Phase 2 Trial Evaluating Galvokimig Injection Over 24 to 52 Weeks in Adults Aged 40 to 80 with Moderate-to-Severe COPD and Chronic Bronchitis

What this Trial Is About

Researchers are studying the effects of galvokimig compared to a placebo in adults aged 40 to 80 who have moderate-to-severe chronic obstructive pulmonary disease COPD with chronic bronchitis. The study aims to measure the time until the first acute exacerbation of COPD AECOPD in this group. This phase 2 trial seeks to understand how galvokimig may impact disease flare-ups and patient outcomes. Participants will be randomly assigned to one of three groups two different dose levels of galvokimig or a matching placebo, all given as injections. The treatment period lasts between 24 and 52 weeks. The study uses a quadruple-blind design, meaning neither participants nor the researchers know which treatment is given to ensure unbiased results. During the trial, participants will be monitored for lung function through tests like forced expiratory volume in 1 second FEV1, as well as assessed for respiratory symptoms using questionnaires such as the St. Georges Respiratory Questionnaire-COPD-specific version SGRQ-C. Researchers will record the rate and severity of COPD exacerbations and track any adverse events. The primary outcome focuses on the timing of the first moderate or severe AECOPD up to 60 weeks. Safety and quality of life are also evaluated throughout the study.

A Study of 24 to 52 Weeks Treatment to Evaluate The Efficacy And Safety of Galvokimig in Study Participants With Moderate-to-Severe Chronic Obstructive Pulmonary Disease (COPD) With Chronic Bronchitis