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NCT06959095 | RECRUITING | Pulmonary Disease, Chronic Obstructive

Depemokimab as an Extended treatmeNt Duration Biologic in Adults With Chronic Obstructive Pulmonary Disease (COPD) and Type 2 Inflammation (ENDURA -1)
Sponsor:

GlaxoSmithKline

Brief Summary:

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.

Condition or disease

Pulmonary Disease, Chronic Obstructive

Intervention/treatment

Depemokimab

Placebo

Phase

PHASE3

Study Type : INTERVENTIONAL
Estimated Enrollment : 981 participants
Masking : QUADRUPLE
Masking Description : This is a double-blind study neither the participants the caregivers the researchers nor the people assessing the outcomes know which treatment is being given to whom.
Primary Purpose : TREATMENT
Official Title : A Randomized, Double-Blind, Placebo- Controlled, Parallel-Group, Multicenter Study of the Efficacy and Safety of Depemokimab In Adult Participants With COPD With Type 2 Inflammation
Actual Study Start Date : 2025-06-20
Estimated Primary Completion Date : 2029-08-20
Estimated Study Completion Date : 2029-08-20

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 40 Years to 80 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • * 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.
  • * Participants should be on optimized inhaler therapy, defined as inhaled corticosteroid (ICS) plus Long-acting muscarinic receptor antagonist (LAMA) plus Long-acting beta2-adrenergic receptor agonist (LABA) either as multiple inhalers or a single combination inhaler for at least 6 months prior to Screening Visit 1.
  • * Body mass index (BMI) \>=16 kilogram per square meter (kg/m\^2).
  • * Male or eligible female participants.
Exclusion Criteria
  • 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
    • * Chronic hypercapnia requiring Non-invasive positive pressure ventilation (NIPPV) use (including Bi-Level Positive Airway Pressure \[BiPAP\] or Continuous Positive Airway Pressure \[CPAP\]).
    • * Unstable cardiovascular disease or arrhythmia.
    • * Parasitic Infection: Participants with a known, pre-existing parasitic infection within 6 months of Screening (Visit 1).
Depemokimab as an Extended treatmeNt Duration Biologic in Adults With Chronic Obstructive Pulmonary Disease (COPD) and Type 2 Inflammation (ENDURA -1)

Location Details

NCT06959095

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Florida

GSK Investigational Site

Miami, Florida, United States, 33155