Benralizumab Efficacy in Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD) With Exacerbation History (GALATHEA)

Randomised, Double-blind, 56 Week Placebo-controlled, Parallel Group, Multicentre, Phase 3 Study to Evaluate the Efficacy and Safety of 2 Doses of Benralizumab in Patients With Moderate to Very Severe COPD With a History of Exacerbations

The purpose of the study is to determine if benralizumab reduces COPD exacerbation rate in symptomatic patients with moderate to very severe COPD who are receiving standard of care therapies

Study Overview

• Status: Completed
• Conditions: Moderate to Very Severe Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Drug: Benralizumab Arm A; Drug: Benralizumab Arm B; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 1656
• Phase: Phase 3

Contacts and Locations

Study Locations

• Austria
  • Feldkirch, Austria, 6800
    • Research Site
  • Graz, Austria, 8036
    • Research Site
  • Innsbruck, Austria, 6020
    • Research Site
  • Linz, Austria, 4020
    • Research Site
  • Salzburg, Austria, 5020
    • Research Site
  • Wels, Austria, 4600
    • Research Site
  • Wien, Austria, 1140
    • Research Site
• Canada
  • Quebec, Canada, G1G 3Y8
    • Research Site
  • Quebec, Canada, G1V 4G5
    • Research Site
  • Alberta
    • Calgary, Alberta, Canada, T2N 4Z6
      • Research Site
    • Calgary, Alberta, Canada, T2Y 2Z7
      • Research Site
    • Sherwood Park, Alberta, Canada, T8L 0N2
      • Research Site
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 1M9
      • Research Site
    • Vancouver, British Columbia, Canada, V6Z 1Y6
      • Research Site
  • Ontario
    • Ajax, Ontario, Canada, L1Z 0M1
      • Research Site
    • Burlington, Ontario, Canada, L7N 3V2
      • Research Site
    • Grimsby, Ontario, Canada, L3M 1P3
      • Research Site
    • Hamilton, Ontario, Canada, L8N 3Z5
      • Research Site
  • Quebec
    • Montreal, Quebec, Canada, H4J 1C5
      • Research Site
    • Pointe-Claire, Quebec, Canada, H9R 3J1
      • Research Site
    • Quebec City, Quebec, Canada, G1V 4W2
      • Research Site
    • St Charles Borromee, Quebec, Canada, J6E 2B4
      • Research Site
    • Trois Rivieres, Quebec, Canada, G8T 7A1
      • Research Site
  • Saskatchewan
    • Saskatoon, Saskatchewan, Canada, S7N 0W8
      • Research Site
• Czechia
  • Jindrichuv Hradec, Czechia, 377 01
    • Research Site
  • Karlovy Vary, Czechia, 360 17
    • Research Site
  • Kralupy nad Vltavou, Czechia, 278 01
    • Research Site
  • Mlada Boleslav, Czechia, 293 50
    • Research Site
  • Olomouc, Czechia, 775 21
    • Research Site
  • Praha 8, Czechia, 182 00
    • Research Site
  • Rokycany, Czechia, 337 22
    • Research Site
  • Strakonice, Czechia, 386 01
    • Research Site
  • Teplice, Czechia, 415 01
    • Research Site
• Germany
  • Bamberg, Germany, 96049
    • Research Site
  • Berlin, Germany, 10787
    • Research Site
  • Berlin, Germany, 13187
    • Research Site
  • Bonn, Germany, 53123
    • Research Site
  • Frankfurt, Germany, 60596
    • Research Site
  • Frankfurt am Main, Germany, 60596
    • Research Site
  • Frankfurt/Main, Germany, 60389
    • Research Site
  • Geesthacht, Germany, 21502
    • Research Site
  • Hamburg, Germany, 20354
    • Research Site
  • Leipzig, Germany, 04357
