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NCT Number: NCT07011524

Study of CM512 Injection in Subjects With Moderate-to-severe Asthma

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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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The First Clinical Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Location status: Recruiting

Location contact

Ruchong Chen

CONTACT

[email protected]

13710723826

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CM512 injection

Biological

subcutaneous injection

Placebo

Drug

subcutaneous injection

Primary outcomes

  1. Change from the baseline in Forced Expiratory Volume in one second (FEV1)

    Time frame: Up to week 12

    Change from baseline in pre-bronchodilator FEV1 in each dose group at 12 weeks of CM512 treatment compared with placebo.

Study contacts

Contact information is provided by the study sponsor or research team.

Qian Jia

CONTACT

[email protected]

028-88610620

Sponsors and collaborators

Lead sponsor

Keymed Biosciences Co.Ltd

Industry

Registry information

Official study title

A Randomized, Double-blind, Placebo-controlled Phase II Clinical Study Evaluating the Efficacy and Safety of CM512 Injection in Subjects With Moderate-to-severe Asthma.

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jun 8, 2025
Registry last updated
Aug 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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