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A Study of CM310 in Subjects With Moderate to Severe Chronic Obstructive Pulmonary Disease

StatusNot Yet Recruiting
PhasePhase 2/3
Started2024-09-13
View on ClinicalTrials.gov ↗

Amendment history

2024-08-11
Study Status, Study Description, Conditions v1
Study description+675 characters
The study has two parts. Each part consists of three periods, including an up to 4-week screening period, a 52-week randomized treatment period, and a 8-week safety follow-up period. During the first part, patients who meet eligibility criteria will be randomized 1:1:1 to receive either CM310 300 mg [...]
2024-08-07
Original filing
This study is a multi-center, randomized, double-blind, placebo-controlled Phase Ⅱ/Ⅲ clinical study to evaluate the efficacy, safety, PK characteristics, PD effects and immunogenicity of CM310 in subjects with moderate to severe Chronic Obstructive Pulmonary Disease（COPD）. The study has two parts. Each part consists of three periods, including an up to 4-week screening period, a 52-week randomized treatment period, and a 8-week safety follow-up period.
Trial Details
NCT Number NCT06547333
Lead Sponsor CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Conditions Chronic Obstructive Pulmonary Disease
Enrollment 884 participants
Start Date 2024-09-13
Primary Completion 2032-04-29 (estimated)
Study Completion 2032-10-31 (estimated)
Updated on ClinicalTrials.gov 2024-08-14