    • Research Site
  • Marburg, Germany, 35043
    • Research Site
  • Neu-Isenburg, Germany, 63263
    • Research Site
  • Rodgau-Dudenhofen, Germany, 63110
    • Research Site
  • Teuchern, Germany, 06682
    • Research Site
  • Witten, Germany, 58452
    • Research Site
• Hungary
  • Balassagyarmat, Hungary, 2660
    • Research Site
  • Budapest, Hungary, 1135
    • Research Site
  • Budapest, Hungary, 1204
    • Research Site
  • Edelény, Hungary, 3780
    • Research Site
  • Farkasgyepü, Hungary, 8582
    • Research Site
  • Gödöllő, Hungary, 2100
    • Research Site
  • Hajdúnánás, Hungary, 4080
    • Research Site
  • Hatvan, Hungary, 3000
    • Research Site
  • Miskolc, Hungary, 3529
    • Research Site
  • Mátraháza, Hungary, 3233
    • Research Site
  • Pécs, Hungary, 7626
    • Research Site
  • Pécs, Hungary, 7635
    • Research Site
  • Szeged, Hungary, H-6722
    • Research Site
  • Százhalombatta, Hungary, 2440
    • Research Site
  • Székesfehérvár, Hungary, 8000
    • Research Site
• Italy
  • Bolzano, Italy, 39100
    • Research Site
  • Catania, Italy, 95123
    • Research Site
  • Ferrara, Italy, 44100
    • Research Site
  • Genova, Italy, 16132
    • Research Site
  • Orbassano, Italy, 10043
    • Research Site
  • Palermo, Italy, 90146
    • Research Site
  • Parma, Italy, 43100
    • Research Site
  • Pavia, Italy, 27100
    • Research Site
  • Pisa, Italy, 56124
    • Research Site
  • Tradate, Italy, 21049
    • Research Site
• Japan
  • Chuo-ku, Japan, 103-0027
    • Research Site
  • Fukuoka-shi, Japan, 811-1394
    • Research Site
  • Fukuoka-shi, Japan, 819-8555
    • Research Site
  • Fukuyama-shi, Japan, 720-0001
    • Research Site
  • Higashiibaraki-gun, Japan, 311-3193
    • Research Site
  • Himeji-shi, Japan, 672-8064
    • Research Site
  • Himeji-shi, Japan, 670-0849
    • Research Site
  • Hirosaki-shi, Japan, 036-8545
    • Research Site
  • Iwata-shi, Japan, 438-8550
    • Research Site
  • Izumo-shi, Japan, 693-8501
    • Research Site
  • Joyo-shi, Japan, 610-0113
    • Research Site
  • Kagoshima-shi, Japan, 890-0064
    • Research Site
  • Kasuga-shi, Japan, 816-0813
    • Research Site
  • Kasugai-shi, Japan, 486-8510
    • Research Site
  • Kawaguchi-shi, Japan, 333-0833
    • Research Site
  • Kawasaki-shi, Japan, 211-0041
    • Research Site
  • Kiryu-shi, Japan, 376-0024
    • Research Site
  • Kishiwada-shi, Japan, 596-8501
    • Research Site
  • Kitakami-shi, Japan, 024-8506
    • Research Site
  • Kobe-shi, Japan, 650-0047
    • Research Site
  • Kochi-shi, Japan, 780-8077
    • Research Site
  • Kodaira-shi, Japan, 187-0024
    • Research Site
  • Kokubunji-shi, Japan, 185-0014
    • Research Site
  • Koshi-shi, Japan, 861-1196
    • Research Site
  • Kuki-shi, Japan, 349-1105
    • Research Site
  • Kumamoto-shi, Japan, 862-0921
    • Research Site
  • Kurashiki-shi, Japan, 711-0921
    • Research Site
  • Kurume-shi, Japan, 830-0011
    • Research Site
  • Kyoto-shi, Japan, 615-8256
    • Research Site
  • Matsue-shi, Japan, 690-8556
    • Research Site
  • Matsue-shi, Japan, 690-8506
    • Research Site
  • Matsumoto-shi, Japan, 390-0872
    • Research Site
  • Matsusaka-shi, Japan, 515-8544
    • Research Site
  • Meguro-ku, Japan, 153-8515
    • Research Site
  • Mizunami-shi, Japan, 509-6134
