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

Recruitment Status
RECRUITING
(See Contacts and Locations)Verified March 2026 by GlaxoSmithKline
Sponsor
GlaxoSmithKline
Information Provided by (Responsible Party)
GlaxoSmithKline
Clinicaltrials.gov Identifier
NCT06961214
Other Study ID Numbers:
222725
First Submitted
April 28, 2025
First Posted
May 6, 2025
Last Update Posted
April 8, 2026
Last Verified
March 2026

ClinicalTrials.gov processed this data on April 2026. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

Condition or DiseaseIntervention/Treatment
Pulmonary Disease, Chronic Obstructive
Drug: DepemokimabDrug: Placebo

Study Design

Study TypeInterventional
Actual Enrollment960 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingQuadruple
Primary PurposeTreatment
Official TitleA 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
Study Start DateJune 22, 2025
Actual Primary Completion Date3yrs 3mos from now
Actual Study Completion Date3yrs 3mos from now

Groups and Cohorts

Group/CohortIntervention/Treatment
Depemokimab
Participants will be administered subcutaneous (SC) injection of Depemokimab along with standard of care (SoC).
Drug: Depemokimab
Depemokimab as a sterile liquid formulation will be administered.
Placebo
Participants will be administered placebo along with SoC.
Drug: Placebo
Placebo as a sterile 0.9 percent (%) sodium chloride solution will be administered

Outcome Measures

Primary Outcome Measures
  1. Annualized Rate of Moderate/Severe Exacerbations
    Moderate exacerbations are defined as clinically significant exacerbations that require treatment with oral/systemic corticosteroids and/or antibiotics. Severe exacerbations are defined as clinically significant exacerbations that require in-patient hospitalization (i.e., greater than or equal to \[\>=\] 24 hours) or result in death. The frequency of moderate/ severe exacerbations expressed as an annualized exacerbation rate will be evaluated.
Secondary Outcome Measures
  1. Time to First Moderate/Severe Exacerbation
    Moderate exacerbations are defined as clinically significant exacerbations that require treatment with oral/systemic corticosteroids and/or antibiotics. Severe exacerbations are defined as clinically significant exacerbations that require in-patient hospitalization (i.e., greater than or equal to \[\>=\] 24 hours) or result in death.
  2. Change from Baseline in St. George's Respiratory Questionnaire (SGRQ) Total Score at Week 52
    The SGRQ total score will be measured using the SGRQ for COPD \[SGRQ-C\]. The SGRQ-C is a 40-item participant questionnaire designed to measure health impairment by addressing the frequency of respiratory symptoms (questions 1-7) and the participant's current state (questions 8-14). The questions are designed to be self-completed by the participant. The total score will be calculated on 0-100 rating scale and scores expressed as a percentage of overall impairment. Higher scores indicate greater impairment of health.
  3. Change from Baseline in Evaluating Respiratory Symptoms in Chronic Obstructive Pulmonary Disease (E-RS: COPD) Total Score at Week 52
    E-RS: COPD consists of 11 items from the 14-item Exacerbations of Chronic Pulmonary Disease Tool - Patient Reported Outcomes (EXACT) instrument. E-RS: COPD is intended to capture information related to the respiratory symptoms of COPD, i.e., breathlessness, cough, sputum production, chest congestion, and chest tightness. The E-RS: COPD has a scoring range of 0 to 40, higher scores indicate more severe symptoms.
  4. Annualized Rate of Exacerbations Requiring Emergency Department (ED) Visit or Hospitalization
    Annualized rate of exacerbations requiring ED Visit or Hospitalization (For pooled analysis across studies 222714 and 222725) will be assessed.
  5. Annualized Rate of Severe Exacerbations
    Severe exacerbations are defined as clinically significant exacerbations that require in-patient hospitalization (i.e., greater than or equal to \[\>=\] 24 hours) or result in death. Annualized rate of severe exacerbations (For pooled analysis across studies 222714 and 222725) will be assessed.

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
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)

