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En studie av GSK3511294 (Depemokimab) sammenlignet med Mepolizumab eller Benralizumab hos deltakere med alvorlig astma med en eosinofil fenotype (NIMBLE)

24. april 2026 oppdatert av: GlaxoSmithKline

En 52-ukers, randomisert, dobbeltblind, dobbel-dummy, parallell gruppe, multisenter, ikke-inferioritetsstudie som vurderer eksacerbasjonsfrekvens, ytterligere tiltak for astmakontroll og sikkerhet hos voksne og ungdommer med alvorlig astma med en eosinofil fenotype behandlet med GSK3511294 Sammenlignet med Mepolizumab eller Benralizumab

Denne studien vil vurdere om det å bytte deltakere som har hatt nytte av mepolizumab eller benralizumab til GSK3511294 (Depemokimab) ikke er dårligere enn å opprettholde dagens behandling på den årlige raten av klinisk signifikante forverringer hos deltakere med alvorlig astma med en eosinofil fenotype. Gjennom hele studien vil alle deltakerne fortsette sin ikke-biologiske Baseline Standard of Care (SoC) astmabehandling.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

1717

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • 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
  • 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
  • Forente stater
    • Alabama
      • Birmingham, Alabama, Forente stater, 35209
        • GSK Investigational Site
      • Scottsboro, Alabama, Forente stater, 35768
        • GSK Investigational Site
    • Arizona
      • Litchfield Park, Arizona, Forente stater, 85340
        • GSK Investigational Site
      • Phoenix, Arizona, Forente stater, 85054
        • GSK Investigational Site
      • Scottsdale, Arizona, Forente stater, 85251
        • GSK Investigational Site
    • California
      • Bakersfield, California, Forente stater, 93301
        • GSK Investigational Site
      • Encinitas, California, Forente stater, 92024
        • GSK Investigational Site
      • Huntington Beach, California, Forente stater, 92647
        • GSK Investigational Site
      • Los Angeles, California, Forente stater, 90048
        • GSK Investigational Site
      • Newport Beach, California, Forente stater, 92663
        • GSK Investigational Site
      • Oxnard, California, Forente stater, 93036
        • GSK Investigational Site
      • Rancho Cucamonga, California, Forente stater, 91730
        • GSK Investigational Site
      • Redondo Beach, California, Forente stater, 90277
        • GSK Investigational Site
      • Redwood City, California, Forente stater, 94063
        • GSK Investigational Site
      • Riverside, California, Forente stater, 91786
        • GSK Investigational Site
      • San Diego, California, Forente stater, 92123
        • GSK Investigational Site
      • San Diego, California, Forente stater, 92307
        • GSK Investigational Site
      • Valencia, California, Forente stater, 91324
        • GSK Investigational Site
      • Woodland, California, Forente stater, 95695
        • GSK Investigational Site
    • Colorado
      • Aurora, Colorado, Forente stater, 80238
        • GSK Investigational Site
      • Colorado Springs, Colorado, Forente stater, 80907
        • GSK Investigational Site
      • Colorado Springs, Colorado, Forente stater, 80923
        • GSK Investigational Site
      • Denver, Colorado, Forente stater, 80209
        • GSK Investigational Site
      • Wheat Ridge, Colorado, Forente stater, 80033
        • GSK Investigational Site
    • Connecticut
      • New Haven, Connecticut, Forente stater, 06511
        • GSK Investigational Site
    • Florida
      • Aventura, Florida, Forente stater, 33180
        • GSK Investigational Site
      • Clearwater, Florida, Forente stater, 33765-2103
        • GSK Investigational Site
      • Fort Lauderdale, Florida, Forente stater, 33316
        • GSK Investigational Site
      • Gainesville, Florida, Forente stater, 32610
        • GSK Investigational Site
