🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in the UK / NCT07177339
Recruiting Phase 3

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

NCT07177339 · tracked via the Priya Life Science UK tracker
Sponsor
GlaxoSmithKline
Phase
Phase 3
Started
2025-10-20
Last updated
2026-07-28

Condition(s) studied

Pulmonary Disease, Chronic Obstructive

Investigational drug(s) / intervention(s)

DepemokimabPlacebo

Depemokimab: Depemokimab will be administered.

Placebo: Matching placebo will be administered.

Study summary

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.

Eligibility

Sex
ALL
Min age
40 Years
Max age
75 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (121)

FacilityCityRegionStatus
GSK Investigational Site Newport Beach California Recruiting
GSK Investigational Site Lakewood Colorado Recruiting
GSK Investigational Site Brandon Florida Recruiting
GSK Investigational Site Crystal River Florida Recruiting
GSK Investigational Site Doral Florida Recruiting
GSK Investigational Site Greenacres City Florida Recruiting
GSK Investigational Site Hialeah Florida Recruiting
GSK Investigational Site Hollywood Florida Recruiting
GSK Investigational Site Miami Florida Recruiting
GSK Investigational Site Miami Florida Recruiting
GSK Investigational Site Miami Florida Recruiting
GSK Investigational Site Miami Lakes Florida Recruiting
GSK Investigational Site Orlando Florida Recruiting
GSK Investigational Site Cordele Georgia Recruiting
GSK Investigational Site Dunwoody Georgia Recruiting
GSK Investigational Site Boise Idaho Recruiting
GSK Investigational Site Bowling Green Kentucky Recruiting
GSK Investigational Site Lake Charles Louisiana Recruiting
GSK Investigational Site Shreveport Louisiana Recruiting
GSK Investigational Site Bangor Maine Recruiting
GSK Investigational Site Allen Park Michigan Recruiting
GSK Investigational Site Clarkston Michigan Recruiting
GSK Investigational Site Dearborn Michigan Recruiting
GSK Investigational Site Henderson Nevada Recruiting
GSK Investigational Site Las Vegas Nevada Recruiting
GSK Investigational Site Reno Nevada Recruiting
GSK Investigational Site Winston-Salem North Carolina Recruiting
GSK Investigational Site Edmond Oklahoma Recruiting
GSK Investigational Site DuBois Pennsylvania Recruiting
GSK Investigational Site West Chester Pennsylvania Recruiting
GSK Investigational Site Greenville South Carolina Recruiting
GSK Investigational Site Rock Hill South Carolina Recruiting
GSK Investigational Site Knoxville Tennessee Recruiting
GSK Investigational Site Dallas Texas Recruiting
GSK Investigational Site DeSoto Texas Recruiting
GSK Investigational Site Greenville Texas Recruiting
GSK Investigational Site Houston Texas Recruiting
GSK Investigational Site Houston Texas Recruiting
GSK Investigational Site Houston Texas Recruiting
GSK Investigational Site Katy Texas Recruiting

+ 81 more sites — see the full list on the official registry below.

More GlaxoSmithKline trials in the UK

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07177339 on ClinicalTrials.gov ↗ ← All trials in the UK