Depemokimab for Moderate to Severe COPD with Type 2 Inflammation

This study is evaluating depemokimab, a potential new treatment for people with moderate to severe Chronic Obstructive Pulmonary Disorder (COPD). Researchers want to see how well depemokimab works and if it's safe when started early as an add-on medication for those with a specific type of inflammation called Type 2 inflammation. You might be able to join if you are between 40 and 75 years old, have moderate to severe COPD for at least a year, and have a certain level of eosinophils (a type of white blood cell) in your blood. The main goal is to see if depemokimab can reduce the number of moderate or severe COPD flare-ups you experience over about three years. The current status of this study is unclear, and it aims to enroll 1196 participants.

Study design
This interventional study will compare depemokimab to a placebo (an inactive substance) in about 1196 participants. The phase of the study is not specified.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will track the rate of moderate/severe exacerbations from when you start until up to Week 156 (about three years).

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

NCT07177339

eValuating the Efficacy and Safety of InitiatinG depemokImab earLy therApy iN Chronic Obstructive Pulmonary Disorder (COPD) With Type 2 Inflammation

Recruiting
PHASE3Ages 40–75InterventionalTreatment
GlaxoSmithKline
~1,196 participants
Updated 2026-07-28 on ClinicalTrials.gov
What's tested:DepemokimabPlacebo

At a glance

Recruiting sites
121 of 121 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 156
Pulmonary Disease, Chronic Obstructive
121 sites across 34 states
China40
Florida11
Texas9
Bulgaria6
Germany6
Michigan3
Nevada3
Sichuan3
  • GSK Clinical Trials · STUDY_DIRECTOR · GlaxoSmithKline
US GSK Clinical Trials Call Center
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Eligibility criteria

Inclusion

Male or eligible female participants
Eosinophilic phenotype measured using Blood Eosinophil Count (BEC)
Moderate to severe COPD, defined as
A clinically documented history of COPD for at least 1 year
A post-salbutamol Forced expiratory volume in one second (FEV1)/Forced vital capacity (FVC) ratio of less than (\<)0.70 and a post-salbutamol FEV1 greater than (\>)30 percent (%) and \<80% predicted normal values
Elevated risk for exacerbations, defined as
A well-documented history of only 1 moderate COPD exacerbation in the prior 12 months and
The presence of risk factors for future exacerbations/deterioration such as:
Modified Medical Research Council (mMRC) dyspnea score \>= 2
COPD Assessment Test (CAT) \>= 15
Post-bronchodilator FEV1 \< 50% predicted
Chronic bronchitis
Smoking status: Current or former cigarette smokers with a history of cigarette smoking of \>=10 pack-years at Screening.
Dual (Inhaled corticosteroid (ICS)+ Long-acting beta2-adrenergic receptor agonist \[LABA\] or LABA+ Long-acting muscarinic receptor antagonist \[LAMA\]) or triple (ICS+LABA+LAMA) inhaler therapy as assessed by the investigator for at least 3 months
Body mass index (BMI) \>=16 kilograms per square meter (kg/m\^2)

Exclusion

The Investigator must judge that COPD is the primary diagnosis accounting for the clinical manifestations of lung disease, and clinical manifestations of lung disease where primary diagnosis is not COPD are excluded
Participants with a current or prior physician diagnosis of asthma
Participants with childhood asthma are permitted, provided that childhood asthma has resolved before 18 years of age and has not recurred
Other clinically significant lung disease: The Investigator must judge that COPD is the primary diagnosis accounting for the clinical manifestations of the lung disease.
COPD severity: Participants with more than one moderate exacerbation or severe exacerbation in the past 12 months prior to Visit 1
COPD stability: Participants with pneumonia, COPD exacerbation, or lower respiratory tract infection within the 4 weeks prior to 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 Visit 1
Chronic hypercapnia requiring non-invasive positive pressure ventilation (NIPPV) use including Bi-Level Positive Airway Pressure (BiPAP) or Continuous Positive Airway Pressure (CPAP) are excluded
Continuous oxygen: Participants requiring oxygen supplementation for COPD
  • Annualized Rate of Moderate/Severe ExacerbationsFrom Baseline Up to Week 156

    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 (that is greater than or equal to \[\>=\] 24 hours) or result in death. The frequency of moderate/ severe exacerbations expressed as an annualized rate of moderate or severe exacerbations will be reported.