Recruiting
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.
ClinicalTrials.gov IDNCT07011524
PhasePHASE2
Enrollment200
SponsorKeymed Biosciences Co.Ltd
Age18 Years
SexALL
Conditions studied
Asthma
About this study
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.
Interventions
- Biological: CM512 injection — subcutaneous injection
- Drug: Placebo — subcutaneous injection
Primary outcomes
- Change from the baseline in Forced Expiratory Volume in one second (FEV1) (Up to week 12)
Eligibility information
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.
Study locations
- The First Clinical Hospital of Guangzhou Medical University, Guangzhou, Guangdong China
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.