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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age40-80
SponsorGlaxoSmithKline

About this trial

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.

Eligibility criteria

Qualifiers

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)

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

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Depemokimab
  • Placebo

Treatment groups

960 Participants
are divided into 2 treatment groups

Sponsors and collaborators