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

RecruitingPhase 3

A Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled Study of the Efficacy and Safety of Early Depemokimab Initiation as add-on Treatment in COPD Patients With Type 2 Inflammation

Who can join

Ages 40 to 75 · All sexes

Full eligibility criteria
Inclusion Criteria:

* 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 Criteria:

* 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

About the study

Depemokimab is being developed as a treatment for individuals with moderate to severe Chronic Obstructive Pulmonary Disorder (COPD). The aim of this study is to assess the efficacy and safety of early initiation of depemokimab as an add-on medicine in participants with moderate to severe COPD with type 2 inflammation.

What is being tested

Sponsor: GlaxoSmithKline · Participants: 1,196 · Started: Oct 20, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT07177339

Locations in the U.S.

CaliforniaGSK Investigational Site, Newport Beach
ColoradoGSK Investigational Site, Lakewood
FloridaGSK Investigational Site, Brandon
GSK Investigational Site, Crystal River
GSK Investigational Site, Doral
GSK Investigational Site, Greenacres City
GSK Investigational Site, Hialeah
GSK Investigational Site, Hollywood
GSK Investigational Site, Miami
GSK Investigational Site, Miami
GSK Investigational Site, Miami
GSK Investigational Site, Miami Lakes
GSK Investigational Site, Orlando
GeorgiaGSK Investigational Site, Cordele
GSK Investigational Site, Dunwoody
IdahoGSK Investigational Site, Boise
KentuckyGSK Investigational Site, Bowling Green
LouisianaGSK Investigational Site, Lake Charles
GSK Investigational Site, Shreveport
MaineGSK Investigational Site, Bangor
MichiganGSK Investigational Site, Allen Park
GSK Investigational Site, Clarkston
GSK Investigational Site, Dearborn
NevadaGSK Investigational Site, Henderson
GSK Investigational Site, Las Vegas
GSK Investigational Site, Reno
North CarolinaGSK Investigational Site, Winston-Salem
OklahomaGSK Investigational Site, Edmond
PennsylvaniaGSK Investigational Site, DuBois
GSK Investigational Site, West Chester
South CarolinaGSK Investigational Site, Greenville
GSK Investigational Site, Rock Hill
TennesseeGSK Investigational Site, Knoxville
TexasGSK Investigational Site, Dallas
GSK Investigational Site, DeSoto
GSK Investigational Site, Greenville
GSK Investigational Site, Houston
GSK Investigational Site, Houston
GSK Investigational Site, Houston
GSK Investigational Site, Katy
GSK Investigational Site, Mesquite
GSK Investigational Site, Stafford

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.