The study is a Phase II, multicenter, double-blind, randomized, parallel, placebo-controlled clinical trial designed to evaluate the efficacy, safety of 9MW1911 in patients with Chronic Obstructive Pulmonary Disease (COPD).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
360
Participants will receive IV 9MW1911 in each dose every 28 days.
Participants will receive IV placebo every 28 days.
The annualized incidence rate of moderate to severe acute exacerbations of chronic obstructive pulmonary disease (AECOPD) within 52 weeks
Within a 52-week period, the number of acute exacerbations of chronic obstructive pulmonary disease (AECOPD) is converted to an annual incidence rate.
Time frame: Baseline up to week 52
Changes from baseline in pre-bronchodilator FEV1
Changes in pre-bronchodilator FEV1 levels at 4, 8, 12, 24,36 and 52 weeks compared to baseline.
Time frame: Weeks 0, 4, 8, 12,24,36,52
Changes from baseline in post-bronchodilator FEV1
Changes in post-bronchodilator FEV1 levels at 4, 8, 12, 24,36and 52 weeks compared to baseline.
Time frame: Weeks 0, 4, 8, 12,24,36,52
Changes from baseline in pre-bronchodilator FVC
Changes in pre-brochodilator FVC levels at 4, 8, 12, 24,36 and 52 weeks compared to baseline.
Time frame: Weeks 0, 4, 8, 12,24,36,52
Changes from baseline in post-bronchodilator FVC
Changes in post-bronchodilator FVC levels at 4, 8, 12, 24,36 and 52 weeks compared to baseline.
Time frame: Weeks 0, 4, 8, 12,24,36,52
Time to first moderate to severe Chronic Obstructive Pulmonary Disease Acute Exacerbation (AECOPD) from baseline to week 52.
Time to first moderate to severe Chronic Obstructive Pulmonary Disease Acute Exacerbation (AECOPD) from baseline to week 52.
Time frame: Baseline to week 52
Annualized rate of moderate to severe AECOPD over the 52-week treatment period.
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Chizhou Central Hospital
Chizhou, Anhui, China
RECRUITINGAnhui Chest Hospital
Hefei, Anhui, China
RECRUITINGGansu Provincial People's Hospital
Lanzhou, Gansu, China
RECRUITINGHuizhou Third People's Hospital
Huizhou, Guangdong, China
RECRUITINGJiangmen Central Hospital
Jiangmen, Guangdong, China
RECRUITINGQingyuan Hospital Affiliated to Guangzhou Medical University
Qingyuan, Guangdong, China
RECRUITINGThe Affiliated Hospital of Zunyi Medical University
Zunyi, Guizhou, China
RECRUITINGHebei PetroChina Central Hospital
Langfang, Hebei, China
RECRUITINGThe First Affiliated Hospital of Nanyang Medical College
Nanyang, Henan, China
RECRUITINGThe First Affiliated Hospital of Xinxiang Medical University
Xinxiang, Henan, China
RECRUITING...and 41 more locations
Within a 52-week period, the number of severe acute exacerbations of chronic obstructive pulmonary disease (AECOPD) is converted to an annual incidence rate.
Time frame: Baseline to week 52
Time to first severe Chronic Obstructive Pulmonary Disease Acute Exacerbation (AECOPD) from baseline to week 52.
Time to first severe Chronic Obstructive Pulmonary Disease Acute Exacerbation (AECOPD) from baseline to week 52.
Time frame: Baseline up to week 52
The change from baseline in the St. George's Respiratory Questionnaire-COPD (SGRQ-C) total score
Changes in St. George's Respiratory Questionnaire-COPD (SGRQ-C) total score at 4, 12, 24,36 and 52 weeks compared to baseline.
Time frame: Weeks 0, 4, 12, 24,36,52
The proportion of subjects with a ≥4-point improvement from baseline in the total score of the St. George's Respiratory Questionnaire for COPD (SGRQ-C) at Weeks 4, 12, 24, 36, and 52
The proportion of subjects achieving improvement of ≥4 points from baseline in the St. George's Respiratory Questionnaire for COPD (SGRQ-C) total score at Weeks 4, 12, 24, 36, and 52.
Time frame: Weeks 0, 4, 12, 24,36,52
Changes from baseline in CAT(COPD Assessment Test) score at 4,12 ,24,36 and 52 weeks.
Changes in CAT score at 4,12,24,36 and 52 weeks compared to baseline.
Time frame: Weeks 0, 4, 12, 24,36,52
Safety and tolerability assessment
The incidence and severity of adverse events, adverse reactions, serious adverse events, as well as abnormal clinical laboratory test indicators, vital signs, physical examinations, and 12-lead electrocardiograms.
Time frame: 60 weeks
Immunogenicity Assessment
The incidence of Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (Nab).
Time frame: 52 weeks
serum concentrations of 9MW1911
Pharmacokinetics: concentrations of 9MW1911 in serum.
Time frame: 32 weeks
Biological Marker
Serum levels of IL-33, IL-5, IL-13, and total sST2, and phosphorylated P38 (p-P38) .
Time frame: 52 weeks
Pharmacogenomics Characteristics
Single nucleotide polymorphism of gene rs10206753
Time frame: week 0