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

April 6, 2026 updated by: GlaxoSmithKline

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

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.

Study Overview

Status

Recruiting

Intervention / Treatment

Detailed Description

Click here to enter text.

Study Type

Interventional

Enrollment (Estimated)

960

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

      • Buenos Aires, Argentina, C1426ABP
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Pablo Doreski
      • Buenos Aires, Argentina, C1425BAD
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Nicolas Itcovici
        • Contact:
        • Contact:
      • Córdoba, Argentina, X5800AEV
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Fernando Bordese
      • Quilmes, Argentina, 1878
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Julian Mereles
      • Santa Fe, Argentina, S3000ASF
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Martin Maillo
    • New South Wales
      • Coffs Harbour, New South Wales, Australia, 2450
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Olga Voloshyna
      • Maroubra, New South Wales, Australia, 2035
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Mark Arya
      • Westmead, New South Wales, Australia, 2145
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Stephen Milne
    • Western Australia
      • Midland, Western Australia, Australia, 6056
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • David Manners
      • Graz, Austria, 8036
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Katrin Milger
      • Innsbruck, Austria, 6020
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Thomas Sonnweber
      • Klagenfurt, Austria, 9020
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Daniel Doberer
      • Linz, Austria, 4020
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Michael Wuertz
      • Linz, Austria, 4021
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Andreas Horner
      • Vienna, Austria, A-1090
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Marco Idzko
      • Dupnitsa, Bulgaria, 2600
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Elena Gyuzeleva
      • Haskovo, Bulgaria, 6300
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Veselin Kalfov
      • Lovech, Bulgaria, 5500
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Mihail Kirov
      • Montana, Bulgaria, 3400
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Vanko Vankov
      • Pleven, Bulgaria, 5800
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Mariya Todorova
      • Rousse, Bulgaria, 7002
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Hristo Metev
      • Sofia, Bulgaria, 1510
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Kiril Palaveev
      • Sofia, Bulgaria, 1680
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Georgi Hinkov
      • Jindřichův Hradec, Czechia, 377 01
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Petr Kopecký jr
      • Kralupy nad Vltavou, Czechia, 278 01
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Otakar Hokynar
      • Nymburk, Czechia, 288 02
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Sarka Klimesova
      • Prague, Czechia, 12000
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Zuzana Bouckova
      • Varnsdorf, Czechia, 407 47
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Milan Sklenar
      • Bendorf, Germany, 56170
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Olaf Schmidt
        • Contact:
        • Contact:
      • Berlin, Germany, 12203
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Thomas Schultz
        • Contact:
        • Contact:
      • Berlin, Germany, 10119
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Lennart Schaper
        • Contact:
        • Contact:
      • Berlin, Germany, 10717
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Bjoern Martens
      • Berlin, Germany, 12627
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jens Driemert
      • Berlin, Germany, 10961
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Hilke Temme
      • Berlin, Germany, 10625
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Thomas Lienert
      • Berlin, Germany, 13187
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ishak Teber
      • Darmstadt, Germany, 64283
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Andreas Forster
      • Essen, Germany, 45127
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Sivagurunathan Sutharsan
      • Fürstenwalde, Germany, 15517
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Athanasios Xanthopoulos
        • Contact:
        • Contact:
      • Geesthacht, Germany, 21502
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Wolfgang Zachgo
        • Contact:
        • Contact:
      • Giessen, Germany, 35392
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Andreas Guenther
      • Halle, Germany, 6108
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Peter-Uwe Haase
      • Immenhausen, Germany, 34376
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Peter Hammerl
        • Contact:
        • Contact:
      • Leipzig, Germany, 04207
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Regina Deckelmann
        • Contact:
        • Contact:
      • Leipzig, Germany, 04299
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Andreas Bonitz
      • Leipzig, Germany, 04347
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Falk Brunner
      • Lübeck, Germany, 23552
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Nakul Modi
      • Schleswig, Germany, 24837
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Andreas Deimling
    • Bavaria
      • Munich, Bavaria, Germany, 80335
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Korkut Avsar
    • Hesse
      • Offenbach, Hesse, Germany, 63065
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Florieke Berfelo
    • North Rhine-Westphalia
      • Rheine, North Rhine-Westphalia, Germany, 48431
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Marc Hoeffgen
        • Contact:
        • Contact:
      • Alexandroupoli, Greece, 68100
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Paschalis Steiropoulos
        • Contact:
        • Contact:
      • Athens, Greece, 115 21
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Nikolaos Zias
      • Ioannina, Greece, 45500
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Konstantinos Kostikas
        • Contact:
        • Contact:
      • Marousi, Greece, 151 25
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Anastasios Palamidas
    • Thessaloniki
      • Exochi, Thessaloniki, Greece, 57010
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Konstantinos Porpodis
        • Contact:
        • Contact:
      • Ashkelon, Israel, 7830604
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ori Wand
      • Beer-Yaakov, Israel, 703000
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Benjamin Fox
        • Contact:
        • Contact:
      • Beersheba, Israel, 84101
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Yael Raviv
      • Haifa, Israel, 3436212
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Yochai Adir
        • Contact:
        • Contact:
      • Haifa, Israel, 3109601
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Yaniv Dotan
      • Haifa, Israel, 30000
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Emilia Hardak
      • Jerusalem, Israel, 91031
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Gabriel Izbicki
        • Contact:
        • Contact:
      • Jerusalem, Israel, 90000
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Neville Berkman
      • Kfar Saba, Israel, 44281
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • David Shitrit
        • Contact:
        • Contact:
      • Petah Tikva, Israel, 49100
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Osnat Shtraichman
      • Ramat Gan, Israel, 52621
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Michael Peled
      • Catania, Italy, 95123
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Lucia Spicuzza
      • Ferrara, Italy, 44124
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Alberto Papi
        • Contact:
        • Contact:
      • Foggia, Italy, 71122
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Donato Lacedonia
      • Genova, Italy, 16132
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Fulvio Braido
      • Roma, Italy, 00128
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Simone Scarlata
      • Roma, Italy, 00161
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Matteo Bonini
      • Roma, Italy, 00133
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Paola Rogliani
      • Telese Terme, Italy, 82037
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Mauro Maniscalco
        • Contact:
        • Contact:
      • Daugavpils, Latvia, LV5410
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Lilita Mitrofanova
      • Riga, Latvia, LV 1079
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Inga Stukena
      • Riga, Latvia, LV-1002
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Aurika Babjoniseva
      • Auckland, New Zealand, 1051
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Syed Hussain
      • Christchurch, New Zealand, 8023
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Benjamin Image
      • Ebdentown, New Zealand, 5018
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Tim Humphrey
      • Hamilton, New Zealand, 3240
