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RecruitingPhase 3

Depemokimab as an Extended Treatment Duration Biologic in Adults With Chronic Obstructive Pulmonary Disease (COPD) and Type 2 Inflammation (ENDURA-2)

GlaxoSmithKline · NCT06961214

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Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 40–80 · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 3
Target enrollment
961
US sites recruiting
57
Study start
June 23, 2025
Record last updated
October 5, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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 compared as an add-on medicine in participants with uncontrolled moderate to severe COPD with type 2 inflammation.

Being studied: Depemokimab; Placebo

Conditions: Pulmonary Disease, Chronic Obstructive

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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 \< 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 and 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)

Recruiting US locations

  • GSK Investigational Site

    Sheffield, AL 35660

    Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com

  • GSK Investigational Site

    Aurora, CO 80012-5455

    Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com

  • GSK Investigational Site

    Brooksville, FL 346135

    Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com

  • GSK Investigational Site

    Doral, FL 33172

    Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com

  • GSK Investigational Site

    Fort Lauderdale, FL 33316

    Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com

  • GSK Investigational Site

    Miami, FL 33122

    Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com

  • GSK Investigational Site

    Miami, FL 33125

    Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com

  • GSK Investigational Site

    Miami, FL 33155

    Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com

  • GSK Investigational Site

    Miami, FL 33165

    Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com

  • GSK Investigational Site

    Miami, FL 33175-3434

    Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com

  • GSK Investigational Site

    Miami, FL 33176

    Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com

  • GSK Investigational Site

    Miami, FL 33176

    Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com

  • GSK Investigational Site

    Miami Lakes, FL 33016

    Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com

  • GSK Investigational Site

    Naples, FL 34102

    Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com

  • GSK Investigational Site

    New Port Richey, FL 34653

    Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com

  • GSK Investigational Site

    Ocala, FL 34471

    Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com

  • GSK Investigational Site

    Orlando, FL 32825-4457

    Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com

  • GSK Investigational Site

    Ormond Beach, FL 32174

    Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com

  • GSK Investigational Site

    Palmetto Bay, FL 33157

    Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com

  • GSK Investigational Site

    Pembroke Pines, FL 33024

    Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com

  • GSK Investigational Site

    St. Petersburg, FL 33704

    Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com

  • GSK Investigational Site

    Adairsville, GA 30103

    Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com

  • GSK Investigational Site

    Atlanta, GA 30344-3607

    Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com

  • GSK Investigational Site

    Cordele, GA 31015

    Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com

  • GSK Investigational Site

    Morrow, GA 30260

    Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com

  • GSK Investigational Site

    Boise, ID 83702

    Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com

  • GSK Investigational Site

    Chicago, IL 60608

    Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com

  • GSK Investigational Site

    Baton Rouge, LA 70816

    Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com

  • GSK Investigational Site

    Lafayette, LA 70506

    Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com

  • GSK Investigational Site

    Shreveport, LA 71105

    Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com

  • GSK Investigational Site

    Bangor, ME 04401

    Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com

  • GSK Investigational Site

    Rockville, MD 20854

    Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com

  • GSK Investigational Site

    Fall River, MA 02723-1511

    Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com

  • GSK Investigational Site

    Allen Park, MI 48101

    Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com

  • GSK Investigational Site

    Detroit, MI 48202

    Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com

  • GSK Investigational Site

    Garden City, MI 48135

    Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com

  • GSK Investigational Site

    Troy, MI 48085

    Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com

  • GSK Investigational Site

    Las Vegas, NV 89144

    Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com

  • GSK Investigational Site

    Moorestown, NJ 08057-3130

    Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com

  • GSK Investigational Site

    Sewell, NJ 08080

    Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com

  • GSK Investigational Site

    Mount Kisco, NY 10549

    Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com

  • GSK Investigational Site

    New Windsor, NY 12553

    Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com

  • GSK Investigational Site

    Shelby, NC 28152

    Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com

  • GSK Investigational Site

    DuBois, PA 15801-2277

    Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com

  • GSK Investigational Site

    Philadelphia, PA 19140

    Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com

  • GSK Investigational Site

    Spartanburg, SC 29303-4225

    Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com

  • GSK Investigational Site

    Union, SC 29379-7409

    Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com

  • GSK Investigational Site

    Knoxville, TN 37919

    Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com

  • GSK Investigational Site

    Austin, TX 78744

    Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com

  • GSK Investigational Site

    Dallas, TX 75254

    Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com

  • GSK Investigational Site

    El Paso, TX 79902-1123

    Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com

  • GSK Investigational Site

    Houston, TX 77094-1385

    Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com

  • GSK Investigational Site

    Lampasas, TX 76550-2722

    Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com

  • GSK Investigational Site

    Richmond, TX 77407

    Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com

  • GSK Investigational Site

    San Antonio, TX 78229

    Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com

  • GSK Investigational Site

    Webster, TX 77598

    Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com

  • GSK Investigational Site

    Morgantown, WV 26505-0423

    Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com

Study contacts (from the official record)

  • 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
Depemokimab as an Extended Treatment Duration Biologic in Adults… (NCT06961214) | Bored Studies