      • Hialeah, Florida, Forente stater, 33016
        • GSK Investigational Site
      • Hialeah, Florida, Forente stater, 33014
        • GSK Investigational Site
      • Jacksonville, Florida, Forente stater, 32209
        • GSK Investigational Site
      • Kissimmee, Florida, Forente stater, 34746
        • GSK Investigational Site
      • Loxahatchee Groves, Florida, Forente stater, 33470
        • GSK Investigational Site
      • Miami, Florida, Forente stater, 33125
        • GSK Investigational Site
      • Miami, Florida, Forente stater, 33126
        • GSK Investigational Site
      • Miami, Florida, Forente stater, 33144
        • GSK Investigational Site
      • Miami, Florida, Forente stater, 33186
        • GSK Investigational Site
      • Miami, Florida, Forente stater, 33166
        • GSK Investigational Site
      • Miami, Florida, Forente stater, 33172
        • GSK Investigational Site
      • Miami Lakes, Florida, Forente stater, 33014
        • GSK Investigational Site
      • Miami Lakes, Florida, Forente stater, 33125
        • GSK Investigational Site
      • North Palm Beach, Florida, Forente stater, 33408
        • GSK Investigational Site
      • Orlando, Florida, Forente stater, 32803
        • GSK Investigational Site
      • Orlando, Florida, Forente stater, 32806
        • GSK Investigational Site
      • Orlando, Florida, Forente stater, 32819
        • GSK Investigational Site
      • Sebring, Florida, Forente stater, 33870
        • GSK Investigational Site
      • Tallahassee, Florida, Forente stater, 32308
        • GSK Investigational Site
    • Georgia
      • Calhoun, Georgia, Forente stater, 30701
        • GSK Investigational Site
    • Illinois
      • Glenview, Illinois, Forente stater, 60077
        • GSK Investigational Site
    • Indiana
      • Evansville, Indiana, Forente stater, 47715
        • GSK Investigational Site
    • Kansas
      • Overland Park, Kansas, Forente stater, 66210
        • GSK Investigational Site
    • Kentucky
      • Lexington, Kentucky, Forente stater, 40509
        • GSK Investigational Site
      • Owensboro, Kentucky, Forente stater, 42301
        • GSK Investigational Site
    • Maine
      • Bangor, Maine, Forente stater, 04401
        • GSK Investigational Site
    • Maryland
      • Baltimore, Maryland, Forente stater, 21224
        • GSK Investigational Site
      • Baltimore, Maryland, Forente stater, 21162
        • GSK Investigational Site
      • Chevy Chase, Maryland, Forente stater, 20815
        • GSK Investigational Site
    • Massachusetts
      • Boston, Massachusetts, Forente stater, 02115
        • GSK Investigational Site
      • Burlington, Massachusetts, Forente stater, 01805
        • GSK Investigational Site
      • New Bedford, Massachusetts, Forente stater, 02740
        • GSK Investigational Site
      • North Dartmouth, Massachusetts, Forente stater, 02747
        • GSK Investigational Site
    • Michigan
      • Ann Arbor, Michigan, Forente stater, 48109
        • GSK Investigational Site
      • Flint, Michigan, Forente stater, 48507
        • GSK Investigational Site
      • Warren, Michigan, Forente stater, 48088
        • GSK Investigational Site
    • Minnesota
      • Minneapolis, Minnesota, Forente stater, 55454
        • GSK Investigational Site
    • Mississippi
      • Gulfport, Mississippi, Forente stater, 36608
        • GSK Investigational Site
      • Jackson, Mississippi, Forente stater, 39216
        • GSK Investigational Site
    • Missouri
      • Chesterfield, Missouri, Forente stater, 63017
        • GSK Investigational Site
      • Saint Charles, Missouri, Forente stater, 63301
        • GSK Investigational Site
      • St Louis, Missouri, Forente stater, 63110
        • GSK Investigational Site
    • Nebraska
      • Lincoln, Nebraska, Forente stater, 68505
        • GSK Investigational Site
      • Omaha, Nebraska, Forente stater, 68198-5990
        • GSK Investigational Site
    • New Jersey
      • Brick, New Jersey, Forente stater, 08724
        • GSK Investigational Site
      • Northfield, New Jersey, Forente stater, 08225
        • GSK Investigational Site
      • Riverdale, New Jersey, Forente stater, 07457
        • GSK Investigational Site
      • Toms River, New Jersey, Forente stater, 08755
        • GSK Investigational Site
    • New York
      • Brooklyn, New York, Forente stater, 11215
        • GSK Investigational Site
      • Corning, New York, Forente stater, 14845
        • GSK Investigational Site
      • Great Neck, New York, Forente stater, 11040
        • GSK Investigational Site
      • New York, New York, Forente stater, 60301
        • GSK Investigational Site
      • The Bronx, New York, Forente stater, 10467
        • GSK Investigational Site
      • The Bronx, New York, Forente stater, 10459-2417
        • GSK Investigational Site
    • North Carolina
      • Asheville, North Carolina, Forente stater, 28803
        • GSK Investigational Site
      • Huntersville, North Carolina, Forente stater, 28078
        • GSK Investigational Site
      • Wilmington, North Carolina, Forente stater, 28401
        • GSK Investigational Site
      • Winston-Salem, North Carolina, Forente stater, 27157
        • GSK Investigational Site
      • Winston-Salem, North Carolina, Forente stater, 27103
        • GSK Investigational Site
    • Ohio
      • Cincinnati, Ohio, Forente stater, 45231
        • GSK Investigational Site
      • Cincinnati, Ohio, Forente stater, 45229
        • GSK Investigational Site
    • Oregon
      • Corvallis, Oregon, Forente stater, 97330
        • GSK Investigational Site
    • Pennsylvania
      • Altoona, Pennsylvania, Forente stater, 16601
        • GSK Investigational Site
      • Altoona, Pennsylvania, Forente stater, 15801
        • GSK Investigational Site
      • Hershey, Pennsylvania, Forente stater, 17033
        • GSK Investigational Site
      • Philadelphia, Pennsylvania, Forente stater, 19140
        • GSK Investigational Site
      • Pittsburgh, Pennsylvania, Forente stater, 15241
        • GSK Investigational Site
      • Wyomissing, Pennsylvania, Forente stater, 19610
        • GSK Investigational Site
    • Rhode Island
      • Warwick, Rhode Island, Forente stater, 02886
        • GSK Investigational Site
    • South Carolina
      • Rock Hill, South Carolina, Forente stater, 29732
        • GSK Investigational Site
      • Spartanburg, South Carolina, Forente stater, 29303
        • GSK Investigational Site
    • Tennessee
      • Hendersonville, Tennessee, Forente stater, 37075
        • GSK Investigational Site
      • Knoxville, Tennessee, Forente stater, 37909
        • GSK Investigational Site
    • Texas
      • Amarillo, Texas, Forente stater, 79106
        • GSK Investigational Site
      • Amarillo, Texas, Forente stater, 79124
        • GSK Investigational Site
      • Dallas, Texas, Forente stater, 75246
        • GSK Investigational Site
      • Dallas, Texas, Forente stater, 75235
        • GSK Investigational Site
      • Dallas, Texas, Forente stater, 75225
        • GSK Investigational Site
      • Houston, Texas, Forente stater, 77030
        • GSK Investigational Site
      • Houston, Texas, Forente stater, 77429
        • GSK Investigational Site
      • Kerrville, Texas, Forente stater, 78028
        • GSK Investigational Site
      • San Antonio, Texas, Forente stater, 78229
        • GSK Investigational Site
      • San Antonio, Texas, Forente stater, 78258
        • GSK Investigational Site
      • San Antonio, Texas, Forente stater, 78207
        • GSK Investigational Site
    • Utah
      • Murray, Utah, Forente stater, 84107
        • GSK Investigational Site
    • Virginia
      • Richmond, Virginia, Forente stater, 23298
        • GSK Investigational Site
