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

Last updated: April 6, 2026
Sponsor: GlaxoSmithKline
Overall Status: Active - Recruiting

Phase

3

Condition

Inflammation

Treatment

Depemokimab

Placebo

Clinical Study ID

NCT06961214
222725
2024-520417-41-00
2024-520417-41
  • Ages 40-80
  • All Genders

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

Eligibility Criteria

Inclusion

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 ThoracicSociety/European Respiratory Society for at least 1 year

  • A post-bronchodilator forced expiratory volume in one second (FEV1)/ forcedvital 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 inthe 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 cigarettesmoking of >=10 pack-years.

  • Participants should be on optimized inhaler therapy, defined as inhaledcorticosteroid (ICS) plus Long-acting muscarinic receptor antagonist (LAMA) plusLong-acting beta2-adrenergic receptor agonist (LABA) either as multiple inhalers ora 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

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 isthe primary diagnosis accounting for the clinical manifestations of the lung disease

  • Participants with pneumonia, COPD exacerbation, or lower respiratory tract infectionwithin the 4 weeks prior to Screening Visit 1

  • Lung resection: Participants with a history of or plan for lung volume reductionsurgery / endobronchial valve procedure.

  • Pulmonary rehabilitation: Participants in the acute phase of a pulmonaryrehabilitation program within 4 weeks prior to Screening Visit 1

  • Continuous oxygen: Participants requiring oxygen supplementation for more than 12hours 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 AirwayPressure [CPAP])

  • Unstable cardiovascular disease or arrhythmia

  • Parasitic Infection: Participants with a known, pre-existing parasitic infectionwithin 6 months of Screening (Visit 1)

Study Design

Total Participants: 960
Treatment Group(s): 2
Primary Treatment: Depemokimab
Phase: 3
Study Start date:
June 23, 2025
Estimated Completion Date:
August 21, 2029

Connect with a study center

  • GSK Investigational Site

    Buenos Aires, C1426ABP
    Argentina

    Active - Recruiting

  • GSK Investigational Site

    Córdoba, X5800AEV
    Argentina

    Active - Recruiting

  • GSK Investigational Site

    Quilmes, 1878
    Argentina

    Active - Recruiting

  • GSK Investigational Site

    Santa Fe, S3000ASF
    Argentina

    Active - Recruiting

  • GSK Investigational Site

    Coffs Harbour, New South Wales 2450
    Australia

    Active - Recruiting

  • GSK Investigational Site

    Maroubra, New South Wales 2035
    Australia

    Active - Recruiting

  • GSK Investigational Site

    Westmead, New South Wales 2145
    Australia

    Active - Recruiting

  • GSK Investigational Site

    Midland, Western Australia 6056
    Australia

    Active - Recruiting

  • GSK Investigational Site

    Graz, 8036
    Austria

    Active - Recruiting

  • GSK Investigational Site

    Innsbruck, 6020
    Austria

    Active - Recruiting

  • GSK Investigational Site

    Klagenfurt, 9020
    Austria

    Active - Recruiting

  • GSK Investigational Site

    Linz, 4020
    Austria

    Active - Recruiting

  • GSK Investigational Site

    Vienna, A-1090
    Austria

    Active - Recruiting

  • GSK Investigational Site

    Dupnitsa, 2600
    Bulgaria

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  • GSK Investigational Site

    Haskovo, 6300
    Bulgaria

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  • GSK Investigational Site

    Lovech, 5500
    Bulgaria

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    Montana, 3400
    Bulgaria

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    Pleven, 5800
    Bulgaria

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    Rousse, 7002
    Bulgaria

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  • GSK Investigational Site

    Sofia, 1510
    Bulgaria

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    Jindřichův Hradec, 377 01
    Czechia

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  • GSK Investigational Site

    Kralupy nad Vltavou, 278 01
    Czechia

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  • GSK Investigational Site

    Nymburk, 288 02
    Czechia

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    Prague, 12000
    Czechia

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    Varnsdorf, 407 47
    Czechia

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    Munich, Bavaria 80335
    Germany

