Study of CM512 Injection in Subjects With Moderate-to-severe Asthma
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.
1 other identifier
interventional
200
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 asthma
Started Aug 2025
Typical duration for phase_2 asthma
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 5, 2025
CompletedFirst Posted
Study publicly available on registry
June 8, 2025
CompletedStudy Start
First participant enrolled
August 19, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 21, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 21, 2027
August 28, 2025
June 1, 2025
1.9 years
June 5, 2025
August 21, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Change from the baseline in Forced Expiratory Volume in one second (FEV1)
Change from baseline in pre-bronchodilator FEV1 in each dose group at 12 weeks of CM512 treatment compared with placebo.
Up to week 12
Study Arms (2)
Group 1
EXPERIMENTALGroup 2
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The First Clinical Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ruchong Chen
The First Clinical Hospital of Guangzhou Medical University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 5, 2025
First Posted
June 8, 2025
Study Start
August 19, 2025
Primary Completion (Estimated)
July 21, 2027
Study Completion (Estimated)
July 21, 2027
Last Updated
August 28, 2025
Record last verified: 2025-06