Hong He Ha Ni Zu Yi Zu Zi Zhi Zhou

Researchers are evaluating lunsekimig, a subcutaneous injection, compared with placebo in adults aged 40 to 80 years with inadequately controlled Chronic Obstructive Pulmonary Disease COPD characterized by an eosinophilic phenotype. This Phase 2bPhase 3 parallel study aims to assess the efficacy, safety, and tolerability of lunsekimig in reducing COPD exacerbations and improving lung function and symptoms. Participants are randomly assigned to one of three groups lunsekimig dose regimen A, lunsekimig dose regimen B, or a matching placebo. They will receive subcutaneous injections during a 48-week treatment period. The study also includes a screening period of up to 4 weeks before treatment and an approximately 8-week follow-up period after treatment, totaling up to 60 weeks of participation. During the study, participants will undergo regular assessments including lung function tests such as post- and pre-bronchodilator Forced Expiratory Volume in 1 second FEV1, questionnaires measuring respiratory health and symptoms, and monitoring of COPD exacerbations. Safety will be evaluated through reported adverse events and laboratory tests. Researchers will also monitor blood levels of lunsekimig and the presence of antidrug antibodies. Participants will be followed closely throughout the study duration to assess treatment impact and safety.