RecruitingPhase 3NCT07177339

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

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


Sponsor

GlaxoSmithKline

Enrollment

1,196 participants

Start Date

Oct 20, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 40 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study — called VIGILANT — is testing whether starting a biologic drug called depemokimab early improves outcomes for people with COPD (chronic obstructive pulmonary disease) who have a type of airway inflammation driven by immune cells called eosinophils (Type 2 inflammation). Depemokimab targets a protein called IL-5 to reduce these cells. **You may be eligible if...** - You have been diagnosed with moderate to severe COPD for at least 1 year - Your breathing test (spirometry) shows an FEV1/FVC ratio below 0.70 and FEV1 between 30-80% of what is normal for you - You have an elevated eosinophil (a type of immune cell) count in your blood - You have had at least 1 moderate COPD flare-up (exacerbation) in the past 12 months **You may NOT be eligible if...** - You have very severe COPD (FEV1 below 30%) - You do not have the eosinophilic (Type 2) type of COPD - You have not had any recent exacerbations - You have other health conditions that would interfere with the study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDepemokimab

Depemokimab will be administered.

DRUGPlacebo

Matching placebo will be administered.


Locations(6)

GSK Investigational Site

Doral, Florida, United States

GSK Investigational Site

Chengdu, China

GSK Investigational Site

Guilin, China

GSK Investigational Site

Jiangmen, China

GSK Investigational Site

Nanchang, China

GSK Investigational Site

Taizhou, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT07177339


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