A Study of CM512 in Subjects With Moderate-to-Severe Chronic Obstructive Pulmonary Disease
A Randomized, Double-blind, Placebo-controlled Phase II Clinical Study Evaluating CM512 Injection in Subjects With Moderate-to-Severe Chronic Obstructive Pulmonary Disease
1 other identifier
interventional
204
0 countries
N/A
Brief Summary
A Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase II Study to Explore the Efficacy and Safety of CM512 Injection in Adults with Moderate-to-Severe Chronic Obstructive Pulmonary Disease (COPD)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 chronic-obstructive-pulmonary-disease
Started Jun 2025
Typical duration for phase_2 chronic-obstructive-pulmonary-disease
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
May 12, 2025
CompletedFirst Posted
Study publicly available on registry
May 20, 2025
CompletedStudy Start
First participant enrolled
June 20, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 17, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 17, 2028
May 20, 2025
May 1, 2025
2.7 years
May 12, 2025
May 12, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Annualised rate of moderate or severe COPD exacerbations
The annualised moderate or severe COPD exacerbation rate (based on exacerbations reported by the investigator) up to 52 weeks treatment period compared to placebo.
Baseline up to 52 weeks
Study Arms (3)
Dose 1
EXPERIMENTALDose 2
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- to ≤ 80 years old
- BMI ≥ 18.0 kg/(m\*m)
- COPD diagnosis≥1 year
- Post-BD FEV1 ≥ 30% and \< 80%, FEV1/FVC \<0.70 at screening
- Triple (LABA+LAMA+ICS) or dual inhaled (LABA+LAMA or LABA+ICS) COPD therapy ≥3 months prior to V1
- moderate or ≥1 severe COPD exacerbations in the prior year
- CAT ≥10 at screening
- Former or current smokers ≥10 pack-years
You may not qualify if:
- Clinically important pulmonary disease other than COPD, as judged by the Investigator (including current or historic asthma diagnosis).
- Any disorder, including, but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, hematological, psychiatric, or major physical impairment that is not stable.
- Treatment with oxygen of more than 15 hours per day.
- Pregnant or breastfeeding.
- The chest/lungs with pathology that precludes the patient's ability to complete the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jinfu Xu
Huadong Hospital
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
May 12, 2025
First Posted
May 20, 2025
Study Start
June 20, 2025
Primary Completion (Estimated)
March 17, 2028
Study Completion (Estimated)
March 17, 2028
Last Updated
May 20, 2025
Record last verified: 2025-05