Recruiting

Phase 3

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

Sponsor:

GlaxoSmithKline

Code:

NCT07177339

Conditions

Pulmonary Disease, Chronic Obstructive

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

Interventions

Depemokimab

Placebo

Study Details

Brief 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.

Conditions

Pulmonary Disease, Chronic Obstructive

Study ID

NCT07177339

Start date

Oct 20, 2025

Status verified date

Jul, 2026

Completion date

Jun 8, 2029

Anticipated

Primary completion date

Apr 30, 2029

Anticipated

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

1196 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Depemokimab

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

experimental: Placebo

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

Interventions

Depemokimab

Depemokimab will be administered.

Placebo

Matching placebo will be administered.

Primary outcome measure

Annualized Rate of Moderate/Severe Exacerbations [ Time Frame: From Baseline Up to Week 156 ]

Central Contacts and Locations

Central contacts

US GSK Clinical Trials Call Center

877-379-3718 GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Center

+44 (0) 20 89904466 GSKClinicalSupportHD@gsk.com

Locations

GSK Investigational Site

Recruiting

Newport Beach, California, United States, 92663

Contacts

US GSK Clinical Trials Call Center

877-379-3718 GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com

Principal Investigator:

Ryan Klein

GSK Investigational Site

Recruiting

Lakewood, Colorado, United States, 80228-1813

Contacts

US GSK Clinical Trials Call Center

877-379-3718 GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com

Principal Investigator:

Dominic Titone

GSK Investigational Site

Recruiting

Brandon, Florida, United States, 33511

Contacts

US GSK Clinical Trials Call Center

877-379-3718 GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com

Principal Investigator:

GERMAN ALVAREZ

GSK Investigational Site

Recruiting

Crystal River, Florida, United States, 34429

Contacts

US GSK Clinical Trials Call Center

877-379-3718 GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com

Principal Investigator:

Ranganatha Potu

GSK Investigational Site

Recruiting

Doral, Florida, United States, 33172

Contacts

US GSK Clinical Trials Call Center

877-379-3718 GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com

Principal Investigator:

Felipe Gascon-Rodon

GSK Investigational Site

Recruiting

Greenacres City, Florida, United States, 33467

Contacts

US GSK Clinical Trials Call Center

877-379-3718 GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com

Principal Investigator:

Jorge Calle Medina

GSK Investigational Site

Recruiting

Hialeah, Florida, United States, 33012

Contacts

US GSK Clinical Trials Call Center

877-379-3718 GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com

Principal Investigator:

Alberto Manzor

GSK Investigational Site

Recruiting

Hollywood, Florida, United States, 33024

Contacts

US GSK Clinical Trials Call Center

877-379-3718 GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com

Principal Investigator:

Natalia Hegedosh

GSK Investigational Site

Recruiting

Miami, Florida, United States, 33125

Contacts

US GSK Clinical Trials Call Center

877-379-3718 GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com

Principal Investigator:

Ibrahim Menendez-Perez

GSK Investigational Site

Recruiting

Miami, Florida, United States, 33126

Contacts

US GSK Clinical Trials Call Center

877-379-3718 GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com

Principal Investigator:

Anish Dhadwal

GSK Investigational Site

Recruiting

Miami, Florida, United States, 33176

Contacts

US GSK Clinical Trials Call Center

877-379-3718 GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com

Principal Investigator:

Ariel Ramirez Navarro

GSK Investigational Site

Recruiting

Miami Lakes, Florida, United States, 33016

Contacts

US GSK Clinical Trials Call Center

877-379-3718 GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com

Principal Investigator:

Maria Elena Ocasio

GSK Investigational Site

Recruiting

Orlando, Florida, United States, 32825

Contacts

US GSK Clinical Trials Call Center

877-379-3718 GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com

Principal Investigator:

Humberto Cruz

GSK Investigational Site

Recruiting

Cordele, Georgia, United States, 31015

Contacts

US GSK Clinical Trials Call Center

877-379-3718 GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com

Principal Investigator:

David Kavtaradze

GSK Investigational Site

Recruiting

Dunwoody, Georgia, United States, 30350

Contacts

US GSK Clinical Trials Call Center

877-379-3718 GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com

Principal Investigator:

Marie Walton

GSK Investigational Site

Recruiting

Boise, Idaho, United States, 83702

Contacts

US GSK Clinical Trials Call Center

877-379-3718 GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com

Principal Investigator:

Bill Laitinen

GSK Investigational Site

Recruiting

Bowling Green, Kentucky, United States, 42101

Contacts

US GSK Clinical Trials Call Center

877-379-3718 GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com

Principal Investigator:

George Bush

GSK Investigational Site

Recruiting

Lake Charles, Louisiana, United States, 70605

Contacts

US GSK Clinical Trials Call Center

877-379-3718 GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com

Principal Investigator:

Jason Langhofer

GSK Investigational Site

Recruiting

Shreveport, Louisiana, United States, 71105

Contacts

US GSK Clinical Trials Call Center

877-379-3718 GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com

Principal Investigator:

David Green

GSK Investigational Site

Recruiting

Bangor, Maine, United States, 04401

Contacts

US GSK Clinical Trials Call Center

877-379-3718 GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com

Principal Investigator:

Paul Shapero

GSK Investigational Site

Recruiting

Allen Park, Michigan, United States, 48101

Contacts

US GSK Clinical Trials Call Center

877-379-3718 GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com

Principal Investigator:

Syed Raza

GSK Investigational Site

Recruiting

Clarkston, Michigan, United States, 48346

Contacts

US GSK Clinical Trials Call Center

877-379-3718 GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com

Principal Investigator:

Dean Moscovic

GSK Investigational Site

Recruiting

Dearborn, Michigan, United States, 48126

Contacts

US GSK Clinical Trials Call Center

877-379-3718 GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com

Principal Investigator:

Abdulhassan Saad

GSK Investigational Site

Recruiting

Henderson, Nevada, United States, 89052

Contacts

US GSK Clinical Trials Call Center

877-379-3718 GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com

Principal Investigator:

Vikas Sayal

GSK Investigational Site

Recruiting

Las Vegas, Nevada, United States, 89123

Contacts

US GSK Clinical Trials Call Center

877-379-3718 GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com

Principal Investigator:

Vrijendra Hoon

GSK Investigational Site

Recruiting

Reno, Nevada, United States, 89502

Contacts

US GSK Clinical Trials Call Center

877-379-3718 GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com

Principal Investigator:

Farah Madhani-Lovely

GSK Investigational Site

Recruiting

Winston-Salem, North Carolina, United States, 27103

Contacts

US GSK Clinical Trials Call Center

877-379-3718 GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com

Principal Investigator:

Farhan Ahmed

GSK Investigational Site

Recruiting

Edmond, Oklahoma, United States, 73013

Contacts

US GSK Clinical Trials Call Center

877-379-3718 GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com

Principal Investigator:

Kyle Rickner

GSK Investigational Site

Recruiting

DuBois, Pennsylvania, United States, 15801

Contacts

US GSK Clinical Trials Call Center

877-379-3718 GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com

Principal Investigator:

Sandeep Bansal

GSK Investigational Site

Recruiting

West Chester, Pennsylvania, United States, 19380

Contacts

US GSK Clinical Trials Call Center

877-379-3718 GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com

Principal Investigator:

Omer Abdullah

GSK Investigational Site

Recruiting

Greenville, South Carolina, United States, 29607

Contacts

US GSK Clinical Trials Call Center

877-379-3718 GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com

Principal Investigator:

Eric Garcia-Torres

GSK Investigational Site

Recruiting

Rock Hill, South Carolina, United States, 29732

Contacts

US GSK Clinical Trials Call Center

877-379-3718 GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com

Principal Investigator:

Michael Denenberg

GSK Investigational Site

Recruiting

Knoxville, Tennessee, United States, 37919

Contacts

US GSK Clinical Trials Call Center

877-379-3718 GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com

Principal Investigator:

Jonathan McFarland

GSK Investigational Site

Recruiting

Dallas, Texas, United States, 75254

Contacts

US GSK Clinical Trials Call Center

877-379-3718 GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com

Principal Investigator:

Shakil Ahmed

GSK Investigational Site

Recruiting

DeSoto, Texas, United States, 75115

Contacts

US GSK Clinical Trials Call Center

877-379-3718 GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com

Principal Investigator:

Haresh Boghara

GSK Investigational Site

Recruiting

Greenville, Texas, United States, 75401

Contacts

US GSK Clinical Trials Call Center

877-379-3718 GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com

Principal Investigator:

Asif Aziz

GSK Investigational Site

Recruiting

Houston, Texas, United States, 77058

Contacts

US GSK Clinical Trials Call Center

877-379-3718 GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com

Principal Investigator:

Alfred Maksoud

GSK Investigational Site

Recruiting

Houston, Texas, United States, 77089

Contacts

US GSK Clinical Trials Call Center

877-379-3718 GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com

Principal Investigator:

Sandeep Gupta

GSK Investigational Site

Recruiting

Houston, Texas, United States, 77090

Contacts

US GSK Clinical Trials Call Center

877-379-3718 GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com

Principal Investigator:

Mohammad Siddiqui

GSK Investigational Site

Recruiting

Katy, Texas, United States, 77494

Contacts

US GSK Clinical Trials Call Center

877-379-3718 GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com

Principal Investigator:

Syed Ahmed

GSK Investigational Site

Recruiting

Mesquite, Texas, United States, 75149

Contacts

US GSK Clinical Trials Call Center

877-379-3718 GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com

Principal Investigator:

Samer Nachawati

GSK Investigational Site

Recruiting

Stafford, Texas, United States, 77477

Contacts

US GSK Clinical Trials Call Center

877-379-3718 GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com

Principal Investigator:

Sayyed Farhan Ali Jaffri

GSK Investigational Site

Recruiting

Kingston, Ontario, Canada, K7M 7E4

Contacts

US GSK Clinical Trials Call Center

877-379-3718 GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com

Principal Investigator:

Craig McGann

GSK Investigational Site

Recruiting

Windsor, Ontario, Canada, N8X 1T3

Contacts

US GSK Clinical Trials Call Center

877-379-3718 GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com

Principal Investigator:

Syed Anees

More Information

Sponsor

GlaxoSmithKline

Last update posted

Jul 28, 2026

Last verified

Jul, 2026

Keywords

Depemokimab
Chronic Obstructive Pulmonary Disorder
COPD
Type 2 inflammation
Eosinophilic phenotype
Exacerbation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-27. This information was provided to ClinicalTrials.gov by GlaxoSmithKline on 2026-07-28. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.