Depemokimab is being developed as a treatment for individuals with moderate to severe COPD. The aim of this study is to assess the efficacy and safety of depemokimab compared as an add-on medicine in participants with uncontrolled moderate to severe COPD with type 2 inflammation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
960
Depemokimab as a sterile liquid formulation will be administered.
Placebo as a sterile 0.9 percent (%) sodium chloride solution will be administered
Annualized Rate of Moderate/Severe Exacerbations
Moderate exacerbations are defined as clinically significant exacerbations that require treatment with oral/systemic corticosteroids and/or antibiotics. Severe exacerbations are defined as clinically significant exacerbations that require in-patient hospitalization (i.e., greater than or equal to \[\>=\] 24 hours) or result in death. The frequency of moderate/ severe exacerbations expressed as an annualized exacerbation rate will be evaluated.
Time frame: From Baseline up to Week 104
Time to First Moderate/Severe Exacerbation
Moderate exacerbations are defined as clinically significant exacerbations that require treatment with oral/systemic corticosteroids and/or antibiotics. Severe exacerbations are defined as clinically significant exacerbations that require in-patient hospitalization (i.e., greater than or equal to \[\>=\] 24 hours) or result in death.
Time frame: From Baseline up to Week 104
Change from Baseline in St. George's Respiratory Questionnaire (SGRQ) Total Score at Week 52
The SGRQ total score will be measured using the SGRQ for COPD \[SGRQ-C\]. The SGRQ-C is a 40-item participant questionnaire designed to measure health impairment by addressing the frequency of respiratory symptoms (questions 1-7) and the participant's current state (questions 8-14). The questions are designed to be self-completed by the participant. The total score will be calculated on 0-100 rating scale and scores expressed as a percentage of overall impairment. Higher scores indicate greater impairment of health.
Time frame: From Baseline up to Week 52
Change from Baseline in Evaluating Respiratory Symptoms in Chronic Obstructive Pulmonary Disease (E-RS: COPD) Total Score at Week 52
E-RS: COPD consists of 11 items from the 14-item Exacerbations of Chronic Pulmonary Disease Tool - Patient Reported Outcomes (EXACT) instrument. E-RS: COPD is intended to capture information related to the respiratory symptoms of COPD, i.e., breathlessness, cough, sputum production, chest congestion, and chest tightness. The E-RS: COPD has a scoring range of 0 to 40, higher scores indicate more severe symptoms.
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GSK Investigational Site
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Aurora, Colorado, United States
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Brooksville, Florida, United States
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Doral, Florida, United States
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Fort Lauderdale, Florida, United States
RECRUITINGGSK Investigational Site
Miami, Florida, United States
RECRUITINGGSK Investigational Site
Miami, Florida, United States
RECRUITINGGSK Investigational Site
Miami, Florida, United States
RECRUITINGGSK Investigational Site
Miami, Florida, United States
RECRUITINGGSK Investigational Site
Miami, Florida, United States
RECRUITING...and 149 more locations
Time frame: From Baseline up to Week 52
Annualized Rate of Exacerbations Requiring Emergency Department (ED) Visit or Hospitalization
Annualized rate of exacerbations requiring ED Visit or Hospitalization (For pooled analysis across studies 222714 and 222725) will be assessed.
Time frame: From Baseline up to Week 104
Annualized Rate of Severe Exacerbations
Severe exacerbations are defined as clinically significant exacerbations that require in-patient hospitalization (i.e., greater than or equal to \[\>=\] 24 hours) or result in death. Annualized rate of severe exacerbations (For pooled analysis across studies 222714 and 222725) will be assessed.
Time frame: From Baseline up to Week 104