      • Williamsburg, Virginia, Forente stater, 23188
        • GSK Investigational Site
    • Washington
      • Bellingham, Washington, Forente stater, 98225
        • GSK Investigational Site
      • Seattle, Washington, Forente stater, 98115
        • GSK Investigational Site
    • Wisconsin
      • Greenfield, Wisconsin, Forente stater, 53228
        • GSK Investigational Site
  • Frankrike
      • Amiens, Frankrike, 80000
        • GSK Investigational Site
      • Annecy, Frankrike, 74011
        • GSK Investigational Site
      • Antony, Frankrike, 92160
        • GSK Investigational Site
      • Besançon, Frankrike, 25030
        • GSK Investigational Site
      • Brest, Frankrike, 29609
        • GSK Investigational Site
      • Caen, Frankrike, 14033
        • GSK Investigational Site
      • Cannes, Frankrike, 06414
        • GSK Investigational Site
      • Cholet, Frankrike, 49300
        • GSK Investigational Site
      • Dijon, Frankrike, 21079
        • GSK Investigational Site
      • La Tronche, Frankrike, 38700
        • GSK Investigational Site
      • Le Mans, Frankrike, 72037
        • GSK Investigational Site
      • Lille, Frankrike, 59037
        • GSK Investigational Site
      • Lyon, Frankrike, 69317
        • GSK Investigational Site
      • Marseille, Frankrike, 13015
        • GSK Investigational Site
      • Marseille, Frankrike, 13003.
        • GSK Investigational Site
      • Montfermeil, Frankrike, 93370
        • GSK Investigational Site
      • Montivilliers, Frankrike, 76290
        • GSK Investigational Site
      • Montpellier, Frankrike, 34295
        • GSK Investigational Site
      • Nice, Frankrike, 06001
        • GSK Investigational Site
      • Paris, Frankrike, 75015
        • GSK Investigational Site
      • Paris, Frankrike, 75014
        • GSK Investigational Site
      • Paris, Frankrike, 75877
        • GSK Investigational Site
      • Pontoise, Frankrike, 95303
        • GSK Investigational Site
      • Rouen, Frankrike, 76031
        • GSK Investigational Site
      • Saint-Herblain, Frankrike, 44093
        • GSK Investigational Site
      • Strasbourg, Frankrike, 67091
        • GSK Investigational Site
      • Suresnes, Frankrike, 92150
        • GSK Investigational Site
      • Toulouse, Frankrike, 31059
        • GSK Investigational Site
      • Tours, Frankrike, 37044
        • GSK Investigational Site
  • Irland
      • Cork, Irland, T12 DFK4
        • GSK Investigational Site
      • Dublin, Irland, D04 T6F4
        • GSK Investigational Site
      • Dublin, Irland, 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
  • Italia
      • Bari, Italia, 70124
        • GSK Investigational Site
      • Bergamo, Italia, 24127
        • GSK Investigational Site
      • Bologna, Italia, 40138
        • GSK Investigational Site
      • Brescia, Italia, 25123
        • GSK Investigational Site
      • Catania, Italia, 95123
        • GSK Investigational Site
      • Ferrara, Italia, 44124
        • GSK Investigational Site
      • Florence, Italia, 50134
        • GSK Investigational Site
      • Genova, Italia, 16132
        • GSK Investigational Site
      • Mantua, Italia, 46100
        • GSK Investigational Site
      • Milan, Italia, 20132
        • GSK Investigational Site
      • Milan, Italia, 20122
        • GSK Investigational Site
      • Milan, Italia, 20123
        • GSK Investigational Site
      • Milan, Italia, 20162
        • GSK Investigational Site
      • Modena, Italia, 41124
        • GSK Investigational Site
      • Monserrato CA, Italia, 09042
        • GSK Investigational Site
      • Naples, Italia, 80131
        • GSK Investigational Site
      • Padova, Italia, 35128
        • GSK Investigational Site
      • Palermo, Italia, 90127
        • GSK Investigational Site
      • Pavia, Italia, 27100
        • GSK Investigational Site
      • Perugia, Italia, 06156
