A Study of GSK3511294 (Depemokimab) Compared With Mepolizumab or Benralizumab in Participants With Severe Asthma With an Eosinophilic Phenotype (NIMBLE)

October 14, 2025 updated by: GlaxoSmithKline

A 52-week, Randomised, Double-blind, Double-dummy, Parallel Group, Multi-centre, Non-inferiority Study Assessing Exacerbation Rate, Additional Measures of Asthma Control and Safety in Adult and Adolescent Severe Asthmatic Participants With an Eosinophilic Phenotype Treated With GSK3511294 Compared With Mepolizumab or Benralizumab

This study will assess whether switching participants who have benefitted from mepolizumab or benralizumab to GSK3511294 (Depemokimab) is non-inferior to maintaining current treatment on the annualized rate of clinically significant exacerbations in participants with severe asthma with an eosinophilic phenotype. Throughout the study, all participants will continue their non-biologic Baseline standard of care (SoC) asthma treatment.

Study Overview

Status

Completed

Conditions

Asthma

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1719

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 Locations

Australia
- New South Wales
  - Macquarie Park, New South Wales, Australia, 2109
    - GSK Investigational Site
  - Sydney, New South Wales, Australia, 2010
    - GSK Investigational Site
  - Westmead, New South Wales, Australia, 2145
    - GSK Investigational Site
- Queensland
  - Cairns, Queensland, Australia, 4870
    - GSK Investigational Site
  - South Brisbane, Queensland, Australia, 4101
    - GSK Investigational Site
- South Australia
  - Adelaide, South Australia, Australia, 5000
    - GSK Investigational Site
  - Bedford Park, South Australia, Australia, 5042
    - GSK Investigational Site
  - North Adelaide, South Australia, Australia, 5006
    - GSK Investigational Site
  - Toorak Gardens, South Australia, Australia, 5065
    - GSK Investigational Site
  - Woodville, South Australia, Australia, 5011
    - GSK Investigational Site
- Victoria
  - Box Hill, Victoria, Australia, 3128
    - GSK Investigational Site
  - Clayton, Victoria, Australia, 3168
    - GSK Investigational Site
  - Fitzroy, Victoria, Australia, 3065
    - GSK Investigational Site
  - Frankston, Victoria, Australia, 3199
    - GSK Investigational Site
  - Melbourne, Victoria, Australia, 3181
    - GSK Investigational Site
- Western Australia
  - Nedlands, Western Australia, Australia, 6009
    - GSK Investigational Site
Austria
- - Feldbach, Austria, 8330
    - GSK Investigational Site
  - Vienna, Austria, 1130
    - GSK Investigational Site
Canada
- Alberta
  - Calgary, Alberta, Canada, T2N 4Z6
    - GSK Investigational Site
  - Edmonton, Alberta, Canada, T5J 3S9
    - GSK Investigational Site
- New Brunswick
  - Moncton, New Brunswick, Canada, E1C 5K4
    - GSK Investigational Site
- Ontario
  - Ajax, Ontario, Canada, L1S 2J5
    - GSK Investigational Site
  - Ottawa, Ontario, Canada, K1H 1E4
    - GSK Investigational Site
  - Toronto, Ontario, Canada, M5G 1E2
    - GSK Investigational Site
  - Toronto, Ontario, Canada, M5T 3A9
    - GSK Investigational Site
  - Windsor, Ontario, Canada, N8X 1T3
    - GSK Investigational Site
- Quebec
  - Greenfield Park, Quebec, Canada, J4V 2H1
    - GSK Investigational Site
  - Québec, Quebec, Canada, G1V 4G5
    - GSK Investigational Site
  - Québec, Quebec, Canada, G1V 4W2
    - GSK Investigational Site
  - Trois-Rivières, Quebec, Canada, G8T 7A1
    - GSK Investigational Site
Finland
- - Tampere, Finland, 33520
    - GSK Investigational Site
  - Turku, Finland, 20521
    - GSK Investigational Site
France
- - Amiens, France, 80000
    - GSK Investigational Site
  - Annecy, France, 74011
    - GSK Investigational Site
  - Antony, France, 92160
    - GSK Investigational Site
  - Besançon, France, 25030
    - GSK Investigational Site
  - Brest, France, 29609
    - GSK Investigational Site
  - Caen, France, 14033
    - GSK Investigational Site
  - Cannes, France, 06414
    - GSK Investigational Site
  - Cholet, France, 49300
    - GSK Investigational Site
  - Dijon, France, 21079
    - GSK Investigational Site
  - La Tronche, France, 38700
    - GSK Investigational Site
  - Le Mans, France, 72037
    - GSK Investigational Site
  - Lille, France, 59037
    - GSK Investigational Site
  - Lyon, France, 69317
    - GSK Investigational Site
  - Marseille, France, 13015
    - GSK Investigational Site
  - Marseille, France, 13003.
    - GSK Investigational Site
  - Montfermeil, France, 93370
    - GSK Investigational Site
  - Montivilliers, France, 76290
    - GSK Investigational Site
  - Montpellier, France, 34295
    - GSK Investigational Site
  - Nice, France, 06001
    - GSK Investigational Site
