Phase II Study of Intravenous 9MW1911 for Treatment of Chronic Obstructive Pulmonary Disease COPD in Adults Aged 40 to 75

What this Trial Is About

Researchers are evaluating 9MW1911 in adults aged 40 to 75 who have been diagnosed with Chronic Obstructive Pulmonary Disease COPD for at least one year. This Phase II clinical trial is designed to assess how well 9MW1911 works and how safe it is for treating COPD. The study compares two different doses of 9MW1911 given intravenously with a placebo, and aims to better understand treatment effects on COPD flare-ups and lung function. Participants receive intravenous infusions of either 9MW1911 in one of two dose levels or a placebo every 28 days. Each treatment group includes 120 patients, all receiving stable standard care for COPD. The study lasts for 52 weeks of treatment, followed by safety and immune response monitoring up to 60 weeks. Researchers measure lung function, COPD exacerbations, quality of life, and other health markers during this period. During the study, participants will have regular visits for lung function tests, questionnaires about COPD symptoms and quality of life, blood tests, and safety assessments. These assessments occur at multiple time points, such as weeks 0, 4, 8, 12, 24, 36, and 52. The main outcome is the rate of moderate to severe COPD exacerbations over one year. Additional measures include lung function changes, time to first exacerbation, and biological markers. Safety and tolerability are followed for up to 60 weeks to ensure participant well-being throughout the trial.

A Study to Evaluate 9MW1911 in Patients With Chronic Obstructive Pulmonary Disease (COPD)