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Depemokimab for COPD with Type 2 Inflammation (ENDURA -1)

This study is testing an investigational medicine called depemokimab for adults with moderate to severe Chronic Obstructive Pulmonary Disease (COPD) and a specific type of inflammation called Type 2 inflammation. Depemokimab is being compared to a placebo (an inactive substance like saline solution) to see if it can reduce the number of moderate or severe COPD flare-ups (exacerbations). You might be able to join if you are between 40 and 80 years old, have moderate to severe COPD with frequent flare-ups, and have elevated blood eosinophil counts (a type of white blood cell). The main goal is to see how well depemokimab works over about two years to prevent these flare-ups. The current recruitment status for this study is unclear.

Study design
This is an interventional study with a planned enrollment of 981 participants. It is comparing depemokimab to a placebo.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 104 weeks (about two years) to measure the rate of moderate/severe exacerbations.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06959095

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

Recruiting
PHASE3Ages 40–80InterventionalTreatment
GlaxoSmithKline
~981 participants
Updated 2025-10-08 on ClinicalTrials.gov
What's tested:DepemokimabPlacebo

At a glance

Recruiting sites
15 of 15 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Annualized Rate of Moderate/Severe Exacerbations
Measured over From Baseline up to Week 104

Conditions

Pulmonary Disease, Chronic Obstructive

Explore related trials

Chronic Obstructive Pulmonary DiseaseBlood eosinophil count

Where it's being run

15 sites across 7 states
China8
Florida2
South Carolina1
Texas1
Hunan1
Sichuan1
Japan1

Study leadership

  • GSK Clinical Trials · STUDY_DIRECTOR · GlaxoSmithKline

Who to contact

US GSK Clinical Trials Call Center
[email protected]
877-379-3718
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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).

What this trial measures

  • Annualized Rate of Moderate/Severe ExacerbationsFrom Baseline up to Week 104

    Moderate exacerbations are defined as clinically significant exacerbations that require treatment with oral/systemic corticosteroids and/or antibiotics. Severe exacerbations are defined as clinically significant exacerbations that require in-patient hospitalization (i.e., greater than or equal to \[\>=\] 24 hours) or result in death. The frequency of moderate/ severe exacerbations expressed as an annualized exacerbation rate will be evaluated.