Contacts and Locations

Sponsors and CollaboratorsGlaxoSmithKline
Locations
GSK Investigational Site | Sheffield Alabama, United States, 35660GSK Investigational Site | Aurora Colorado, United States, 80012GSK Investigational Site | Brooksville Florida, United States, 346135GSK Investigational Site | Doral Florida, United States, 33172GSK Investigational Site | Fort Lauderdale Florida, United States, 33316GSK Investigational Site | Miami Florida, United States, 33122GSK Investigational Site | Miami Florida, United States, 33125GSK Investigational Site | Miami Florida, United States, 33155GSK Investigational Site | Miami Florida, United States, 33165GSK Investigational Site | Miami Florida, United States, 33175GSK Investigational Site | Miami Florida, United States, 33176GSK Investigational Site | Miami Florida, United States, 33176GSK Investigational Site | Miami Lakes Florida, United States, 33016GSK Investigational Site | Naples Florida, United States, 34102GSK Investigational Site | New Port Richey Florida, United States, 34653GSK Investigational Site | Ocala Florida, United States, 34471GSK Investigational Site | Orlando Florida, United States, 32825GSK Investigational Site | Ormond Beach Florida, United States, 32174GSK Investigational Site | Palmetto Bay Florida, United States, 33157GSK Investigational Site | St. Petersburg Florida, United States, 33704GSK Investigational Site | Adairsville Georgia, United States, 30103GSK Investigational Site | Cordele Georgia, United States, 31015GSK Investigational Site | East Point Georgia, United States, 30344GSK Investigational Site | Morrow Georgia, United States, 30260GSK Investigational Site | Boise Idaho, United States, 83702GSK Investigational Site | Chicago Illinois, United States, 60608GSK Investigational Site | Baton Rouge Louisiana, United States, 70816GSK Investigational Site | Lafayette Louisiana, United States, 70506GSK Investigational Site | Shreveport Louisiana, United States, 71105GSK Investigational Site | Bangor Maine, United States, 04401GSK Investigational Site | Rockville Maryland, United States, 20854GSK Investigational Site | Allen Park Michigan, United States, 48101GSK Investigational Site | Detroit Michigan, United States, 48202GSK Investigational Site | Garden City Michigan, United States, 48135GSK Investigational Site | Troy Michigan, United States, 48085GSK Investigational Site | Las Vegas Nevada, United States, 89144GSK Investigational Site | Moorestown New Jersey, United States, 08057GSK Investigational Site | Sewell New Jersey, United States, 08080GSK Investigational Site | Mount Kisco New York, United States, 10549GSK Investigational Site | New Windsor New York, United States, 12553GSK Investigational Site | Shelby North Carolina, United States, 28152GSK Investigational Site | DuBois Pennsylvania, United States, 15801GSK Investigational Site | Philadelphia Pennsylvania, United States, 19140GSK Investigational Site | Spartanburg South Carolina, United States, 29303GSK Investigational Site | Union South Carolina, United States, 29379GSK Investigational Site | Knoxville Tennessee, United States, 37919GSK Investigational Site | Austin Texas, United States, 78744GSK Investigational Site | Dallas Texas, United States, 75254GSK Investigational Site | El Paso Texas, United States, 79902-1123GSK Investigational Site | Houston Texas, United States, 77094GSK Investigational Site | Lampasas Texas, United States, 76550GSK Investigational Site | Richmond Texas, United States, 77407GSK Investigational Site | San Antonio Texas, United States, 78229GSK Investigational Site | Webster Texas, United States, 77598GSK Investigational Site | Morgantown West Virginia, United States, 26505-0423GSK Investigational Site | Buenos Aires , Argentina, C1425BADGSK Investigational Site | Buenos Aires , Argentina, C1426ABPGSK Investigational Site | Córdoba , Argentina, X5800AEVGSK Investigational Site | Quilmes , Argentina, 1878GSK Investigational Site | Santa Fe , Argentina, S3000ASFGSK Investigational Site | Coffs Harbour New South Wales, Australia, 2450GSK Investigational Site | Maroubra New South Wales, Australia, 2035GSK Investigational Site | Westmead New South Wales, Australia, 2145GSK Investigational Site | Midland Western Australia, Australia, 6056GSK Investigational Site | Graz , Austria, 8036GSK Investigational Site | Innsbruck , Austria, 6020GSK Investigational Site | Klagenfurt , Austria, 9020GSK Investigational Site | Linz , Austria, 4020GSK Investigational Site | Linz , Austria, 4020GSK Investigational Site | Linz , Austria, 4021GSK Investigational Site | Vienna , Austria, A-1090GSK Investigational Site | Dupnitsa , Bulgaria, 2600GSK Investigational Site | Haskovo , Bulgaria, 6300GSK Investigational Site | Lovech , Bulgaria, 5500GSK Investigational Site | Montana , Bulgaria, 3400GSK Investigational Site | Montana , Bulgaria, 3400GSK Investigational Site | Pleven , Bulgaria, 5800GSK Investigational Site | Rousse , Bulgaria, 7002GSK Investigational Site | Rousse , Bulgaria, 7002GSK Investigational Site | Sofia , Bulgaria, 1510GSK Investigational Site | Sofia , Bulgaria, 1680GSK Investigational Site | Jindřichův Hradec , Czechia, 377 01GSK Investigational Site | Kralupy nad Vltavou , Czechia, 278 01GSK Investigational Site | Nymburk , Czechia, 288 02GSK Investigational Site | Prague , Czechia, 12000GSK Investigational Site | Varnsdorf , Czechia, 407 47GSK Investigational Site | Munich Bavaria, Germany, 80335GSK Investigational Site | Offenbach Hesse, Germany, 63065GSK Investigational Site | Rheine North Rhine-Westphalia, Germany, 48431GSK Investigational Site | Bendorf , Germany, 56170GSK Investigational Site | Berlin , Germany, 10119GSK Investigational Site | Berlin , Germany, 10625GSK Investigational Site | Berlin , Germany, 10717GSK Investigational Site | Berlin , Germany, 10961GSK Investigational Site | Berlin , Germany, 12203GSK Investigational Site | Berlin , Germany, 12627GSK Investigational Site | Berlin , Germany, 13187GSK Investigational Site | Darmstadt , Germany, 64283GSK Investigational Site | Essen , Germany, 45127GSK Investigational Site | Fürstenwalde , Germany, 15517GSK Investigational Site | Geesthacht , Germany, 21502GSK Investigational Site | Giessen , Germany, 35392GSK Investigational Site | Halle , Germany, 6108GSK Investigational Site | Immenhausen , Germany, 34376GSK Investigational Site | Leipzig , Germany, 04207GSK Investigational Site | Leipzig , Germany, 04299GSK Investigational Site | Leipzig , Germany, 04347GSK Investigational Site | Lübeck , Germany, 23552GSK Investigational Site | Schleswig , Germany, 24837GSK Investigational Site | Exochi Thessaloniki, Greece, 57010GSK Investigational Site | Alexandroupoli , Greece, 68100GSK Investigational Site | Athens , Greece, 115 21GSK Investigational Site | Ioannina , Greece, 45500GSK Investigational Site | Marousi , Greece, 151 25GSK Investigational Site | Ashkelon , Israel, 7830604GSK Investigational Site | Beer-Yaakov , Israel, 703000GSK Investigational Site | Beersheba , Israel, 84101GSK Investigational Site | Haifa , Israel, 30000GSK Investigational Site | Haifa , Israel, 3109601GSK Investigational Site | Haifa , Israel, 3436212GSK Investigational Site | Jerusalem , Israel, 90000GSK Investigational Site | Jerusalem , Israel, 91031GSK Investigational Site | Kfar Saba , Israel, 44281GSK Investigational Site | Petah Tikva , Israel, 49100GSK Investigational Site | Ramat Gan , Israel, 52621GSK Investigational Site | Catania , Italy, 95123GSK Investigational Site | Ferrara , Italy, 44124GSK Investigational Site | Foggia , Italy, 71122GSK Investigational Site | Genova , Italy, 16132GSK Investigational Site | Roma , Italy, 00128GSK Investigational Site | Roma , Italy, 00133GSK Investigational Site | Roma , Italy, 00161GSK Investigational Site | Telese Terme , Italy, 82037GSK Investigational Site | Daugavpils , Latvia, LV5410GSK Investigational Site | Riga , Latvia, LV 1079GSK Investigational Site | Riga , Latvia, LV-1002GSK Investigational Site | Takapuna Auckland, New Zealand, 0622GSK Investigational Site | Auckland , New Zealand, 1051GSK Investigational Site | Auckland , New Zealand, 1051GSK Investigational Site | Christchurch , New Zealand, 8023GSK Investigational Site | Ebdentown , New Zealand, 5018GSK Investigational Site | Hamilton , New Zealand, 3240GSK Investigational Site | Rotorua , New Zealand, 3010GSK Investigational Site | Oradea Bihor County, Romania, 410155GSK Investigational Site | Oradea Bihor County, Romania, 410176GSK Investigational Site | Timișoara Timiș County, Romania, 300310GSK Investigational Site | Bucharest , Romania, 061692GSK Investigational Site | Cluj-Napoca , Romania, 400275GSK Investigational Site | Cluj-Napoca , Romania, 400371GSK Investigational Site | Constanța , Romania, 900002GSK Investigational Site | Seoul , South Korea, 03181GSK Investigational Site | Seoul , South Korea, 5030GSK Investigational Site | Corby , United Kingdom, NN17 2URGSK Investigational Site | Dagenham , United Kingdom, RM9 5NHGSK Investigational Site | Glasgow , United Kingdom, G20 7BEGSK Investigational Site | Glasgow , United Kingdom, G4 0SFGSK Investigational Site | London , United Kingdom, N8 0RAGSK Investigational Site | London , United Kingdom, NW10 2PBGSK Investigational Site | Uxbridge , United Kingdom, UB8 3NN
Investigators
Study Director: GSK Clinical Trials, GlaxoSmithKline