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RecruitingPulmonary Disease, Chronic Obstructive

eValuating the Efficacy and Safety of InitiatinG depemokImab earLy therApy iN Chronic Obstructive Pulmonary Disorder (COPD) With Type 2 Inflammation

Eligible age

40–75 yrs

Accepts

All genders

Locations

1 state

Healthy volunteers

No

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About this study

Depemokimab is being developed as a treatment for individuals with moderate to severe Chronic Obstructive Pulmonary Disorder (COPD). The aim of this study is to assess the efficacy and safety of early initiation of depemokimab as an add-on medicine in participants with moderate to severe COPD with type 2 inflammation.

Sponsor: GlaxoSmithKline

You may qualify if…

  • ✓ Male or eligible female participants
  • ✓ Eosinophilic phenotype measured using Blood Eosinophil Count (BEC)
  • ✓ Moderate to severe COPD, defined as
  • ✓ A clinically documented history of COPD for at least 1 year
  • ✓ A post-salbutamol Forced expiratory volume in one second (FEV1)/Forced vital capacity (FVC) ratio of less than (\<)0.70 and a post-salbutamol FEV1 greater than (\>)30 percent (%) and \<80% predicted normal values
  • ✓ Elevated risk for exacerbations, defined as
  • ✓ A well-documented history of only 1 moderate COPD exacerbation in the prior 12 months and
  • ✓ The presence of risk factors for future exacerbations/deterioration such as:

You may not qualify if…

  • ✕ The Investigator must judge that COPD is the primary diagnosis accounting for the clinical manifestations of lung disease, and clinical manifestations of lung disease where primary diagnosis is not COPD are excluded
  • ✕ Participants with a current or prior physician diagnosis of asthma
  • ✕ Participants with childhood asthma are permitted, provided that childhood asthma has resolved before 18 years of age and has not recurred
  • ✕ Other clinically significant lung disease: The Investigator must judge that COPD is the primary diagnosis accounting for the clinical manifestations of the lung disease.
  • ✕ COPD severity: Participants with more than one moderate exacerbation or severe exacerbation in the past 12 months prior to Visit 1
  • ✕ COPD stability: Participants with pneumonia, COPD exacerbation, or lower respiratory tract infection within the 4 weeks prior to Visit 1
  • ✕ Lung resection: Participants with a history of, or plan for lung volume reduction surgery/endobronchial valve procedure
  • ✕ Pulmonary rehabilitation: Participants in the acute phase of a pulmonary rehabilitation program within 4 weeks prior to Visit 1

Where it's recruiting

Florida

Doral

Source: ClinicalTrials.gov · NCT07177339 · last updated 2025-11-25

eValuating the Efficacy and Safety of InitiatinG depemokImab earLy the · TrialPath