    • Research Site
  • Morioka-shi, Japan, 020-0055
    • Research Site
  • Nagaoka-shi, Japan, 940-8621
    • Research Site
  • Nagoya-shi, Japan, 455-8530
    • Research Site
  • Nagoya-shi, Japan, 454-8509
    • Research Site
  • Niigata-shi, Japan, 950-2085
    • Research Site
  • Obihiro-shi, Japan, 080-0805
    • Research Site
  • Ohota-ku, Japan, 145-0063
    • Research Site
  • Ota-shi, Japan, 373-8585
    • Research Site
  • Saiki-shi, Japan, 876-0813
    • Research Site
  • Sakai-shi, Japan, 591-8555
    • Research Site
  • Sakaide-shi, Japan, 762-8550
    • Research Site
  • Sapporo-shi, Japan, 001-0901
    • Research Site
  • Sapporo-shi, Japan, 064-0804
    • Research Site
  • Sapporo-shi, Japan, 063-0005
    • Research Site
  • Sapporo-shi, Japan, 060-0033
    • Research Site
  • Sendai-shi, Japan, 984-8560
    • Research Site
  • Seto-shi, Japan, 489-8642
    • Research Site
  • Shinagawa-ku, Japan, 142-8666
    • Research Site
  • Shinjuku-ku, Japan, 162-8655
    • Research Site
  • Takamatsu-shi, Japan, 761-8073
    • Research Site
  • Takatsuki-shi, Japan, 569-1096
    • Research Site
  • Toon-shi, Japan, 791-0281
    • Research Site
  • Toshima-ku, Japan, 171-0014
    • Research Site
  • Ube-shi, Japan, 755-0241
    • Research Site
  • Ueda-shi, Japan, 386-8610
    • Research Site
  • Uji-shi, Japan, 611-0041
    • Research Site
  • Urasoe-shi, Japan, 901-2132
    • Research Site
  • Uruma-shi, Japan, 904-2293
    • Research Site
  • Yachiyo-shi, Japan, 276-8524
    • Research Site
  • Yanagawa-shi, Japan, 832-0059
    • Research Site
  • Yao-shi, Japan, 581-0011
    • Research Site
  • Yokohama-shi, Japan, 232-0024
    • Research Site
  • Yokohama-shi, Japan, 236-0004
    • Research Site
  • Yokohama-shi, Japan, 234-0054
    • Research Site
  • Yokohama-shi, Japan, 236-0051
    • Research Site
• Korea, Republic of
  • Bucheon-si, Korea, Republic of, 14584
    • Research Site
  • Daegu, Korea, Republic of, 42415
    • Research Site
  • Seoul, Korea, Republic of, 06591
    • Research Site
  • Seoul, Korea, Republic of, 03312
    • Research Site
  • Seoul, Korea, Republic of, 04401
    • Research Site
  • Seoul, Korea, Republic of, 05030
    • Research Site
  • Wonju-si, Korea, Republic of, 26426
    • Research Site
• Netherlands
  • Breda, Netherlands, 4818 CK
    • Research Site
  • Eindhoven, Netherlands, 5623 EJ
    • Research Site
  • Heerlen, Netherlands, 6419 PC
    • Research Site
  • Horn, Netherlands, 6085 NM
    • Research Site
  • Nijmegen, Netherlands, 6525 GA
    • Research Site
  • Zwolle, Netherlands, 8025 AB
    • Research Site
• Poland
  • Bydgoszcz, Poland, 85-681
    • Research Site
  • Dobre Miasto, Poland, 11-040
    • Research Site
  • Gdańsk, Poland
    • Research Site
  • Gdańsk, Poland, 80-405
    • Research Site
  • Katowice, Poland, 40-081
    • Research Site
  • Kościan, Poland, 64-000
    • Research Site
  • Kraków, Poland, 31-011
    • Research Site
  • Kraków, Poland, 31-209
    • Research Site
  • Lublin, Poland, 20-089
    • Research Site
  • Lublin, Poland, 20-064
    • Research Site
  • Lublin, Poland, 20-468
    • Research Site
  • Mrozy, Poland, 05-320
    • Research Site
  • Mrągowo, Poland, 11-700
    • Research Site
  • Olsztyn, Poland, 10-357
    • Research Site
  • Proszowice, Poland, 32-100
    • Research Site
  • Radom, Poland, 26-617
    • Research Site
  • Ruda Slaska, Poland, 41-709
    • Research Site
  • Rzeszów, Poland, 35-241
    • Research Site
  • Tarnów, Poland, 33-100
    • Research Site
  • Warszawa, Poland, 02-507
    • Research Site
  • Wroclaw, Poland, 53-201
    • Research Site
  • Wrocław, Poland, 50-220
    • Research Site
  • Zakopane, Poland
    • Research Site
  • Łódź, Poland, 90-153
    • Research Site
• Romania
  • Bragadiru, Romania, 077025
    • Research Site
  • Brasov, Romania, 500283
    • Research Site
  • Bucharest, Romania, 030303
    • Research Site
  • Bucharest, Romania, 71593
    • Research Site
  • Constanta, Romania, 900002
    • Research Site
  • Deva, Romania, 330061
    • Research Site
  • Iasi, Romania, 700115
    • Research Site
  • Timisoara, Romania, 300310
    • Research Site
• Russian Federation
  • Chelyabinsk, Russian Federation, 454021
    • Research Site
  • Ekaterinburg, Russian Federation, 620039
    • Research Site
  • Ekaterinburg, Russian Federation, 620109
    • Research Site
  • Ekaterinburg, Russian Federation, 620137
    • Research Site
  • Ekaterinburg, Russian Federation, 620219
    • Research Site
  • Ivanovo, Russian Federation, 153005
    • Research Site
  • Izhevsk, Russian Federation, 426035
    • Research Site
  • Kazan, Russian Federation, 420012
    • Research Site
  • Kemerovo, Russian Federation, 650066
    • Research Site
  • Kemerovo, Russian Federation, 650000
    • Research Site
  • Kemerovo, Russian Federation, 650002
    • Research Site
  • Moscow, Russian Federation, 127473
    • Research Site
  • Moscow, Russian Federation, 121309
    • Research Site
  • Moscow, Russian Federation, 127018
    • Research Site
  • Moscow, Russian Federation, 109240
    • Research Site
  • Moscow, Russian Federation, 117593
    • Research Site
  • Nizhny Novgorod, Russian Federation, 603126
    • Research Site
  • Novosibirsk, Russian Federation, 630008
    • Research Site
  • Novosibirsk, Russian Federation, 630051
    • Research Site
  • Novosibirsk, Russian Federation, 630084
    • Research Site
  • Penza, Russian Federation, 440067
    • Research Site
  • Perm, Russian Federation, 614068
    • Research Site
  • Pskov, Russian Federation, 180007
    • Research Site
  • Pyatigorsk, Russian Federation, 357500
    • Research Site
  • Ryazan, Russian Federation, 390026
    • Research Site
  • Saint Petersburg, Russian Federation, 194354
    • Research Site
  • Saint Petersburg, Russian Federation, 197342
    • Research Site
  • Saint Petersburg, Russian Federation, 193312
    • Research Site
  • Saint-Petersburg, Russian Federation, 196084
    • Research Site
  • Saint-Petersburg, Russian Federation, 194354
    • Research Site
  • Saratov, Russian Federation, 410012
    • Research Site
  • Smolensk, Russian Federation, 214019
    • Research Site
  • St. Petersburg, Russian Federation, 196247
    • Research Site
  • St. Petersburg, Russian Federation, 197089
    • Research Site
  • St.Petersburg, Russian Federation, 194354
    • Research Site
  • Tomsk, Russian Federation, 634050
    • Research Site
  • Tomsk, Russian Federation, 634063
    • Research Site
  • Ufa, Russian Federation, 450071
    • Research Site
  • Ulyanovsk, Russian Federation, 432009
    • