RecruitingPulmonary Disease, Chronic Obstructive
Depemokimab as an Extended treatmeNt Duration Biologic in Adults With Chronic Obstructive Pulmonary Disease (COPD) and Type 2 Inflammation (ENDURA -1)
Eligible age
40–80 yrs
Accepts
All genders
Locations
3 states
Healthy volunteers
No
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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 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 less than (\<) 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
Where it's recruiting
Source: ClinicalTrials.gov · NCT06959095 · last updated 2025-10-08