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.
Inclusion criteria:
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 has a documented record of receiving maintenance inhaled therapy at a stable dose for ≥3 months prior to Screening comprised of:
• long-acting beta2 agonist (LABA) +long-acting muscarinic antagonist (LAMA) ±inhaled corticosteroid (ICS)
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
Participant has acceptable inhaler and spirometry techniques according to American Thoracic Society/European Respiratory Society (ATS/ERS) guidelines during the Screening Visit
Participant can be male or female.
A male participant must agree to use contraception during the Intervention Periods and for at least 60 days after the final dose of study intervention and refrain from donating sperm during this period
A female participant is eligible to participate if she is not pregnant not breastfeeding, and at least one of the following conditions applies:
Participant is a current or ex-smoker (with tobacco smoking history of ≥10 pack-years)
Exclusion criteria:
ucbcares@ucb.com1-844-599-2273 (USA)
Participants randomly assigned to this arm will receive a predefined Galvokimig Dose.
Participants randomly assigned to this arm will receive a predefined Galvokimig Dose.
Participants randomly assigned to this arm will receive a matching Placebo.
ucbcares@ucb.com0018445992273
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