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

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: Biological: Placebo; Drug: Standard of care (SoC); Device: Pre-filled Syringes (PFS); Biological: GSK3511294 (Depemokimab); Biological: Mepolizumab; Biological: Benralizumab

• Study Type: Interventional
• Enrollment (Actual): 1717
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Macquarie University, 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
  • Mantua, 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
  • Naples, Italy, 80131
    • GSK Investigational Site
  • Padova, 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

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Depemokimab 100mg SC; Participants received GSK3511294 (Depemokimab) 100 milligrams (mg) subcutaneous (SC) injection administered every 26 weeks (week 0 and week 26) alongside placebo SC treatment matching the active comparator (participant's anti-IL-5/5R treatment prior to randomisation: either placebo matching mepolizumab every 4 weeks or placebo matching benralizumab every 8 weeks).	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: GSK3511294 (Depemokimab); GSK3511294 (Depemokimab) 100 mg SC along with the placebo and SOC will be administered.
Active Comparator: Mepolizumab 100 mg / Benralizumab 30 mg SC; Participants received their existing active comparator (either mepolizumab 100 mg every 4 weeks or benralizumab 30 mg every 8 weeks) according to the participant's treatment prior to randomisation plus placebo SC matching GSK3511294 (Depemokimab) administered every 26 weeks.	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 100 mg SC will be administered in a single-use PFS.; Biological: Benralizumab; Benralizumab 30 mg will be administered 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	Clinically significant exacerbations recorded were defined as worsening of asthma requiring the use of systemic corticosteroids (CS) [such as intramuscular (IM), intravenous (IV) or oral] and/or hospitalization and/or Emergency Department (ED) visit. For all participants, IV or oral steroids (e.g., prednisone) for at least 3 days or a single IM corticosteroid dose is required. For participants on maintenance systemic corticosteroids, at least double the existing maintenance dose for at least 3 days is required. Exacerbations recorded in the electronic case report form (eCRF) were considered as verified clinically significant exacerbations and included in the primary analysis. Exacerbations separated by less than 7 days was treated as a continuation of the same exacerbation.	Up to Week 52

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weighted Mean (WM) Change From Baseline in St. George's Respiratory Questionnaire (SGRQ) Total Score	SGRQ: validated, disease specific questionnaire comprising of 51 questions designed to measure health related quality of life in participants with disease of airway obstruction. It assesses how respiratory symptoms and limitations affect daily life. SGRQ 3 domains: Symptoms, Activity and, Impacts. Each item has an empirically derived weight, and domain scores are combined to produce a total score ranging: 0 to 100. Scores are expressed as a percentage of overall impairment between 100 (worst possible health status) and 0 (best possible health status). Higher scores indicating greater impairment of quality of life. Change from Baseline (CFB): value at indicated time point minus Baseline value. For each participant, WM CFB in SGRQ total score was calculated using linear trapezoidal rule to estimate area under the curve (AUC) from Baseline (Day 1) across Weeks 4, 12, 26, and 52 and presented as a single consolidated SGRQ total score on original scale (i.e., not expressed per unit time).	From Baseline (Day 1) up to Week 52
Weighted Mean Change From Baseline in Asthma Control Questionnaire-5 (ACQ-5) Score	The ACQ 5 is a validated, 5-item patient reported tool assessing asthma symptoms over the past week. The 5 questions enquired to recall how their asthma had been during the previous week and to respond about the frequency and/or severity of symptoms (nocturnal awakening, waking in the morning, activity limitation, shortness of breath and wheezing). Each item is scored from 0 (no impairment) to 6 (maximum impairment), and the final ACQ 5 score is the average of all items, ranging from 0 to 6. Lower scores indicate better asthma control, while higher scores indicate poorer control. CFB was defined as value at the indicated time point minus Baseline value. For each participant, the WM CFB in ACQ-5 score was calculated using the linear trapezoidal rule to estimate the AUC from Baseline (Day 1) across Weeks 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 44, 48 and 52) and presented as a single consolidated ACQ-5 score on the original scale (i.e., not expressed per unit/time).	From Baseline (Day 1) up to Week 52
Weighted Mean Change From Baseline in Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1)	Forced Expiratory Volume in One Second (FEV1) is defined as the volume of air that can be forced out in one second after taking a deep breath by a person and was measured by spirometry testing. Change from Baseline in clinic pre-bronchodilator FEV1 was determined. Change from Baseline was defined as value at the indicated time point minus Baseline value. For each participant, the WM change from baseline in FEV1 was calculated using the linear trapezoidal rule to estimate the AUC from Baseline (Day 1) across Weeks 12, 26, 40, and 52). WM change from baseline in FEV1 over 52-week period was presented as a single consolidated data.	From Baseline (Day 1) up to Week 52

Collaborators and Investigators

• Sponsor: GlaxoSmithKline
• Collaborators: IQVIA Pty Ltd
• Investigators: Study Director: GSK Clinical Trials, GlaxoSmithKline

Publications and helpful links

General Publications

• Chupp G, Nagase H, Skowasch D, Devouassoux G, Cote A, Jackson DJ, Jackson DJ, Wechsler ME, Imber V, McGinniss JE, K SO, Howarth P, Pavord ID; NIMBLE Study Investigators. Switching to twice-yearly depemokimab from mepolizumab/benralizumab in severe asthma: A multicenter, randomized, double-blind, Phase 3A Clinical Trial (NIMBLE). Am J Respir Crit Care Med. 2026 Feb 11:aamag031. doi: 10.1093/ajrccm/aamag031. Online ahead of print.
• Seluk L, Davis AE, Rhoads S, Wechsler ME. Novel asthma treatments: Advancing beyond approved novel step-up therapies for asthma. Ann Allergy Asthma Immunol. 2025 Jan;134(1):9-18. doi: 10.1016/j.anai.2024.09.016. Epub 2024 Oct 10.

Study record dates

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 (Actual): May 18, 2026
• Last Update Submitted That Met QC Criteria: April 24, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Asthma; Mepolizumab; Benralizumab; GSK3511294 (Depemokimab); Interventional; Eosinophilic phenotype
• Additional Relevant MeSH Terms: Immune System Diseases; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Asthma; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality of Health Care; Quality Indicators, Health Care; Standard of Care; mepolizumab; benralizumab
• 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.: No