About this trial
The purpose of the study is to investigate the efficacy of galvokimig versus placebo in the time to the first acute exacerbation of chronic obstructive pulmonary disease (AECOPD) in study participants with moderate-to-severe COPD with chronic bronchitis.
Eligibility criteria
Qualifiers
Participant must be aged ≥40 to ≤80 years of age, inclusive, at the time of signing the Informed Consent form (ICF)
Participant with a documented physician-diagnosed moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD) with chronic bronchitis phenotype
Participant at a high risk of exacerbations, defined as a documented exacerbation history of ≥2 moderate or severe acute exacerbation(s) of chronic obstructive pulmonary disease (AECOPD) in the 12 months prior to Screening or 1 severe AECOPD in the 6 months prior to Screening
Participant has a Chronic Airways Assessment Test (CAAT) score of ≥15 at Screening
Disqualifiers
Participant has any history or presence of any medical or psychiatric condition, physical examination finding, laboratory test result, or electrocardiogram (ECG) signal that, in the opinion of the investigator, could constitute a risk when taking the study intervention; or interfere with the interpretation of data and could jeopardize or would compromise the study participant's ability to participate in this study
Participant has a history of uncompensated heart failure, fluid overload, or myocardial infarction, or evidence of new onset ischemic heart disease or in the opinion of the investigator other serious cardiac disease, within 12 months prior to Screening
Participant has a presence or a family history (first degree) of inflammatory bowel disease (IBD)
Participant has uncontrolled neuropsychiatric disorder, active suicidal ideation, or positive suicidal behavior
Trial design
Treatments tested in this trial
- Galvokimig
- Placebo