  - Paris, France, 75015
    - GSK Investigational Site
  - Paris, France, 75014
    - GSK Investigational Site
  - Paris, France, 75877
    - GSK Investigational Site
  - Pontoise, France, 95303
    - GSK Investigational Site
  - Rouen, France, 76031
    - GSK Investigational Site
  - Saint-Herblain, France, 44093
    - GSK Investigational Site
  - Strasbourg, France, 67091
    - GSK Investigational Site
  - Suresnes, France, 92150
    - GSK Investigational Site
  - Toulouse, France, 31059
    - GSK Investigational Site
  - Tours, France, 37044
    - GSK Investigational Site
Germany
- - Aschaffenburg, Germany, 63739
    - GSK Investigational Site
  - Bendorf, Germany, 56170
    - GSK Investigational Site
  - Berlin, Germany, 10969
    - GSK Investigational Site
  - Berlin, Germany, 12203
    - GSK Investigational Site
  - Berlin, Germany, 12159
    - GSK Investigational Site
  - Bonn, Germany, 53127
    - GSK Investigational Site
  - Bonn, Germany, 53119
    - GSK Investigational Site
  - Darmstadt, Germany, 64283
    - GSK Investigational Site
  - Frankfurt, Germany, 60596
    - GSK Investigational Site
  - Frankfurt, Germany, 60389
    - GSK Investigational Site
  - Fürstenwalde, Germany, 15517
    - GSK Investigational Site
  - Geesthacht, Germany, 21502
    - GSK Investigational Site
  - Halle, Germany, 06120
    - GSK Investigational Site
  - Halle, Germany, 06108
    - GSK Investigational Site
  - Hamburg, Germany, 20354
    - GSK Investigational Site
  - Hanover, Germany, 30625
    - GSK Investigational Site
  - Landsberg, Germany, 86899
    - GSK Investigational Site
  - Leipzig, Germany, 04207
    - GSK Investigational Site
  - Leipzig, Germany, 04275
    - GSK Investigational Site
  - Leipzig, Germany, 04347
    - GSK Investigational Site
  - Lübeck, Germany, 23552
    - GSK Investigational Site
  - Lübeck, Germany, 23558
    - GSK Investigational Site
  - Magdeburg, Germany, 39120
    - GSK Investigational Site
  - Mainz, Germany, 55128
    - GSK Investigational Site
  - München, Germany, 81241
    - GSK Investigational Site
  - Neu-Isenburg, Germany, 63263
    - GSK Investigational Site
  - Rheine, Germany, 48431
    - GSK Investigational Site
  - Schleswig, Germany, 24837
    - GSK Investigational Site
Ireland
- - Cork, Ireland, T12 DFK4
    - GSK Investigational Site
  - Dublin, Ireland, D04 T6F4
    - GSK Investigational Site
  - Dublin, Ireland, D08 NHY1
    - GSK Investigational Site
Israel
- - Beersheba, Israel, 8410101
    - GSK Investigational Site
  - Haifa, Israel, 34362
    - GSK Investigational Site
  - Jerusalem, Israel, 91031
    - GSK Investigational Site
  - Jerusalem, Israel, 91120
    - GSK Investigational Site
  - Kfar Saba, Israel, 44281
    - GSK Investigational Site
  - Petah Tikva, Israel, 49100
    - GSK Investigational Site
  - Ramat Gan, Israel, 52621
    - GSK Investigational Site
  - Tel Aviv, Israel, 64239
    - GSK Investigational Site
  - Zrifin, Israel, 70300
    - GSK Investigational Site
Italy
- - Bari, Italy, 70124
    - GSK Investigational Site
  - Bergamo, Italy, 24127
    - GSK Investigational Site
  - Bologna, Italy, 40138
    - GSK Investigational Site
  - Brescia, Italy, 25123
    - GSK Investigational Site
  - Catania, Italy, 95123
    - GSK Investigational Site
  - Ferrara, Italy, 44124
    - GSK Investigational Site
  - Florence, Italy, 50134
    - GSK Investigational Site
  - Genova, Italy, 16132
    - GSK Investigational Site
  - Mantova, Italy, 46100
    - GSK Investigational Site
  - Milan, Italy, 20132
    - GSK Investigational Site
  - Milan, Italy, 20122
    - GSK Investigational Site
  - Milan, Italy, 20123
    - GSK Investigational Site
  - Milan, Italy, 20162
    - GSK Investigational Site
  - Modena, Italy, 41124
    - GSK Investigational Site
  - Monserrato CA, Italy, 09042
    - GSK Investigational Site
  - Napoli, Italy, 80131
    - GSK Investigational Site
  - Padua, Italy, 35128
    - GSK Investigational Site
  - Palermo, Italy, 90127
    - GSK Investigational Site
  - Pavia, Italy, 27100
    - GSK Investigational Site
  - Perugia, Italy, 06156
    - GSK Investigational Site
  - Pisa, Italy, 56100
    - GSK Investigational Site
  - Reggio Emilia, Italy, 42100
    - GSK Investigational Site
  - Roma, Italy, 168
    - GSK Investigational Site
  - Salerno, Italy, 84131
    - GSK Investigational Site
  - Sassari, Italy, 7100
    - GSK Investigational Site
  - Siena, Italy, 53100
    - GSK Investigational Site
  - Torino, Italy, 10128
    - GSK Investigational Site
  - Torrette AN, Italy, 60020
    - GSK Investigational Site
  - Treviso, Italy, 31100
    - GSK Investigational Site
  - Trieste, Italy, 34139
    - GSK Investigational Site