        • GSK Investigational Site
      • Pisa, Italia, 56100
        • GSK Investigational Site
      • Reggio Emilia, Italia, 42100
        • GSK Investigational Site
      • Roma, Italia, 168
        • GSK Investigational Site
      • Salerno, Italia, 84131
        • GSK Investigational Site
      • Sassari, Italia, 7100
        • GSK Investigational Site
      • Siena, Italia, 53100
        • GSK Investigational Site
      • Torino, Italia, 10128
        • GSK Investigational Site
      • Torrette AN, Italia, 60020
        • GSK Investigational Site
      • Treviso, Italia, 31100
        • GSK Investigational Site
      • Trieste, Italia, 34139
        • GSK Investigational Site
      • Verona, Italia, 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
  • Nederland
      • Arnhem, Nederland, 6815 AD
        • GSK Investigational Site
      • Breda, Nederland, 4818 CK
        • GSK Investigational Site
      • Deventer, Nederland, 7416 SE
        • GSK Investigational Site
      • Eindhoven, Nederland, 5623 EJ
        • GSK Investigational Site
      • Enschede, Nederland, 7513 ER
        • GSK Investigational Site
      • Harderwijk, Nederland, 3844 DG
        • GSK Investigational Site
      • Leeuwarden, Nederland, 8934 AD
        • GSK Investigational Site
      • Nijmegen, Nederland, 6532 SZ
        • GSK Investigational Site
      • Rotterdam, Nederland, 3045 PM
        • GSK Investigational Site
      • Zwolle, Nederland, 8025 AB
        • GSK Investigational Site
  • Norge
      • Bergen, Norge, 5021
        • GSK Investigational Site
      • Lrenskog, Norge, 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
  • Spania
      • Alcorcón, Spania, 28922
        • GSK Investigational Site
      • Almería, Spania, 04009
        • GSK Investigational Site
      • Badalona, Spania, 08916
        • GSK Investigational Site
      • Barcelona, Spania, 08036
        • GSK Investigational Site
      • Barcelona, Spania, 08035
        • GSK Investigational Site
      • Barcelona, Spania, 08003
        • GSK Investigational Site
      • Barcelona, Spania, 8025
        • GSK Investigational Site
      • Barcelona, Spania, 08950
        • GSK Investigational Site
      • Barcelona, Spania, 08017
        • GSK Investigational Site
      • Benalmádena, Spania, 29631
        • GSK Investigational Site
      • Bilbao, Spania, 48013
        • GSK Investigational Site
      • Granada, Spania, 18014
        • GSK Investigational Site
      • Jerez de la Frontera, Spania, 11407
        • GSK Investigational Site
      • La Laguna Santa Cruz, Spania, 38320
        • GSK Investigational Site
      • MErida Badajoz, Spania, 06800
        • GSK Investigational Site
      • Madrid, Spania, 28041
        • GSK Investigational Site
      • Madrid, Spania, 28040
        • GSK Investigational Site
      • Madrid, Spania, 28046
        • GSK Investigational Site
      • Madrid, Spania, 28031
        • GSK Investigational Site
      • Málaga, Spania, 29010
        • GSK Investigational Site
      • Pamplona, Spania, 31008
        • GSK Investigational Site
      • Pozuelo de AlarcOn Madr, Spania, 28223
        • GSK Investigational Site
      • Salamanca, Spania, 37007
        • GSK Investigational Site
      • Santander, Spania, 39008
        • GSK Investigational Site
      • Santiago de Compostela, Spania, 15706
        • GSK Investigational Site
      • Valencia, Spania, 46017
        • GSK Investigational Site
      • Valencia, Spania, 46015
        • GSK Investigational Site
      • Via-Real CastellOn, Spania, 12540
        • GSK Investigational Site
      • Vitoria-Gasteiz, Spania, 01009
        • GSK Investigational Site
      • Zaragoza, Spania, 50009
        • GSK Investigational Site
  • Storbritannia
      • Belfast, Storbritannia, BT9 7AB
        • GSK Investigational Site
      • Birmingham, Storbritannia, B9 5SS
        • GSK Investigational Site
