A Study of CM512 in Subjects With Moderate-to-Severe Chronic Obstructive Pulmonary Disease
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age40-80
SponsorKeymed Biosciences Co.Ltd
About this trial
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)
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
CM512
Biological/VaccineAdministered SC
Placebo
DrugAdministered SC
Treatment groups
204 Participants
are divided into 3 treatment groupsGroup A: Dose 1Experimental treatment 1 intervention
Group B: Dose 2Experimental treatment 1 intervention
Group C: PlaceboPlacebo comparator 1 intervention
Trial outcomes
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.
Time frame
Baseline up to 52 weeksLocations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: