Recruiting
Phase 3

Depemokimab

Sponsor:

GlaxoSmithKline

Code:

NCT06959095

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 COPD. The aim of this study is to assess the efficacy and safety of depemokimab as an add-on medicine in participants with uncontrolled moderate to severe COPD with type 2 inflammation.

Conditions

Pulmonary Disease, Chronic Obstructive

Study ID

NCT06959095

Start date

Jun 20, 2025

Status verified date

Sep, 2026

Completion date

Feb 14, 2029

Anticipated

Primary completion date

Dec 13, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Participants must be greater than or equal to (>=) 40 to less than or equal to (<=) 80 years of age, at the time of signing the informed consent
  • Elevated blood eosinophil count (BEC).
  • Moderate to severe COPD with frequent exacerbations, defined as:

  • A clinically documented history of COPD as defined by the American Thoracic Society/European Respiratory Society for at least 1 year
  • A post-bronchodilator forced expiratory volume in one second (FEV1)/forced vital capacity (FVC) ratio of less than (<) 0.70 and a post- bronchodilator FEV1 >30 percent (%) and <= 80% predicted normal values
  • A well-documented history of at least 2 moderate or 1 severe exacerbation in the 12 months prior to screening
  • COPD assessment test (CAT) score >=10 at Visit 1
  • Smoking status: Current or former cigarette smokers with a history of cigarette smoking of >=10 pack-years.
  • Participants should be on optimized inhaler therapy, defined as inhaled corticosteroid (ICS) plus Long-acting muscarinic receptor antagonist (LAMA) plus Long-acting beta2-adrenergic receptor agonist (LABA) either as multiple inhalers or a single combination inhaler for at least 6 months prior to Screening Visit 1
  • Body mass index (BMI) >=16 kilogram per square meter (kg/m\^2).
  • Male or eligible female participants

Exclusion Criteria:

The following subjects are excluded:

  • Participants with a current or prior physician diagnosis of asthma
  • Other clinically significant lung disease: The Investigator must judge that COPD is the primary diagnosis accounting for the clinical manifestations of the lung disease
  • Participants with pneumonia, COPD exacerbation, or lower respiratory tract infection within the 4 weeks prior to Screening 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 Screening Visit 1.
  • Continuous oxygen: Participants requiring oxygen supplementation for more than 16 hours per day to maintain resting oxygen saturation greater than 88%
  • Cor pulmonale - resulting in right heart failure, severe pulmonary hypertension
  • Chronic hypercapnia requiring Non-invasive positive pressure ventilation (NIPPV) use (including Bi-Level Positive Airway Pressure \[BiPAP\] or Continuous Positive Airway Pressure \[CPAP\])
  • Unstable cardiovascular disease or arrhythmia.
  • Parasitic Infection: Participants with a known, pre-existing parasitic infection within 6 months of Screening (Visit 1)

Study Design

Enrollment

981 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Depemokimab

Participants will be administered depemokimab along with standard of care (SoC).

placebo comparator: Placebo

Participants will be administered placebo along with SoC.

Interventions

Depemokimab

Depemokimab as a sterile liquid formulation will be administered.

Placebo

Placebo as a sterile 0.9 percent (%) sodium chloride solution will be administered.

Primary outcome measure

  • Annualized Rate of Moderate/Severe Exacerbations [ Time Frame: From Baseline up to Week 104 ]

Central Contacts and Locations

Central contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Center

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

Locations

GSK Investigational Site

Recruiting

Bakersfield, California, United States, 93301

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

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

Principal Investigator:

Tonny Tanus

GSK Investigational Site

Recruiting

Modesto, California, United States, 95355-4046

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

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

Principal Investigator:

Jose Rodriguez

GSK Investigational Site

Recruiting

Newport Beach, California, United States, 92663

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

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

Principal Investigator:

Ryan Klein

GSK Investigational Site

Recruiting

Wilmington, Delaware, United States, 19803

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

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

Principal Investigator:

Carole Guy

GSK Investigational Site

Recruiting

Bradenton, Florida, United States, 34209

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

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

Principal Investigator:

Patrick Weston

GSK Investigational Site

Recruiting

Brandon, Florida, United States, 33511-5706

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

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

Principal Investigator:

Rafael Martinez

GSK Investigational Site

Recruiting

Hialeah, Florida, United States, 33012

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

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

Principal Investigator:

Alberto Manzor

GSK Investigational Site

Recruiting

Hialeah, Florida, United States, 33016

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

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

Principal Investigator:

Juan Fernandez

GSK Investigational Site

Recruiting

Loxahatchee Groves, Florida, United States, 33470

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

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

Principal Investigator:

Neal Warshoff

GSK Investigational Site

Recruiting

Miami, Florida, United States, 33126

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

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

Principal Investigator:

Anish Dhadwal

GSK Investigational Site

Recruiting

Miami, Florida, United States, 33155

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

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

Principal Investigator:

Guillermo Somodevilla

GSK Investigational Site

Recruiting

Miami Lakes, Florida, United States, 33016

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

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

Principal Investigator:

Maria Elena Ocasio

GSK Investigational Site

Recruiting

Orange City, Florida, United States, 32763

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

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

Principal Investigator:

Kristyna Paradis

GSK Investigational Site

Recruiting

Palm Springs, Florida, United States, 33406

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

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

Principal Investigator:

Luis Castillo Hernandez

GSK Investigational Site

Recruiting

Palmetto Bay, Florida, United States, 33176-7296

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

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

Principal Investigator:

Michael Feldman

GSK Investigational Site

Recruiting

Pensacola, Florida, United States, 32503-2698

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

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

Principal Investigator:

Peter Bercz

GSK Investigational Site

Recruiting

Tamarac, Florida, United States, 33321

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

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

Principal Investigator:

Neena Chandrasekaran

GSK Investigational Site

Recruiting

Tampa, Florida, United States, 33614

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

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

Principal Investigator:

GERMAN ALVAREZ

GSK Investigational Site

Recruiting

The Villages, Florida, United States, 32162

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

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

Principal Investigator:

Angela Okolie

GSK Investigational Site

Recruiting

Riverdale, Georgia, United States, 30274

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

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

Principal Investigator:

Deon Miller

GSK Investigational Site

Recruiting

Stonecrest, Georgia, United States, 30038

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

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

Principal Investigator:

Rabahuddin Syed

GSK Investigational Site

Recruiting

Chicago, Illinois, United States, 60611

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

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

Principal Investigator:

Daniel Meza

GSK Investigational Site

Recruiting

Baltimore, Maryland, United States, 21224

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

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

Principal Investigator:

Sarath Raju

GSK Investigational Site

Recruiting

Clarkston, Michigan, United States, 48346

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

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

Principal Investigator:

Dean Moscovic

GSK Investigational Site

Recruiting

Flint, Michigan, United States, 48504-4730

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

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

Principal Investigator:

Ahmed Arif

GSK Investigational Site

Recruiting

St Louis, Missouri, United States, 63110

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

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

Principal Investigator:

Kaharu Sumino

GSK Investigational Site

Recruiting

Henderson, Nevada, United States, 89052-5015

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

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

Principal Investigator:

Vikas Sayal

GSK Investigational Site

Recruiting

Las Vegas, Nevada, United States, 89123-2874

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

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

Principal Investigator:

Vrijendra Hoon

GSK Investigational Site

Recruiting

Reno, Nevada, United States, 89502

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

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

Principal Investigator:

Farah Madhani-Lovely

GSK Investigational Site

Recruiting

North Massapequa, New York, United States, 11758

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

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

Principal Investigator:

Michael DiGiovanna

GSK Investigational Site

Recruiting

Winston-Salem, North Carolina, United States, 27103

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

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

Principal Investigator:

Farhan Ahmed

GSK Investigational Site

Recruiting

Winston-Salem, North Carolina, United States, 27104

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

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

Principal Investigator:

Jessica Bon

GSK Investigational Site

Recruiting

Greenville, South Carolina, United States, 29607

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@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

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

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

Principal Investigator:

Michael Denenberg

GSK Investigational Site

Recruiting

Franklin, Tennessee, United States, 37067

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

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

Principal Investigator:

Aaron Milstone

GSK Investigational Site

Recruiting

Corsicana, Texas, United States, 75110

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

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

Principal Investigator:

John Updegrove

GSK Investigational Site

Recruiting

Dallas, Texas, United States, 75234

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

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

Principal Investigator:

Chaitanya Tatineni

GSK Investigational Site

Recruiting

Houston, Texas, United States, 77058-2805

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

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

Principal Investigator:

Alfred Maksoud

GSK Investigational Site

Recruiting

Houston, Texas, United States, 77084

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

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

Principal Investigator:

Ajay Jain

GSK Investigational Site

Recruiting

Houston, Texas, United States, 77089

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

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

Principal Investigator:

Sandeep Gupta

GSK Investigational Site

Recruiting

McKinney, Texas, United States, 75069

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

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

Principal Investigator:

Shahrukh Kureishy

GSK Investigational Site

Recruiting

Pearland, Texas, United States, 77584

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

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

Principal Investigator:

Mohammad Siddiqui

GSK Investigational Site

Recruiting

Richmond, British Columbia, Canada, V6V 2L1

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

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

Principal Investigator:

Alexandra Lucas

GSK Investigational Site

Recruiting

Ajax, Ontario, Canada, L1S 2J5

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

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

Principal Investigator:

George Philteos

GSK Investigational Site

Recruiting

Toronto, Ontario, Canada, M5T 3A9

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

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

Principal Investigator:

Kenneth Chapman

GSK Investigational Site

Recruiting

Windsor, Ontario, Canada, N8X 1T3

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

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

Principal Investigator:

Syed Anees

GSK Investigational Site

Recruiting

Saint-Charles-Borromée, Quebec, Canada, J6E 2B4

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

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

Principal Investigator:

Bonavuth Pek

GSK Investigational Site

Recruiting

Sherbrooke, Quebec, Canada, J1L 0H8

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

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

Principal Investigator:

Philippe Lachapelle

GSK Investigational Site

Recruiting

Saskatoon, Saskatchewan, Canada, S7N 0W8

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

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

Principal Investigator:

Darcy Marciniuk

More Information

Sponsor

GlaxoSmithKline

Last update posted

Oct 5, 2026

Last verified

Sep, 2026

Keywords

  • Depemokimab
  • GSK3511294
  • Eosinophilic phenotype
  • Chronic obstructive pulmonary disease
  • (COPD)
  • Moderate COPD
  • Severe COPD
  • Uncontrolled Moderate to Severe Chronic Obstructive Pulmonary Disease
  • Exacerbations
  • Placebo
  • Type 2 inflammation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-23. This information was provided to ClinicalTrials.gov by GlaxoSmithKline on 2026-10-05. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.