      • Bradford, Storbritannia, BD9 6RJ
        • GSK Investigational Site
      • Bristol Avon, Storbritannia, BS10 5NB
        • GSK Investigational Site
      • Cottingham, Storbritannia, HU16 5JQ
        • GSK Investigational Site
      • Exeter, Storbritannia, EX2 5DW
        • GSK Investigational Site
      • Glasgow, Storbritannia, G31 2ER
        • GSK Investigational Site
      • Glasgow, Storbritannia, G51 4TF
        • GSK Investigational Site
      • Liverpool, Storbritannia, L7 8XP
        • GSK Investigational Site
      • London, Storbritannia, EC1A 7BE
        • GSK Investigational Site
      • Newcastle upon Tyne, Storbritannia, NE7 7DN
        • GSK Investigational Site
      • Nottingham, Storbritannia, NG5 1PB
        • GSK Investigational Site
      • Oxford, Storbritannia, OX3 9DU
        • GSK Investigational Site
      • Portsmouth, Storbritannia, PO6 3LY
        • GSK Investigational Site
      • Preston, Storbritannia, PR2 9HT
        • GSK Investigational Site
      • Wakefield, Storbritannia, WF1 4DG
        • GSK Investigational Site
      • Wishaw, Storbritannia, ML6 0JS
        • GSK Investigational Site
  • Sveits
      • Aarau, Sveits, 5001
        • GSK Investigational Site
      • Basel, Sveits, 4031
        • GSK Investigational Site
      • Liestal, Sveits, 4410
        • GSK Investigational Site
      • Sankt Gallen, Sveits, 9007
        • GSK Investigational Site
  • Sverige
      • Linköping, Sverige, SE-58758
        • GSK Investigational Site
      • Lund, Sverige, SE-221 85
        • GSK Investigational Site
      • Stockholm, Sverige, SE-141 86
        • GSK Investigational Site
      • Uppsala, Sverige, SE-751 85
        • GSK Investigational Site
      • Östersund, Sverige, SE-831 83
        • 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
  • Tyskland
      • Aschaffenburg, Tyskland, 63739
        • GSK Investigational Site
      • Bendorf, Tyskland, 56170
        • GSK Investigational Site
      • Berlin, Tyskland, 10969
        • GSK Investigational Site
      • Berlin, Tyskland, 12203
        • GSK Investigational Site
      • Berlin, Tyskland, 12159
        • GSK Investigational Site
      • Bonn, Tyskland, 53127
        • GSK Investigational Site
      • Bonn, Tyskland, 53119
        • GSK Investigational Site
      • Darmstadt, Tyskland, 64283
        • GSK Investigational Site
      • Frankfurt, Tyskland, 60596
        • GSK Investigational Site
      • Frankfurt, Tyskland, 60389
        • GSK Investigational Site
      • Fürstenwalde, Tyskland, 15517
        • GSK Investigational Site
      • Geesthacht, Tyskland, 21502
        • GSK Investigational Site
      • Halle, Tyskland, 06120
        • GSK Investigational Site
      • Halle, Tyskland, 06108
        • GSK Investigational Site
      • Hamburg, Tyskland, 20354
        • GSK Investigational Site
      • Hanover, Tyskland, 30625
        • GSK Investigational Site
      • Landsberg, Tyskland, 86899
        • GSK Investigational Site
      • Leipzig, Tyskland, 04207
        • GSK Investigational Site
      • Leipzig, Tyskland, 04275
        • GSK Investigational Site
      • Leipzig, Tyskland, 04347
        • GSK Investigational Site
      • Lübeck, Tyskland, 23552
        • GSK Investigational Site
      • Lübeck, Tyskland, 23558
        • GSK Investigational Site
      • Magdeburg, Tyskland, 39120
        • GSK Investigational Site
      • Mainz, Tyskland, 55128
        • GSK Investigational Site
      • München, Tyskland, 81241
        • GSK Investigational Site
      • Neu-Isenburg, Tyskland, 63263
        • GSK Investigational Site
      • Rheine, Tyskland, 48431
        • GSK Investigational Site
      • Schleswig, Tyskland, 24837
        • GSK Investigational Site
  • Østerrike
      • Feldbach, Østerrike, 8330
        • GSK Investigational Site
      • Vienna, Østerrike, 1130
        • GSK Investigational Site