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Catherina Chang
        • Contact:
        • Contact:
      • Rotorua, New Zealand, 3010
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • James Stanley
    • Auckland
      • Takapuna, Auckland, New Zealand, 0622
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Paul Hamilton
        • Contact:
        • Contact:
      • Bucharest, Romania, 061692
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Magdalena Ciobanu
      • Cluj-Napoca, Romania, 400275
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Bogdan Mihai Mincu
      • Cluj-Napoca, Romania, 400371
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Manuela Magdau
      • Constanța, Romania, 900002
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ghiulten Apti
    • Bihor County
      • Oradea, Bihor County, Romania, 410155
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Lavinia Davidescu
      • Oradea, Bihor County, Romania, 410176
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Mircea Marta
    • Timiș County
      • Timișoara, Timiș County, Romania, 300310
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ionela Iovan
      • Seoul, South Korea, 5030
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Kwang Ha Yoo
      • Seoul, South Korea, 03181
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Seong-Yong Lim
      • Corby, United Kingdom, NN17 2UR
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Amardeep Heer
      • Dagenham, United Kingdom, RM9 5NH
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Suman Paul
      • Glasgow, United Kingdom, G20 7BE
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Imrozia Munsoor
      • Glasgow, United Kingdom, G4 0SF
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Hannah Bayes
      • London, United Kingdom, N8 0RA
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Suman Paul
      • London, United Kingdom, NW10 2PB
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Martin Johnson
      • Uxbridge, United Kingdom, UB8 3NN
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Samantha Kon
    • Alabama
      • Sheffield, Alabama, United States, 35660
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Aaron Karr
    • Colorado
      • Aurora, Colorado, United States, 80012
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Nathaniel Moore
    • Florida
      • Brooksville, Florida, United States, 346135
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Salman Muddassir
      • Doral, Florida, United States, 33172
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Felipe Gascon-Rodon
      • Fort Lauderdale, Florida, United States, 33316
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Frank Hull
        • Contact:
        • Contact:
      • Miami, Florida, United States, 33125
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ibrahim Menendez-Perez
      • Miami, Florida, United States, 33165
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ramses Vega
      • Miami, Florida, United States, 33155
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Jacqueline Diaz
        • Contact:
        • Contact:
      • Miami, Florida, United States, 33176
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ariel Ramirez Navarro
      • Miami, Florida, United States, 33175
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Mireya Garcia
      • Miami, Florida, United States, 33122
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Armando Ropero Cartier
      • Miami Lakes, Florida, United States, 33016
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Eduardo Andre
        • Contact:
        • Contact:
      • Naples, Florida, United States, 34102
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Lisette Delgado Sanchez
      • New Port Richey, Florida, United States, 34653
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jaime Kratz
      • Ocala, Florida, United States, 34471
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Raj Karunakara
      • Orlando, Florida, United States, 32825
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Humberto Cruz
      • Ormond Beach, Florida, United States, 32174
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Dany Obeid
        • Contact:
        • Contact:
      • Palmetto Bay, Florida, United States, 33157
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Luis Hernandez Rosado
      • St. Petersburg, Florida, United States, 33704
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Hudman Hoo
        • Contact:
        • Contact:
    • Georgia
      • Adairsville, Georgia, United States, 30103
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • John Richmond
      • Cordele, Georgia, United States, 31015
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • David Kavtaradze
      • East Point, Georgia, United States, 30344
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ngozika Orjioke
      • Morrow, Georgia, United States, 30260
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Marie Walton
    • Idaho
      • Boise, Idaho, United States, 83702
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Bill Laitinen
        • Contact:
        • Contact:
    • Illinois
      • Chicago, Illinois, United States, 60608
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Thomas Wade
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70816
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Alexander Mulamula
      • Lafayette, Louisiana, United States, 70506
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Patrick Moore
      • Shreveport, Louisiana, United States, 71105
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • David Green
    • Maine
      • Bangor, Maine, United States, 04401
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Paul Shapero
    • Maryland
      • Rockville, Maryland, United States, 20854
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Asefa Mekonnen
    • Michigan
      • Allen Park, Michigan, United States, 48101
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Syed Talib Raza
      • Detroit, Michigan, United States, 48202
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Daniel Ouellette
      • Garden City, Michigan, United States, 48135
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Renee Dwaihy
      • Troy, Michigan, United States, 48085
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Jay Sandberg
        • Contact:
        • Contact:
    • Nevada
      • Las Vegas, Nevada, United States, 89144
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Vishisht Mehta
    • New Jersey
      • Moorestown, New Jersey, United States, 08057
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Emilio Mazza
      • Sewell, New Jersey, United States, 08080
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Allen Silvey
        • Contact:
        • Contact:
    • New York
      • Mount Kisco, New York, United States, 10549
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Lisa Youkeles
      • New Windsor, New York, United States, 12553
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Sashi Makam
    • North Carolina
      • Shelby, North Carolina, United States, 28152
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Christian Martin
    • Pennsylvania
      • DuBois, Pennsylvania, United States, 15801
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Sandeep Bansal
      • Philadelphia, Pennsylvania, United States, 19140
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Gerard Criner
    • South Carolina
      • Spartanburg, South Carolina, United States, 29303
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Principal Investigator:
          • Farhan Siddiqui
        • Contact:
      • Union, South Carolina, United States, 29379
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Joseph Boscia
        • Contact:
        • Contact:
    • Tennessee
      • Knoxville, Tennessee, United States, 37919
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Bashar Bargoty
    • Texas
      • Austin, Texas, United States, 78744
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Sean Gilbey
      • Dallas, Texas, United States, 75254
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Shakil Ahmed
      • El Paso, Texas, United States, 79902-1123
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Carlo Hatem
        • Contact:
        • Contact:
      • Houston, Texas, United States, 77094
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Murtuza Ahmed
      • Lampasas, Texas, United States, 76550
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Vanna Gold
      • Richmond, Texas, United States, 77407
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Samira Khan
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Danielle Coulter
      • Webster, Texas, United States, 77598
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Regina Pillai
        • Contact:
        • Contact:
    • West Virginia
      • Morgantown, West Virginia, United States, 26505-0423
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ward Paine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Participants will be administered placebo along with SoC.
Placebo as a sterile 0.9 percent (%) sodium chloride solution will be administered
Experimental: Depemokimab
Participants will be administered subcutaneous (SC) injection of Depemokimab along with standard of care (SoC).
Depemokimab as a sterile liquid formulation will be administered.
Other Names:
  • GSK3511294