  - Verona, Italy, 37134
    - GSK Investigational Site
Japan
- - Aichi, Japan, 470-1192
    - GSK Investigational Site
  - Aichi, Japan, 489-8642
    - GSK Investigational Site
  - Aichi, Japan, 454-8509
    - GSK Investigational Site
  - Akita, Japan, 010-8543
    - GSK Investigational Site
  - Ehime, Japan, 790-0024
    - GSK Investigational Site
  - Fukuoka, Japan, 802-0052
    - GSK Investigational Site
  - Fukuoka, Japan, 811-1394
    - GSK Investigational Site
  - Fukuoka, Japan, 806-8501
    - GSK Investigational Site
  - Fukuoka, Japan, 813-0017
    - GSK Investigational Site
  - Fukuoka, Japan, 830-0011
    - GSK Investigational Site
  - Fukuoka, Japan, 805-8508
    - GSK Investigational Site
  - Fukushima, Japan, 960-1295
    - GSK Investigational Site
  - Gifu, Japan, 509-6134
    - GSK Investigational Site
  - Hiroshima, Japan, 737-0023
    - GSK Investigational Site
  - Hiroshima, Japan, 734-8530
    - GSK Investigational Site
  - Hiroshima, Japan, 735-8585
    - GSK Investigational Site
  - Hokkaido, Japan, 064-0804
    - GSK Investigational Site
  - Hyōgo, Japan, 650-0047
    - GSK Investigational Site
  - Hyōgo, Japan, 653-0013
    - GSK Investigational Site
  - Ibaraki, Japan, 319-1113
    - GSK Investigational Site
  - Ibaraki, Japan, 302-0022
    - GSK Investigational Site
  - Ishikawa, Japan, 920-0293
    - GSK Investigational Site
  - Kagawa, Japan, 762-8550
    - GSK Investigational Site
  - Kagoshima, Japan, 890-8520
    - GSK Investigational Site
  - Kanagawa, Japan, 236-0004
    - GSK Investigational Site
  - Kanagawa, Japan, 232-0024
    - GSK Investigational Site
  - Kanagawa, Japan, 231-8682
    - GSK Investigational Site
  - Kanagawa, Japan, 254-8502
    - GSK Investigational Site
  - Kanagawa, Japan, 236-0051
    - GSK Investigational Site
  - Mie, Japan, 511-0061
    - GSK Investigational Site
  - Mie, Japan, 515-8544
    - GSK Investigational Site
  - Mie, Japan, 510-8561
    - GSK Investigational Site
  - Miyagi, Japan, 981-8563
    - GSK Investigational Site
  - Nagano, Japan, 386-8610
    - GSK Investigational Site
  - Niigata, Japan, 951-8520
    - GSK Investigational Site
  - Numakunai, Japan, 020-8505
    - GSK Investigational Site
  - Okayama, Japan, 701-0304
    - GSK Investigational Site
  - Okayama, Japan, 702-8055
    - GSK Investigational Site
  - Osaka, Japan, 596-8501
    - GSK Investigational Site
  - Osaka, Japan, 530-0012
    - GSK Investigational Site
  - Osaka, Japan, 569-8686
    - GSK Investigational Site
  - Osaka, Japan, 593-8304
    - GSK Investigational Site
  - Osaka, Japan, 560-8552
    - GSK Investigational Site
  - Osaka, Japan, 543-8555
    - GSK Investigational Site
  - Osaka, Japan, 569-1192
    - GSK Investigational Site
  - Osaka, Japan, 569-1096
    - GSK Investigational Site
  - Osaka, Japan, 572-8551
    - GSK Investigational Site
  - Shimane, Japan, 693-8501
    - GSK Investigational Site
  - Shizuoka, Japan, 430-8525
    - GSK Investigational Site
  - Shizuoka, Japan, 420-8527
    - GSK Investigational Site
  - Tokyo, Japan, 103-0027
    - GSK Investigational Site
  - Tokyo, Japan, 160-8582
    - GSK Investigational Site
  - Tokyo, Japan, 142-8666
    - GSK Investigational Site
  - Tokyo, Japan, 162-8655
    - GSK Investigational Site
  - Tokyo, Japan, 113-8431
    - GSK Investigational Site
  - Tokyo, Japan, 136-0075
    - GSK Investigational Site
  - Tokyo, Japan, 141-8625
    - GSK Investigational Site
  - Tokyo, Japan, 113-8519
    - GSK Investigational Site
  - Tokyo, Japan, 204-8585
    - GSK Investigational Site
  - Tokyo, Japan, 173-8606
    - GSK Investigational Site
  - Tokyo, Japan, 190-0014
    - GSK Investigational Site
  - Tokyo, Japan, 105-8471
    - GSK Investigational Site
  - Tokyo, Japan, 187-8510
    - GSK Investigational Site
  - Toyama, Japan, 930-8550
    - GSK Investigational Site
  - Wakayama, Japan, 640-8558
    - GSK Investigational Site
- Tokyo
  - Shibuya-Ku, Tokyo, Japan, 150-8935
    - GSK Investigational Site
Netherlands
- - Arnhem, Netherlands, 6815 AD
    - GSK Investigational Site
  - Breda, Netherlands, 4818 CK
    - GSK Investigational Site
  - Deventer, Netherlands, 7416 SE
    - GSK Investigational Site
  - Eindhoven, Netherlands, 5623 EJ
    - GSK Investigational Site
  - Enschede, Netherlands, 7513 ER
    - GSK Investigational Site
  - Harderwijk, Netherlands, 3844 DG
    - GSK Investigational Site
  - Leeuwarden, Netherlands, 8934 AD
    - GSK Investigational Site
  - Nijmegen, Netherlands, 6532 SZ
    - GSK Investigational Site
  - Rotterdam, Netherlands, 3045 PM
    - GSK Investigational Site
  - Zwolle, Netherlands, 8025 AB
    - GSK Investigational Site
Norway
- - Bergen, Norway, 5021
    - GSK Investigational Site
  - Lrenskog, Norway, 1478
    - GSK Investigational Site
Portugal
- - Coimbra, Portugal, 3041-801
    - GSK Investigational Site
  - Guarda, Portugal, 6300-035
    - GSK Investigational Site
  - Lisbon, Portugal, 1649-035
    - GSK Investigational Site
  - Matosinhos Municipality, Portugal, 4464-509
    - GSK Investigational Site
Puerto Rico
- - Guaynabo, Puerto Rico, 00968
    - GSK Investigational Site
Slovenia
- - Golnik, Slovenia, 4204
    - GSK Investigational Site
Spain
- - Alcorcón, Spain, 28922
    - GSK Investigational Site
  - Almería, Spain, 04009
    - GSK Investigational Site
  - Badalona, Spain, 08916
    - GSK Investigational Site
  - Barcelona, Spain, 08036
    - GSK Investigational Site
  - Barcelona, Spain, 08035
    - GSK Investigational Site
  - Barcelona, Spain, 08003
    - GSK Investigational Site
  - Barcelona, Spain, 8025
    - GSK Investigational Site
  - Barcelona, Spain, 08950
    - GSK Investigational Site
  - Barcelona, Spain, 08017
    - GSK Investigational Site
  - Benalmádena, Spain, 29631
    - GSK Investigational Site
  - Bilbao, Spain, 48013
    - GSK Investigational Site
  - Granada, Spain, 18014
    - GSK Investigational Site
  - Jerez de la Frontera, Spain, 11407
    - GSK Investigational Site
  - La Laguna Santa Cruz, Spain, 38320
    - GSK Investigational Site
  - MErida Badajoz, Spain, 06800
    - GSK Investigational Site
  - Madrid, Spain, 28041
    - GSK Investigational Site
  - Madrid, Spain, 28040
    - GSK Investigational Site
  - Madrid, Spain, 28046
    - GSK Investigational Site
  - Madrid, Spain, 28031
    - GSK Investigational Site
  - Málaga, Spain, 29010
    - GSK Investigational Site
  - Pamplona, Spain, 31008
    - GSK Investigational Site
  - Pozuelo de AlarcOn Madr, Spain, 28223
    - GSK Investigational Site
  - Salamanca, Spain, 37007
    - GSK Investigational Site
  - Santander, Spain, 39008
    - GSK Investigational Site
  - Santiago de Compostela, Spain, 15706
    - GSK Investigational Site
  - Valencia, Spain, 46017
    - GSK Investigational Site
  - Valencia, Spain, 46015
    - GSK Investigational Site
  - Via-Real CastellOn, Spain, 12540
    - GSK Investigational Site
  - Vitoria-Gasteiz, Spain, 01009
    - GSK Investigational Site
  - Zaragoza, Spain, 50009
    - GSK Investigational Site
Sweden
- - Linköping, Sweden, SE-58758
    - GSK Investigational Site
  - Lund, Sweden, SE-221 85
    - GSK Investigational Site
  - Stockholm, Sweden, SE-141 86
    - GSK Investigational Site
  - Uppsala, Sweden, SE-751 85
    - GSK Investigational Site
  - Östersund, Sweden, SE-831 83
    - GSK Investigational Site
Switzerland
- - Aarau, Switzerland, 5001
    - GSK Investigational Site
  - Basel, Switzerland, 4031
    - GSK Investigational Site
  - Liestal, Switzerland, 4410
    - GSK Investigational Site
  - Sankt Gallen, Switzerland, 9007
    - GSK Investigational Site
Taiwan
- - Banchiau Taipei, Taiwan, 220
    - GSK Investigational Site
  - Changhua, Taiwan, 500
    - GSK Investigational Site
  - Linkou - Taoyuan Hsien, Taiwan, 333
    - GSK Investigational Site
  - Taichung, Taiwan, 404
    - GSK Investigational Site
  - Taichung, Taiwan, 40705
    - GSK Investigational Site
  - Taipei, Taiwan, 100
    - GSK Investigational Site
United Kingdom
- - Belfast, United Kingdom, BT9 7AB
    - GSK Investigational Site
  - Birmingham, United Kingdom, B9 5SS
    - GSK Investigational Site
  - Bradford, United Kingdom, BD9 6RJ
    - GSK Investigational Site
  - Bristol Avon, United Kingdom, BS10 5NB
    - GSK Investigational Site
  - Cottingham, United Kingdom, HU16 5JQ
    - GSK Investigational Site
  - Exeter, United Kingdom, EX2 5DW
    - GSK Investigational Site
  - Glasgow, United Kingdom, G31 2ER
    - GSK Investigational Site
  - Glasgow, United Kingdom, G51 4TF
    - GSK Investigational Site
  - Liverpool, United Kingdom, L7 8XP
    - GSK Investigational Site
  - London, United Kingdom, EC1A 7BE
    - GSK Investigational Site
  - Newcastle upon Tyne, United Kingdom, NE7 7DN
    - GSK Investigational Site
  - Nottingham, United Kingdom, NG5 1PB
    - GSK Investigational Site
  - Oxford, United Kingdom, OX3 9DU
    - GSK Investigational Site
  - Portsmouth, United Kingdom, PO6 3LY
    - GSK Investigational Site
  - Preston, United Kingdom, PR2 9HT
    - GSK Investigational Site
  - Wakefield, United Kingdom, WF1 4DG
    - GSK Investigational Site
  - Wishaw, United Kingdom, ML6 0JS
    - GSK Investigational Site
United States
- Alabama
  - Birmingham, Alabama, United States, 35209
    - GSK Investigational Site
  - Scottsboro, Alabama, United States, 35768
    - GSK Investigational Site
- Arizona
  - Litchfield Park, Arizona, United States, 85340
    - GSK Investigational Site