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

12 år og eldre (Barn, Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Beskrivelse

Viktige inklusjonskriterier for studien:

  • Voksne og ungdomsdeltakere over eller lik (>=)12 år, på tidspunktet for undertegning av informert samtykke/samtykke.
  • Deltakere som har en dokumentert legediagnose for astma i >=2 år som oppfyller retningslinjer fra National Heart, Lung, and Blood Institute (NHLBI) eller Global Initiative for Asthma (GINA).

  • Deltakere som mottar enten mepolizumab 100 milligram (mg) eller benralizumab 30 mg i >=12 måneder før screening og har en dokumentert fordel for behandlingen vurdert ved enten:

    (i) >=50 % reduksjon i eksacerbasjonsfrekvens siden behandlingsstart, eller (ii) >=50 % reduksjon i vedlikeholds-OCS-bruk siden behandlingsstart, eller (iii) Ingen eksacerbasjoner de siste 6 månedene mens du mottok anti-IL-5 /5R-terapi og et astmakontrollspørreskjema (ACQ)-5-score på mindre enn eller lik (

  • Et godt dokumentert krav om regelmessig behandling med middels til høy dose ICS i 12 måneder før besøk 1 med eller uten vedlikeholds-OCS. Vedlikeholds-ICS-dosen må være >=440 mikrogram (mcg) flutikasonpropionat (FP) hydrofluoralkan (HFA) produkt daglig, eller klinisk sammenlignbar. Deltakere som behandles med middels dose ICS må også behandles med en LABA for å kvalifisere for inkludering.
  • Gjeldende behandling med minst én ekstra kontrollmedisin, foruten ICS [for eksempel (f.eks.), LABA, LAMA, leukotrienreseptorantagonist (LTRA) eller teofyllin].

Viktige eksklusjonskriterier for studiet:

  • Deltakere med tilstedeværelse av en kjent forhåndseksisterende, klinisk viktig lungetilstand annet enn astma. Dette inkluderer (men er ikke begrenset til) nåværende infeksjon, bronkiektasi, lungefibrose, bronkopulmonal aspergillose eller diagnoser av emfysem eller kronisk bronkitt (kronisk obstruktiv lungesykdom annet enn astma) eller en historie med lungekreft.
  • Deltakere med andre tilstander som kan føre til forhøyede eosinofiler som hypereosinofile syndromer inkludert (men ikke begrenset til) eosinofil granulomatose med polyangiitt (EGPA, tidligere kjent som Churg-Strauss syndrom) eller eosinofil øsofagitt.
  • En nåværende malignitet eller tidligere historie med kreft i remisjon i mindre enn 12 måneder før screening (deltakere som hadde lokalisert karsinom i huden som ble resekert for helbredelse vil ikke bli ekskludert).
  • Skrumplever eller nåværende ustabil lever- eller gallesykdom per etterforskers vurdering definert av tilstedeværelsen av ascites, encefalopati, koagulopati, hypoalbuminemi, esophageal eller gastriske varicer, vedvarende gulsott.
  • Deltakere med gjeldende diagnose vaskulitt. Deltakere med høy klinisk mistanke om vaskulitt ved screening vil bli evaluert og aktuell vaskulitt ekskludert før påmelding.
  • Deltakere som har mottatt Omalizumab (Xolair), dupilumab (Dupixent) eller reslizumab (Cinqair/Cinqaero) innen 130 dager før besøk 1.
  • Deltakere som har mottatt et monoklonalt antistoff (mAb) innen 5 halveringstider etter besøk 1.
  • Korrigert QT-intervall med Fridericias formel (QTcF) >=450 millisekunder (ms) eller QTcF >=480 msek for deltakere med Bundle Branch Block ved screeningbesøk 1.
  • Nåværende røykere eller tidligere røykere med en røykehistorie på >=10 pakkeår (antall pakkeår lik [antall sigaretter per dag/20] ganger antall år røykt). En tidligere røyker er definert som en deltaker som sluttet å røyke minst 6 måneder før besøk 1.
  • Deltakere med allergi/intoleranse mot en mAb eller biologisk legemiddel.