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Annualized Rate of Moderate/Severe Exacerbations
Time Frame: From Baseline up to Week 104
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.
From Baseline up to Week 104

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to First Moderate/Severe Exacerbation
Time Frame: From Baseline up to Week 104
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.
From Baseline up to Week 104
Annualized Rate of Exacerbations Requiring Emergency Department (ED) Visit or Hospitalization
Time Frame: From Baseline up to Week 104
Annualized rate of exacerbations requiring ED Visit or Hospitalization (For pooled analysis across studies 222714 and 222725) will be assessed.
From Baseline up to Week 104
Annualized Rate of Severe Exacerbations
Time Frame: From Baseline up to Week 104
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.
From Baseline up to Week 104
Change from Baseline in St. George's Respiratory Questionnaire (SGRQ) Total Score at Week 52
Time Frame: From Baseline up to 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.
From Baseline up to Week 52
Change from Baseline in Evaluating Respiratory Symptoms in Chronic Obstructive Pulmonary Disease (E-RS: COPD) Total Score at Week 52
Time Frame: From Baseline up to 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.
From Baseline up to Week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Study Director: GSK Clinical Trials, GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 23, 2025

Primary Completion (Estimated)

August 21, 2029

Study Completion (Estimated)

August 21, 2029

Study Registration Dates

First Submitted

April 29, 2025

First Submitted That Met QC Criteria

April 29, 2025

First Posted (Actual)

May 7, 2025

Study Record Updates

Last Update Posted (Actual)

April 9, 2026

Last Update Submitted That Met QC Criteria

April 6, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/About_GSK_Patient_Level_Data_Sharing_Final_13July2023.pdf

IPD Sharing Time Frame

Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or asset(s) with development terminated across all indications.

IPD Sharing Access Criteria

Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months, but an extension may be granted, when justified, for up to 6 months.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pulmonary Disease, Chronic Obstructive

Clinical Trials on Depemokimab

Subscribe