  - Phoenix, Arizona, United States, 85054
    - GSK Investigational Site
  - Scottsdale, Arizona, United States, 85251
    - GSK Investigational Site
- California
  - Bakersfield, California, United States, 93301
    - GSK Investigational Site
  - Encinitas, California, United States, 92024
    - GSK Investigational Site
  - Huntington Beach, California, United States, 92647
    - GSK Investigational Site
  - Los Angeles, California, United States, 90048
    - GSK Investigational Site
  - Newport Beach, California, United States, 92663
    - GSK Investigational Site
  - Oxnard, California, United States, 93036
    - GSK Investigational Site
  - Rancho Cucamonga, California, United States, 91730
    - GSK Investigational Site
  - Redondo Beach, California, United States, 90277
    - GSK Investigational Site
  - Redwood City, California, United States, 94063
    - GSK Investigational Site
  - Riverside, California, United States, 91786
    - GSK Investigational Site
  - San Diego, California, United States, 92123
    - GSK Investigational Site
  - San Diego, California, United States, 92307
    - GSK Investigational Site
  - Valencia, California, United States, 91324
    - GSK Investigational Site
  - Woodland, California, United States, 95695
    - GSK Investigational Site
- Colorado
  - Aurora, Colorado, United States, 80238
    - GSK Investigational Site
  - Colorado Springs, Colorado, United States, 80907
    - GSK Investigational Site
  - Colorado Springs, Colorado, United States, 80923
    - GSK Investigational Site
  - Denver, Colorado, United States, 80209
    - GSK Investigational Site
  - Wheat Ridge, Colorado, United States, 80033
    - GSK Investigational Site
- Connecticut
  - New Haven, Connecticut, United States, 06511
    - GSK Investigational Site
- Florida
  - Aventura, Florida, United States, 33180
    - GSK Investigational Site
  - Clearwater, Florida, United States, 33765-2103
    - GSK Investigational Site
  - Fort Lauderdale, Florida, United States, 33316
    - GSK Investigational Site
  - Gainesville, Florida, United States, 32610
    - GSK Investigational Site
  - Hialeah, Florida, United States, 33016
    - GSK Investigational Site
  - Hialeah, Florida, United States, 33014
    - GSK Investigational Site
  - Jacksonville, Florida, United States, 32209
    - GSK Investigational Site
  - Kissimmee, Florida, United States, 34746
    - GSK Investigational Site
  - Loxahatchee Groves, Florida, United States, 33470
    - GSK Investigational Site
  - Miami, Florida, United States, 33125
    - GSK Investigational Site
  - Miami, Florida, United States, 33126
    - GSK Investigational Site
  - Miami, Florida, United States, 33144
    - GSK Investigational Site
  - Miami, Florida, United States, 33186
    - GSK Investigational Site
  - Miami, Florida, United States, 33166
    - GSK Investigational Site
  - Miami, Florida, United States, 33172
    - GSK Investigational Site
  - Miami Lakes, Florida, United States, 33014
    - GSK Investigational Site
  - Miami Lakes, Florida, United States, 33125
    - GSK Investigational Site
  - North Palm Beach, Florida, United States, 33408
    - GSK Investigational Site
  - Orlando, Florida, United States, 32803
    - GSK Investigational Site
  - Orlando, Florida, United States, 32806
    - GSK Investigational Site
  - Orlando, Florida, United States, 32819
    - GSK Investigational Site
  - Sebring, Florida, United States, 33870
    - GSK Investigational Site
  - Tallahassee, Florida, United States, 32308
    - GSK Investigational Site
- Georgia
  - Calhoun, Georgia, United States, 30701
    - GSK Investigational Site
- Illinois
  - Glenview, Illinois, United States, 60077
    - GSK Investigational Site
- Indiana
  - Evansville, Indiana, United States, 47715
    - GSK Investigational Site
- Kansas
  - Overland Park, Kansas, United States, 66210
    - GSK Investigational Site
- Kentucky
  - Lexington, Kentucky, United States, 40509
    - GSK Investigational Site
  - Owensboro, Kentucky, United States, 42301
    - GSK Investigational Site
- Maine
  - Bangor, Maine, United States, 04401
    - GSK Investigational Site
- Maryland
  - Baltimore, Maryland, United States, 21224
    - GSK Investigational Site
  - Baltimore, Maryland, United States, 21162
    - GSK Investigational Site
  - Chevy Chase, Maryland, United States, 20815
    - GSK Investigational Site
- Massachusetts
  - Boston, Massachusetts, United States, 02115
    - GSK Investigational Site
  - Burlington, Massachusetts, United States, 01805
    - GSK Investigational Site
  - New Bedford, Massachusetts, United States, 02740
    - GSK Investigational Site
  - North Dartmouth, Massachusetts, United States, 02747
    - GSK Investigational Site
- Michigan
  - Ann Arbor, Michigan, United States, 48109
    - GSK Investigational Site
  - Flint, Michigan, United States, 48507
    - GSK Investigational Site
  - Warren, Michigan, United States, 48088
    - GSK Investigational Site
- Minnesota
  - Minneapolis, Minnesota, United States, 55454
    - GSK Investigational Site
- Mississippi
  - Gulfport, Mississippi, United States, 36608
    - GSK Investigational Site
  - Jackson, Mississippi, United States, 39216
    - GSK Investigational Site
- Missouri
  - Chesterfield, Missouri, United States, 63017
    - GSK Investigational Site
  - Saint Charles, Missouri, United States, 63301
    - GSK Investigational Site
  - St Louis, Missouri, United States, 63110
    - GSK Investigational Site
- Nebraska
  - Lincoln, Nebraska, United States, 68505
    - GSK Investigational Site
  - Omaha, Nebraska, United States, 68198-5990
    - GSK Investigational Site
- New Jersey
  - Brick, New Jersey, United States, 08724
    - GSK Investigational Site
  - Northfield, New Jersey, United States, 08225
    - GSK Investigational Site
  - Riverdale, New Jersey, United States, 07457
    - GSK Investigational Site
  - Toms River, New Jersey, United States, 08755
    - GSK Investigational Site
- New York
  - Brooklyn, New York, United States, 11215
    - GSK Investigational Site
  - Corning, New York, United States, 14845
    - GSK Investigational Site
  - Great Neck, New York, United States, 11040
    - GSK Investigational Site
  - New York, New York, United States, 60301
    - GSK Investigational Site
  - The Bronx, New York, United States, 10467
    - GSK Investigational Site
  - The Bronx, New York, United States, 10459-2417
    - GSK Investigational Site
- North Carolina
  - Asheville, North Carolina, United States, 28803
    - GSK Investigational Site
  - Huntersville, North Carolina, United States, 28078
    - GSK Investigational Site
  - Wilmington, North Carolina, United States, 28401
    - GSK Investigational Site
  - Winston-Salem, North Carolina, United States, 27157
    - GSK Investigational Site
  - Winston-Salem, North Carolina, United States, 27103
    - GSK Investigational Site
- Ohio
  - Cincinnati, Ohio, United States, 45231
    - GSK Investigational Site
  - Cincinnati, Ohio, United States, 45229
    - GSK Investigational Site
- Oregon
  - Corvallis, Oregon, United States, 97330
    - GSK Investigational Site
- Pennsylvania
  - Altoona, Pennsylvania, United States, 16601
    - GSK Investigational Site
  - Altoona, Pennsylvania, United States, 15801
    - GSK Investigational Site
  - Hershey, Pennsylvania, United States, 17033
    - GSK Investigational Site
  - Philadelphia, Pennsylvania, United States, 19140
    - GSK Investigational Site
  - Pittsburgh, Pennsylvania, United States, 15241
    - GSK Investigational Site
  - Wyomissing, Pennsylvania, United States, 19610
    - GSK Investigational Site
- Rhode Island
  - Warwick, Rhode Island, United States, 02886
    - GSK Investigational Site
- South Carolina
  - Rock Hill, South Carolina, United States, 29732
    - GSK Investigational Site
  - Spartanburg, South Carolina, United States, 29303
    - GSK Investigational Site
- Tennessee
  - Hendersonville, Tennessee, United States, 37075
    - GSK Investigational Site
  - Knoxville, Tennessee, United States, 37909
    - GSK Investigational Site
- Texas
  - Amarillo, Texas, United States, 79106
    - GSK Investigational Site
  - Amarillo, Texas, United States, 79124
    - GSK Investigational Site
  - Dallas, Texas, United States, 75246
    - GSK Investigational Site
  - Dallas, Texas, United States, 75235
    - GSK Investigational Site
  - Dallas, Texas, United States, 75225
    - GSK Investigational Site
  - Houston, Texas, United States, 77030
    - GSK Investigational Site
  - Houston, Texas, United States, 77429
    - GSK Investigational Site
  - Kerrville, Texas, United States, 78028
    - GSK Investigational Site
  - San Antonio, Texas, United States, 78229
    - GSK Investigational Site
  - San Antonio, Texas, United States, 78258
    - GSK Investigational Site
  - San Antonio, Texas, United States, 78207
    - GSK Investigational Site
- Utah
  - Murray, Utah, United States, 84107
    - GSK Investigational Site
- Virginia
  - Richmond, Virginia, United States, 23298
    - GSK Investigational Site
  - Williamsburg, Virginia, United States, 23188
    - GSK Investigational Site
- Washington
  - Bellingham, Washington, United States, 98225
    - GSK Investigational Site
  - Seattle, Washington, United States, 98115
    - GSK Investigational Site
- Wisconsin
  - Greenfield, Wisconsin, United States, 53228
    - GSK Investigational Site

