Recruiting

VIGILANTDepemokimab for COPD with Type 2 Inflammation

What is being tested

Depemokimab

+ Placebo

Drug

Who is being recruted

Chronic Disease+5

+ Lung Diseases

+ Lung Diseases, Obstructive

From 40 to 75 Years

+15 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 3

Interventional

Study Start: October 2025

See protocol details

Summary

Principal SponsorGlaxoSmithKline

Study ContactUS GSK Clinical Trials Call CenterMore contacts

Last updated: December 11, 2025

Sourced from a government-validated database.Claim as a partner

Study start date: October 20, 2025

Actual date on which the first participant was enrolled.

This study focuses on evaluating the effectiveness and safety of a medication called depemokimab for people who have moderate to severe Chronic Obstructive Pulmonary Disease (COPD) with type 2 inflammation. The goal is to see if starting this medicine early can help improve the symptoms and overall health of those affected by this condition. COPD is a long-term lung disease that makes it hard to breathe, and type 2 inflammation is a specific kind of inflammation that can occur in the lungs. By understanding how depemokimab works for these patients, researchers aim to improve treatment options and provide better care for those struggling with this challenging lung disease. Participants in the study will be randomly assigned to receive either depemokimab or a placebo, which is a substance with no active medication, to compare the outcomes. The medication is given as an add-on treatment, meaning it is used alongside the participants' usual COPD treatments. The study is designed to carefully monitor the participants' response to the treatment, looking at improvements in breathing, overall health, and any side effects that may occur. By measuring these factors, the study aims to determine if depemokimab can be a safe and effective option for managing COPD with type 2 inflammation.

Official TitleA 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

NCT07177339

Principal SponsorGlaxoSmithKline

Study ContactUS GSK Clinical Trials Call CenterMore contacts

Last updated: December 11, 2025

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

1196 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 40 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Chronic DiseaseLung DiseasesLung Diseases, ObstructivePathologic ProcessesRespiratory Tract DiseasesPathological Conditions, Signs and SymptomsDisease AttributesPulmonary Disease, Chronic Obstructive

Criteria

7 inclusion criteria required to participate

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

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8 exclusion criteria prevent from participating

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

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

Participants with Chronic Obstructive Pulmonary Disorder (COPD) with Type 2 inflammation will receive Depemokimab in combination with existing Standard of Care (SoC).

Group II

Experimental

Participants with COPD with Type 2 inflammation will receive matching Placebo in combination with existing SoC.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 6 locations

Recruiting

GSK Investigational Site

Doral, United StatesSee the location

Recruiting

GSK Investigational Site

Chengdu, China

Recruiting

GSK Investigational Site

Guilin, China

Recruiting

GSK Investigational Site

Jiangmen, China

Recruiting

6 Study Centers