Status:
NOT_YET_RECRUITING
A Study of CM512 in Subjects With Moderate-to-Severe Chronic Obstructive Pulmonary Disease
Lead Sponsor:
Keymed Biosciences Co.Ltd
Conditions:
Chronic Obstructive Pulmonary Disease
Eligibility:
All Genders
40-80 years
Phase:
PHASE2
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 Dis...
Detailed Description
This is a Phase II, multicenter, randomized, double-blind, placebo-controlled, parallel group study to evaluate the safety and efficacy of CM512 in adults with moderate-to-severe chronic obstructive p...
Eligibility Criteria
Inclusion
- 40 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
- 2 moderate or ≥1 severe COPD exacerbations in the prior year
- CAT ≥10 at screening
- Former or current smokers ≥10 pack-years
Exclusion
- 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.
Key Trial Info
Start Date :
June 20 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 17 2028
Estimated Enrollment :
204 Patients enrolled
Trial Details
Trial ID
NCT06980142
Start Date
June 20 2025
End Date
March 17 2028
Last Update
May 20 2025
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