Viktige eksklusjonskriterier for randomisering:

  • Bevis på en klinisk signifikant abnormitet i 12-avlednings elektrokardiogram (EKG) overavlesning utført ved screeningbesøk 1, basert på evalueringen av etterforskeren, eller QTcF >=450 msec eller QTcF >=480 msec for deltakere med Bundle Branch Block , ved randomisering besøk 2.
  • Deltakere med en klinisk signifikant astmaforverring de 7 dagene før randomiseringen bør få randomiseringsbesøket forsinket inntil etterforskeren vurderer deltakerens astma som stabil. Hvis den 8-ukers screeningsperioden har gått, bør deltakeren betraktes som en innkjøringssvikt.
  • Eventuelle endringer i dosen eller regimet av Baseline ICS og/eller tilleggskontrollmedisin (bortsett fra behandling av en forverring) i løpet av innkjøringsperioden.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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).
Biologisk: Placebo
Placebo vil være en steril flytende formulering.
Legemiddel: Standard for omsorg (SoC)
Ikke-biologisk SoC vil inkludere inhalert kortikosteroid (ICS) pluss minst én annen kontroller, langtidsvirkende beta-2-agonist (LABA), langtidsvirkende muskarin antagonist (LAMA), med eller uten vedlikeholds orale kortikosteroider (OCS).
Enhet: Ferdigfylte sprøyter (PFS)
PFS vil inkludere glassfat med forhåndsutsatt nål og stempel.
Biologisk: GSK3511294 (Depemokimab)
GSK3511294 (Depemokimab) 100 mg SC along with the placebo and SOC will be administered.
Aktiv komparator: 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.
Biologisk: Placebo
Placebo vil være en steril flytende formulering.
Legemiddel: Standard for omsorg (SoC)
Ikke-biologisk SoC vil inkludere inhalert kortikosteroid (ICS) pluss minst én annen kontroller, langtidsvirkende beta-2-agonist (LABA), langtidsvirkende muskarin antagonist (LAMA), med eller uten vedlikeholds orale kortikosteroider (OCS).
Enhet: Ferdigfylte sprøyter (PFS)
PFS vil inkludere glassfat med forhåndsutsatt nål og stempel.
Biologisk: Mepolizumab
Mepolizumab 100 mg SC will be administered in a single-use PFS.
Biologisk: Benralizumab
Benralizumab 30 mg will be administered in a single-use PFS.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Annualized Rate of Clinically Significant Exacerbations Over 52 Weeks
Tidsramme: Up to Week 52
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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Weighted Mean (WM) Change From Baseline in St. George's Respiratory Questionnaire (SGRQ) Total Score
Tidsramme: From Baseline (Day 1) up to Week 52
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
Tidsramme: From Baseline (Day 1) up to Week 52
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)
Tidsramme: From Baseline (Day 1) up to Week 52
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

GlaxoSmithKline

Samarbeidspartnere

IQVIA Pty Ltd

Etterforskere

  • Studieleder: GSK Clinical Trials, GlaxoSmithKline

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

26. januar 2021

Primær fullføring (Faktiske)

14. september 2025

Studiet fullført (Faktiske)

14. september 2025

Datoer for studieregistrering

Først innsendt

18. januar 2021

Først innsendt som oppfylte QC-kriteriene

18. januar 2021

Først lagt ut (Faktiske)

22. januar 2021

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

18. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

24. april 2026

Sist bekreftet

1. april 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 206785

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

IPD for denne studien vil bli gjort tilgjengelig via nettstedet for forespørsel om kliniske studier.

IPD-delingstidsramme

IPD vil bli gjort tilgjengelig innen 6 måneder etter publisering av resultatene av de primære endepunktene, sentrale sekundære endepunkter og sikkerhetsdata for studien.

Tilgangskriterier for IPD-deling

Tilgang gis etter at et forskningsforslag er sendt inn og har mottatt godkjenning fra det uavhengige granskingspanelet og etter at en datadelingsavtale er på plass. Tilgang gis for en innledende periode på 12 måneder, men en forlengelse kan gis, når det er berettiget, i inntil ytterligere 12 måneder.

IPD-deling Støtteinformasjonstype

  • STUDY_PROTOCOL
  • SEVJE
  • ICF
  • CSR

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Ja

produkt produsert i og eksportert fra USA

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere