RecruitingPulmonary Disease, Chronic Obstructive

Depemokimab as an Extended treatmeNt Duration Biologic in Adults With Chronic Obstructive Pulmonary Disease (COPD) and Type 2 Inflammation (ENDURA-2)

Eligible age

40–80 yrs

Accepts

All genders

Locations

19 states

Healthy volunteers

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About this study

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.

Sponsor: GlaxoSmithKline

You may qualify if…

✓ Participants must be greater than or equal to (\>=) 40 to less than or equal to (\<=) 80 years of age, at the time of signing the Informed consent
✓ Elevated Blood Eosinophil Count (BEC)
✓ Moderate to severe COPD with frequent exacerbations, defined as:
✓ A clinically documented history of COPD as defined by the American Thoracic Society/European Respiratory Society for at least 1 year
✓ A post-bronchodilator forced expiratory volume in one second (FEV1)/ forced vital capacity (FVC) ratio of \< 0.70 and a post-bronchodilator FEV1 \>30 percent (%) and \<= 80% predicted normal values
✓ A well-documented history of at least 2 moderate or 1 severe exacerbation in the 12 months prior to screening
✓ COPD assessment test (CAT) score \>=10 at Visit 1
✓ Smoking status: Current or former cigarette smokers with a history of cigarette smoking of \>=10 pack-years.

You may not qualify if…

✕ The following subjects are excluded:
✕ Participants with a current or prior physician diagnosis of asthma
✕ Other clinically significant lung disease: The Investigator must judge that COPD is the primary diagnosis accounting for the clinical manifestations of the lung disease
✕ Participants with pneumonia, COPD exacerbation, or lower respiratory tract infection within the 4 weeks prior to Screening 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 Screening Visit 1
✕ Continuous oxygen: Participants requiring oxygen supplementation for more than 12 hours per day
✕ Cor pulmonale - resulting in right heart failure, severe pulmonary hypertension