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

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Description

Key inclusion criteria for study:

Adult and adolescent participants more than or equal to (>=)12 years of age, at the time of signing the informed consent/assent.
Participants who have a documented physician diagnosis of asthma for >=2 years that meets the National Heart, Lung, and Blood Institute guidelines (NHLBI) or Global Initiative for Asthma (GINA) guidelines.
Participants receiving either mepolizumab 100 milligrams (mg) or benralizumab 30 mg for >=12 months prior to screening and have a documented benefit to therapy assessed by either:
(i) >=50% reduction in exacerbation frequency since initiating treatment, or (ii) >=50% reduction in maintenance OCS use since initiating treatment, or (iii) No exacerbations in the past 6 months whilst receiving anti-IL-5/5R therapy and an Asthma Control Questionnaire (ACQ)-5 score of less than or equal to (<=)1.5 at screening.
A well-documented requirement for regular treatment with medium to high dose ICS in the 12 months prior to Visit 1 with or without maintenance OCS. The maintenance ICS dose must be >=440 micrograms (mcg) fluticasone propionate (FP) hydrofluoroalkane (HFA) product daily, or clinically comparable. Participants who are treated with medium dose ICS will also need to be treated with a LABA to qualify for inclusion.
Current treatment with at least one additional controller medication, besides ICS [for example (e.g.), LABA, LAMA, leukotriene receptor antagonist (LTRA), or theophylline].

Key exclusion criteria for study:

Participants with presence of a known pre-existing, clinically important lung condition other than asthma. This includes (but is not limited to) current infection, bronchiectasis, pulmonary fibrosis, bronchopulmonary aspergillosis, or diagnoses of emphysema or chronic bronchitis (chronic obstructive pulmonary disease other than asthma) or a history of lung cancer.
Participants with other conditions that could lead to elevated eosinophils such as hyper-eosinophilic syndromes including (but not limited to) Eosinophilic Granulomatosis with Polyangiitis (EGPA, formerly known as Churg-Strauss Syndrome) or Eosinophilic Esophagitis.
A current malignancy or previous history of cancer in remission for less than 12 months prior to screening (Participants that had localized carcinoma of the skin which was resected for cure will not be excluded).
Cirrhosis or current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice.
Participants with current diagnosis of vasculitis. Participants with high clinical suspicion of vasculitis at screening will be evaluated and current vasculitis excluded prior to enrolment.
Participants who have received Omalizumab (Xolair), dupilumab (Dupixent) or reslizumab (Cinqair/Cinqaero) within 130 days prior to Visit 1.
Participants who have received any Monoclonal antibody (mAb) within 5 half-lives of Visit 1.
Corrected QT interval using Fridericia's formula (QTcF) >=450 milliseconds (msec) or QTcF >=480 msec for participants with Bundle Branch Block at screening Visit 1.
Current smokers or former smokers with a smoking history of >=10 pack years (number of pack years equal to [number of cigarettes per day/20] times number of years smoked). A former smoker is defined as a participant who quit smoking at least 6 months prior to Visit 1.
Participants with allergy/intolerance to a mAb or biologic.

Key exclusion criteria for randomization:

Evidence of a clinically significant abnormality in the 12-lead electrocardiogram (ECG) over-read conducted at Screening Visit 1, based on the evaluation of the investigator, or QTcF >=450 msec or QTcF >=480 msec for participants with Bundle Branch Block, at randomization Visit 2.
Participants with a clinically significant asthma exacerbation in the 7 days prior to randomization should have their randomization visit delayed until the investigator considers the participant's asthma to be stable. If the 8-week screening period has elapsed, then the participant should be considered a run-in failure.
Any changes in the dose or regimen of Baseline ICS and/or additional controller medication (except for treatment of an exacerbation) during the run-in period.

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: Double

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Participants receiving GSK3511294 (Depemokimab) plus placebo matching prior anti-IL-5/5R treatment Participants will receive GSK3511294 (Depemokimab) plus placebo treatment matching the active comparator (participant's anti-Interleukin-5/ 5 receptor [anti-IL-5/5R] treatment prior to randomization): either placebo matching mepolizumab or placebo matching benralizumab. All participants will continue their non-biologic Baseline SoC asthma treatment throughout the study.	Biological: GSK3511294 (Depemokimab) GSK3511294 (Depemokimab) will be provided in a single-use prefilled syringe (PFS). Biological: Placebo Placebo will be a sterile liquid formulation. Drug: Standard of care (SoC) Non-biologic SoC will include inhaled corticosteroid (ICS) plus at least one other controller, long-acting beta-2-agonist (LABA), long-acting muscarinic antagonist (LAMA), with or without maintenance oral corticosteroids (OCS). Device: Pre-filled Syringes (PFS) PFS will include glass barrel with pre-staked needle and plunger.
Active Comparator: Participants receiving prior anti-IL-5/5R treatment plus placebo matching GSK3511294 (Depemokimab) Participants will receive active comparator (participant's anti-IL-5/5R treatment prior to randomization): either mepolizumab or benralizumab, plus placebo matching GSK3511294 (Depemokimab). All participants will continue their non-biologic Baseline SoC asthma treatment throughout the study.	Biological: Placebo Placebo will be a sterile liquid formulation. Drug: Standard of care (SoC) Non-biologic SoC will include inhaled corticosteroid (ICS) plus at least one other controller, long-acting beta-2-agonist (LABA), long-acting muscarinic antagonist (LAMA), with or without maintenance oral corticosteroids (OCS). Device: Pre-filled Syringes (PFS) PFS will include glass barrel with pre-staked needle and plunger. Biological: Mepolizumab Mepolizumab will be provided in a single-use PFS. Biological: Benralizumab Benralizumab will be provided in a single-use PFS.

