A Phase II Study of CM326 in Subjects With Moderate to Severe Chronic Obstructive Pulmonary Disease
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age40-85
SponsorCSPC ZhongQi Pharmaceutical Technology Co., Ltd.
About this trial
This study is a multi-center, randomized, double-blind, placebo-controlled Phase II clinical study to evaluate the efficacy, safety, PK characteristics, PD effects and immunogenicity of CM326 in subjects with moderate to Severe Chronic Obstructive Pulmonary Disease.
The study consists of a screening period of up to 4 weeks, a randomized treatment period of 24 to 52 weeks, and a 12-week safety follow-up period.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Understand the study and voluntarily sign the informed consent form.
Age ≥40 and ≤85 years old, male or female, at the time of signing the informed consent.
weight ≥40 kg.
Diagnosed with COPD for at least 12 months.
Disqualifiers
A current diagnosis of asthma or history of asthma according to the Global Initiative for Asthma (GINA) guidelines（asthma alone or asthma as the primary diagnosis, including but not limited to asthma with COPD）
Subjects with significant pulmonary disease other than COPD (e.g., sarcoidosis, interstitial lung disease, primary pulmonary hypertension, bronchiectasis, Churg-Strauss Syndrome, active tuberculosis or non-tuberculous mycobacterial infection, etc.), in the opinion of the investigator. Or other conditions that could lead to elevated eosinophils.
The presence of any severe and/or uncontrolled medical condition that in the judgment of the investigator would affect the evaluation of the drug, including but not limited to: severe neurological disease (eg, epilepsy, dementia, etc), history of severe mental disorder, major cardiovascular disease, diabetes mellitus poorly controlled by intensive treatment, QTcF interval prolongation（male >450 msec, female >470 msec）, or persistent arrhythmia.
History of malignancy.
Trial design
Design model
Parallel
Treatments tested in this trial
CM326 dose 1
Drugsubcutaneous injection
CM326 dose 2
Drugsubcutaneous injection
Placebo
Other interventionsubcutaneous injection
Treatment groups
318 Participants
are divided into 2 treatment groupsGroup A: CM326Experimental treatment 2 interventions
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Annualized Rate of Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Acute Exacerbations
Annualized rate of moderate or severe acute exacerbation of COPD (AECOPD) over the placebo-controlled treatment period.
Time frame
week 24-52Secondary outcomes
1
Change from baseline in pre-bronchodilator forced expiratory volume in 1 second (FEV1) at each evaluation time point
FEV1 is the volume of air exhaled in the first second of a forced expiration as measured by spirometer. Change from baseline in FEV1 taken before bronchodilator use will be reported.
Time frame
week 16-242
Change from baseline in pre-bronchodilator forced expiratory volume in 1 second (FEV1) at each evaluation time point
FEV1 is the volume of air exhaled in the first second of a forced expiration as measured by spirometer. Change from baseline in FEV1 taken before bronchodilator use will be reported.
Time frame
week 24-523
Change from baseline in post-bronchodilator forced expiratory volume in 1 second (FEV1) at each evaluation time point
FEV1 is the volume of air exhaled in the first second of a forced expiration as measured by spirometer. Change from baseline in FEV1 taken after bronchodilator use will be reported.
Time frame
week 24-524
Change from baseline in Pre-bronchodilator Forced vital capacity (FVC) at each evaluation time point
Change from baseline in forced vital capacity taken before bronchodilator use will be reported. FVC is measured by spirometer.
Time frame
week 24-52Sponsors and contacts
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Source ClinicalTrials.gov