CM512 injection or placebo components, or with a history of severe drug allergies or anaphylactic shock.
* With any medical or non-medical conditions that are not suitable for participation in this study by investigators.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No