The purpose of this study is to assess the efficacy and safety of verekitug (UPB-101) in participants with moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD), an inflammatory lung disease.
This is a global, multicenter study to assess the efficacy, safety, and tolerability of verekitug in participants with moderate-to-severe COPD. Adult participants are planned to be enrolled and will be allocated randomly in a 1:1:1 ratio to one of two dose levels of verekitug or placebo, in addition to their COPD background medications. The study consists of a screening period of approximately 4 weeks; treatment periods of between 60 weeks and up to 108 weeks; and a follow-up period, with the end-of-study visit 16 weeks after last dose.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
666
Annualized rate of moderate or severe COPD exacerbation events
Time frame: From Day 1 (Baseline) up to Week 108
Change in pre-bronchodilator forced expiratory capacity in 1 second (FEV1)
Time frame: From Day 1 (Baseline) to Week 60
Annualized rate of severe COPD exacerbation events
Time frame: From Day 1 (Baseline) up to Week 108
Change in St. George's Respiratory Questionnaire (SGRQ) total score
Time frame: From Day 1 (Baseline) to Week 60
Proportion of participants with SGRQ improvement of >4 points
Time frame: At Week 60
Incidence of treatment-emergent adverse events and serious adverse events
Time frame: From Day 1 (Baseline) up to Week 112
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