Participant Group / Arm

Intervention / Treatment

Experimental: Participants receiving GSK3511294 (Depemokimab) plus placebo matching prior anti-IL-5/5R treatment

Participants will receive GSK3511294 (Depemokimab) plus placebo treatment matching the active comparator (participant's anti-Interleukin-5/ 5 receptor [anti-IL-5/5R] treatment prior to randomization): either placebo matching mepolizumab or placebo matching benralizumab. All participants will continue their non-biologic Baseline SoC asthma treatment throughout the study.

Biological: GSK3511294 (Depemokimab)

GSK3511294 (Depemokimab) will be provided in a single-use prefilled syringe (PFS).

Biological: Placebo

Placebo will be a sterile liquid formulation.

Drug: Standard of care (SoC)

Non-biologic SoC will include inhaled corticosteroid (ICS) plus at least one other controller, long-acting beta-2-agonist (LABA), long-acting muscarinic antagonist (LAMA), with or without maintenance oral corticosteroids (OCS).

Device: Pre-filled Syringes (PFS)

PFS will include glass barrel with pre-staked needle and plunger.

Active Comparator: Participants receiving prior anti-IL-5/5R treatment plus placebo matching GSK3511294 (Depemokimab)

Participants will receive active comparator (participant's anti-IL-5/5R treatment prior to randomization): either mepolizumab or benralizumab, plus placebo matching GSK3511294 (Depemokimab). All participants will continue their non-biologic Baseline SoC asthma treatment throughout the study.

Biological: Placebo

Placebo will be a sterile liquid formulation.

Drug: Standard of care (SoC)

Device: Pre-filled Syringes (PFS)

PFS will include glass barrel with pre-staked needle and plunger.

Biological: Mepolizumab

Mepolizumab will be provided in a single-use PFS.

Biological: Benralizumab

Benralizumab will be provided in a single-use PFS.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Annualized rate of clinically significant exacerbations over 52 weeks Time Frame: Up to Week 52	Clinically significant exacerbations of asthma are defined by worsening of asthma which requires use of systemic corticosteroids and/or hospitalization and/or Emergency Department (ED) visit. Annualized rate of exacerbations will be calculated as number of exacerbations experienced by the participant divided by the length of time the participant is measured on.	Up to Week 52

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weighted mean change from Baseline in St. George's Respiratory Questionnaire (SGRQ) total score Time Frame: Baseline (Day 1) and up to Week 52	The SGRQ is a well-established instrument, comprising 51 questions designed to measure Quality of Life in participants with diseases of airway obstruction. Higher score indicates worse quality of life.	Baseline (Day 1) and up to Week 52
Weighted mean change from Baseline in Asthma Control Questionnaire-5 (ACQ-5) score Time Frame: Baseline (Day 1) and up to Week 52	The ACQ-5 is a five-item questionnaire, which has been developed as a measure of participants' asthma control that can be quickly and easily completed. The five questions enquire about the frequency and/or severity of symptoms (nocturnal awakening on waking in the morning, activity limitation, and shortness of breath, wheeze) over the previous week. The response options for all these questions consist of a zero (no impairment/limitation) to six (total impairment/ limitation) scale. Higher score indicates more limitations.	Baseline (Day 1) and up to Week 52
Weighted mean change from Baseline in pre-bronchodilator forced expiratory volume in one second (FEV1) Time Frame: Baseline (Day 1) and up to Week 52	FEV1 is a measure of pulmonary function and is the maximum amount of air that can be forced out in one second after taking a deep breath. FEV1 will be measured using spirometry.	Baseline (Day 1) and up to Week 52

Collaborators and Investigators

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

Sponsor

GlaxoSmithKline

Collaborators

IQVIA Pty Ltd

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)

January 26, 2021

Primary Completion (Actual)

September 14, 2025

Study Completion (Actual)

September 14, 2025

Study Registration Dates

First Submitted

January 18, 2021

First Submitted That Met QC Criteria

January 18, 2021

First Posted (Actual)

January 22, 2021

Study Record Updates

Last Update Posted (Estimated)

October 15, 2025

Last Update Submitted That Met QC Criteria

October 14, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

206785

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

IPD for this study will be made available via the Clinical Study Data Request site.

IPD Sharing Time Frame

IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.

IPD Sharing Access Criteria

Access is provided after a research proposal is submitted and has received approval from the 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 can be granted, when justified, for up to another 12 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

Yes

product manufactured in and exported from the U.S.

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.

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Study Overview

Status

Conditions

Intervention / Treatment

Study Type

Enrollment (Actual)

Phase

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Collaborators

Investigators

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Actual)

Study Completion (Actual)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Estimated)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

IPD Plan Description

IPD Sharing Time Frame

IPD Sharing Access Criteria

IPD Sharing Supporting Information Type

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

product manufactured in and exported from the U.S.

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Clinical Trials on GSK3511294 (Depemokimab)

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