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

Oct, 2025

Completion date

Aug 20, 2029

Anticipated

Primary completion date

Aug 20, 2029

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 12 hours per day.
  • 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

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, 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

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

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 D Updegrove

More Information

Sponsor

GlaxoSmithKline

Last update posted

Oct 8, 2025

Last verified

Oct, 2025

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 2026-09-09. This information was provided to ClinicalTrials.gov by GlaxoSmithKline on 2025-10-08.