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
Qualifiers
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
Treatments tested in this trial
- CM326 dose 1
- CM326 dose 2
- Placebo
Treatment groups
318 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov