← Back to searchRecruitingRecruiting
Depemokimab as an Extended treatmeNt Duration Biologic in Adults With Chronic Obstructive Pulmonary Disease (COPD) and Type 2 Inflammation (ENDURA-2)
NCT06961214 · GlaxoSmithKline
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official title
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study of the Efficacy and Safety of Depemokimab in Adult Participants With COPD With Type 2 Inflammation
About this study
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.
Eligibility 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 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 target: 960 participants
Allocation: randomized
Masking: quadruple
Age groups: adult, older_adult
Timeline
Starts: 2025-06-23
Estimated completion: 2029-08-21
Last updated: 2026-04-09
Interventions
Drug: DepemokimabDrug: Placebo
Primary outcomes
- • Annualized Rate of Moderate/Severe Exacerbations (From Baseline up to Week 104)
Sponsor
GlaxoSmithKline · industry
Contacts & investigators
ContactUS GSK Clinical Trials Call Center · contact · GSKClinicalSupportHD@gsk.com · 877-379-3718
ContactEU GSK Clinical Trials Call Center · contact · GSKClinicalSupportHD@gsk.com · +44 (0) 20 89904466
InvestigatorGSK Clinical Trials · study_director, GlaxoSmithKline
All locations (159)
GSK Investigational SiteRecruiting
Sheffield, Alabama, United States
GSK Investigational SiteRecruiting
Aurora, Colorado, United States
GSK Investigational SiteRecruiting
Brooksville, Florida, United States
GSK Investigational SiteRecruiting
Doral, Florida, United States
GSK Investigational SiteRecruiting
Fort Lauderdale, Florida, United States
GSK Investigational SiteRecruiting
Miami, Florida, United States
GSK Investigational SiteRecruiting
Miami, Florida, United States
GSK Investigational SiteRecruiting
Miami, Florida, United States
GSK Investigational SiteRecruiting
Miami, Florida, United States
GSK Investigational SiteRecruiting
Miami, Florida, United States
GSK Investigational SiteRecruiting
Miami, Florida, United States
GSK Investigational SiteRecruiting
Miami, Florida, United States
GSK Investigational SiteRecruiting
Miami Lakes, Florida, United States
GSK Investigational SiteRecruiting
Naples, Florida, United States
GSK Investigational SiteRecruiting
New Port Richey, Florida, United States
GSK Investigational SiteRecruiting
Ocala, Florida, United States
GSK Investigational SiteRecruiting
Orlando, Florida, United States
GSK Investigational SiteRecruiting
Ormond Beach, Florida, United States
GSK Investigational SiteRecruiting
Palmetto Bay, Florida, United States
GSK Investigational SiteRecruiting
St. Petersburg, Florida, United States
GSK Investigational SiteRecruiting
Adairsville, Georgia, United States
GSK Investigational SiteRecruiting
Cordele, Georgia, United States
GSK Investigational SiteRecruiting
East Point, Georgia, United States
GSK Investigational SiteRecruiting
Morrow, Georgia, United States
GSK Investigational SiteRecruiting
Boise, Idaho, United States
GSK Investigational SiteRecruiting
Chicago, Illinois, United States
GSK Investigational SiteRecruiting
Baton Rouge, Louisiana, United States
GSK Investigational SiteRecruiting
Lafayette, Louisiana, United States
GSK Investigational SiteRecruiting
Shreveport, Louisiana, United States
GSK Investigational SiteRecruiting
Bangor, Maine, United States
GSK Investigational SiteRecruiting
Rockville, Maryland, United States
GSK Investigational SiteRecruiting
Allen Park, Michigan, United States
GSK Investigational SiteRecruiting
Detroit, Michigan, United States
GSK Investigational SiteRecruiting
Garden City, Michigan, United States
GSK Investigational SiteRecruiting
Troy, Michigan, United States
GSK Investigational SiteRecruiting
Las Vegas, Nevada, United States
GSK Investigational SiteRecruiting
Moorestown, New Jersey, United States
GSK Investigational SiteRecruiting
Sewell, New Jersey, United States
GSK Investigational SiteRecruiting
Mount Kisco, New York, United States
GSK Investigational SiteRecruiting
New Windsor, New York, United States
GSK Investigational SiteRecruiting
Shelby, North Carolina, United States
GSK Investigational SiteRecruiting
DuBois, Pennsylvania, United States
GSK Investigational SiteRecruiting
Philadelphia, Pennsylvania, United States
GSK Investigational SiteRecruiting
Spartanburg, South Carolina, United States
GSK Investigational SiteRecruiting
Union, South Carolina, United States
GSK Investigational SiteRecruiting
Knoxville, Tennessee, United States
GSK Investigational SiteRecruiting
Austin, Texas, United States
GSK Investigational SiteRecruiting
Dallas, Texas, United States
GSK Investigational SiteRecruiting
El Paso, Texas, United States
GSK Investigational SiteRecruiting
Houston, Texas, United States
GSK Investigational SiteRecruiting
Lampasas, Texas, United States
GSK Investigational SiteRecruiting
Richmond, Texas, United States
GSK Investigational SiteRecruiting
San Antonio, Texas, United States
GSK Investigational SiteRecruiting
Webster, Texas, United States
GSK Investigational SiteRecruiting
Morgantown, West Virginia, United States
GSK Investigational SiteRecruiting
Buenos Aires, Argentina
GSK Investigational SiteRecruiting
Buenos Aires, Argentina
GSK Investigational SiteRecruiting
Córdoba, Argentina
GSK Investigational SiteRecruiting
Quilmes, Argentina
GSK Investigational SiteRecruiting
Santa Fe, Argentina
GSK Investigational SiteRecruiting
Coffs Harbour, New South Wales, Australia
GSK Investigational SiteRecruiting
Maroubra, New South Wales, Australia
GSK Investigational SiteRecruiting
Westmead, New South Wales, Australia
GSK Investigational SiteRecruiting
Midland, Western Australia, Australia
GSK Investigational SiteRecruiting
Graz, Austria
GSK Investigational SiteRecruiting
Innsbruck, Austria
GSK Investigational SiteRecruiting
Klagenfurt, Austria
GSK Investigational SiteRecruiting
Linz, Austria
GSK Investigational SiteRecruiting
Linz, Austria
GSK Investigational SiteRecruiting
Linz, Austria
GSK Investigational SiteRecruiting
Vienna, Austria
GSK Investigational SiteRecruiting
Dupnitsa, Bulgaria
GSK Investigational SiteRecruiting
Haskovo, Bulgaria
GSK Investigational SiteRecruiting
Lovech, Bulgaria
GSK Investigational SiteRecruiting
Montana, Bulgaria
GSK Investigational SiteRecruiting
Montana, Bulgaria
GSK Investigational SiteRecruiting
Pleven, Bulgaria
GSK Investigational SiteRecruiting
Rousse, Bulgaria
GSK Investigational SiteRecruiting
Rousse, Bulgaria
GSK Investigational SiteRecruiting
Sofia, Bulgaria
GSK Investigational SiteRecruiting
Sofia, Bulgaria
GSK Investigational SiteRecruiting
Jindřichův Hradec, Czechia
GSK Investigational SiteRecruiting
Kralupy nad Vltavou, Czechia
GSK Investigational SiteRecruiting
Nymburk, Czechia
GSK Investigational SiteRecruiting
Prague, Czechia
GSK Investigational SiteRecruiting
Varnsdorf, Czechia
GSK Investigational SiteRecruiting
Munich, Bavaria, Germany
GSK Investigational SiteRecruiting
Offenbach, Hesse, Germany
GSK Investigational SiteRecruiting
Rheine, North Rhine-Westphalia, Germany
GSK Investigational SiteRecruiting
Bendorf, Germany
GSK Investigational SiteRecruiting
Berlin, Germany
GSK Investigational SiteRecruiting
Berlin, Germany
GSK Investigational SiteRecruiting
Berlin, Germany
GSK Investigational SiteRecruiting
Berlin, Germany
GSK Investigational SiteRecruiting
Berlin, Germany
GSK Investigational SiteRecruiting
Berlin, Germany
GSK Investigational SiteRecruiting
Berlin, Germany
GSK Investigational SiteRecruiting
Darmstadt, Germany
GSK Investigational SiteRecruiting
Essen, Germany
GSK Investigational SiteRecruiting
Fürstenwalde, Germany
GSK Investigational SiteRecruiting
Geesthacht, Germany
GSK Investigational SiteRecruiting
Giessen, Germany
GSK Investigational SiteRecruiting
Halle, Germany
GSK Investigational SiteRecruiting
Immenhausen, Germany
GSK Investigational SiteRecruiting
Leipzig, Germany
GSK Investigational SiteRecruiting
Leipzig, Germany
GSK Investigational SiteRecruiting
Leipzig, Germany
GSK Investigational SiteRecruiting
Lübeck, Germany
GSK Investigational SiteRecruiting
Schleswig, Germany
GSK Investigational SiteRecruiting
Exochi, Thessaloniki, Greece
GSK Investigational SiteRecruiting
Alexandroupoli, Greece
GSK Investigational SiteRecruiting
Athens, Greece
GSK Investigational SiteRecruiting
Ioannina, Greece
GSK Investigational SiteRecruiting
Marousi, Greece
GSK Investigational SiteRecruiting
Ashkelon, Israel
GSK Investigational SiteRecruiting
Beer-Yaakov, Israel
GSK Investigational SiteRecruiting
Beersheba, Israel
GSK Investigational SiteRecruiting
Haifa, Israel
GSK Investigational SiteRecruiting
Haifa, Israel
GSK Investigational SiteRecruiting
Haifa, Israel
GSK Investigational SiteRecruiting
Jerusalem, Israel
GSK Investigational SiteRecruiting
Jerusalem, Israel
GSK Investigational SiteRecruiting
Kfar Saba, Israel
GSK Investigational SiteRecruiting
Petah Tikva, Israel
GSK Investigational SiteRecruiting
Ramat Gan, Israel
GSK Investigational SiteRecruiting
Catania, Italy
GSK Investigational SiteRecruiting
Ferrara, Italy
GSK Investigational SiteRecruiting
Foggia, Italy
GSK Investigational SiteRecruiting
Genova, Italy
GSK Investigational SiteRecruiting
Roma, Italy
GSK Investigational SiteRecruiting
Roma, Italy
GSK Investigational SiteRecruiting
Roma, Italy
GSK Investigational SiteRecruiting
Telese Terme, Italy
GSK Investigational SiteRecruiting
Daugavpils, Latvia
GSK Investigational SiteRecruiting
Riga, Latvia
GSK Investigational SiteRecruiting
Riga, Latvia
GSK Investigational SiteRecruiting
Takapuna, Auckland, New Zealand
GSK Investigational SiteRecruiting
Auckland, New Zealand
GSK Investigational SiteRecruiting
Auckland, New Zealand
GSK Investigational SiteRecruiting
Christchurch, New Zealand
GSK Investigational SiteRecruiting
Ebdentown, New Zealand
GSK Investigational SiteRecruiting
Hamilton, New Zealand
GSK Investigational SiteRecruiting
Rotorua, New Zealand
GSK Investigational SiteRecruiting
Oradea, Bihor County, Romania
GSK Investigational SiteRecruiting
Oradea, Bihor County, Romania
GSK Investigational SiteRecruiting
Timișoara, Timiș County, Romania
GSK Investigational SiteRecruiting
Bucharest, Romania
GSK Investigational SiteRecruiting
Cluj-Napoca, Romania
GSK Investigational SiteRecruiting
Cluj-Napoca, Romania
GSK Investigational SiteRecruiting
Constanța, Romania
GSK Investigational SiteRecruiting
Seoul, South Korea
GSK Investigational SiteRecruiting
Seoul, South Korea
GSK Investigational SiteRecruiting
Corby, United Kingdom
GSK Investigational SiteRecruiting
Dagenham, United Kingdom
GSK Investigational SiteRecruiting
Glasgow, United Kingdom
GSK Investigational SiteRecruiting
Glasgow, United Kingdom
GSK Investigational SiteRecruiting
London, United Kingdom
GSK Investigational SiteRecruiting
London, United Kingdom
GSK Investigational SiteRecruiting
Uxbridge, United Kingdom