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    Offenbach, Hesse 63065
    Germany

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    Rheine, North Rhine-Westphalia 48431
    Germany

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    Bendorf, 56170
    Germany

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    Berlin, 10625
    Germany

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    Darmstadt, 64283
    Germany

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    Essen, 45127
    Germany

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    Fürstenwalde, 15517
    Germany

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    Geesthacht, 21502
    Germany

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    Giessen, 35392
    Germany

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    Halle, 6108
    Germany

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    Immenhausen, 34376
    Germany

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    Leipzig, 04347
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    Lübeck, 23552
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    Schleswig, 24837
    Germany

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    Exochi, Thessaloniki 57010
    Greece

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    Alexandroupoli, 68100
    Greece

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    Athens, 115 21
    Greece

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    Ioannina, 45500
    Greece

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    Marousi, 151 25
    Greece

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    Ashkelon, 7830604
    Israel

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    Beer-Yaakov, 703000
    Israel

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    Beersheba, 84101
    Israel

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    Haifa, 3436212
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    Jerusalem, 90000
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    Kfar Saba, 44281
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    Petah Tikva, 49100
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    Ramat Gan, 52621
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    Catania, 95123
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    Ferrara, 44124
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    Foggia, 71122
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    Genova, 16132
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    Roma, 00161
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    Telese Terme, 82037
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    Daugavpils, LV5410
    Latvia

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    Riga, LV 1079
    Latvia

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    Takapuna, Auckland 0622
    New Zealand

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    Auckland, 1051
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    Christchurch, 8023
    New Zealand

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    Ebdentown, 5018
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    Hamilton, 3240
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    Rotorua, 3010
    New Zealand

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    Oradea, Bihor County 410155
    Romania

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    Timișoara, Timiș County 300310
    Romania

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    Bucharest, 061692
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    Cluj-Napoca, 400371
    Romania

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    Constanța, 900002
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    Seoul, 5030
    South Korea

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    Corby, NN17 2UR
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    Dagenham, RM9 5NH
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    Glasgow, G4 0SF
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    Fort Lauderdale, Florida 33316
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    Miami, Florida 33175
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    Miami Lakes, Florida 33016
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    Naples, Florida 34102
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    New Port Richey, Florida 34653
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    Ocala, Florida 34471
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    Orlando, Florida 32825
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    Ormond Beach, Florida 32174
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    Palmetto Bay, Florida 33157
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    Cordele, Georgia 31015
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    East Point, Georgia 30344
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    Morrow, Georgia 30260
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    Boise, Idaho 83702
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    Chicago, Illinois 60608
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    Baton Rouge, Louisiana 70816
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    Lafayette, Louisiana 70506
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  • GSK Investigational Site

    Shreveport, Louisiana 71105
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    Bangor, Maine 04401
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    Rockville, Maryland 20854
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  • GSK Investigational Site

    Allen Park, Michigan 48101
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  • GSK Investigational Site

    Detroit, Michigan 48202
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    Garden City, Michigan 48135
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    Troy, Michigan 48085
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  • GSK Investigational Site

    Las Vegas, Nevada 89144
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    Moorestown, New Jersey 08057
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    Sewell, New Jersey 08080
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    Mount Kisco, New York 10549
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    New Windsor, New York 12553
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    Shelby, North Carolina 28152
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    DuBois, Pennsylvania 15801
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    Philadelphia, Pennsylvania 19140
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    Spartanburg, South Carolina 29303
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    Union, South Carolina 29379
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    Knoxville, Tennessee 37919
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    Austin, Texas 78744
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  • GSK Investigational Site

    Dallas, Texas 75254
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    El Paso, Texas 79902-1123
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    Houston, Texas 77094
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    Lampasas, Texas 76550
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    Richmond, Texas 77407
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  • GSK Investigational Site

    San Antonio, Texas 78229
    United States

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  • GSK Investigational Site

    Webster, Texas 77598
    United States

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  • GSK Investigational Site

    Morgantown, West Virginia 26505-0423
    United States

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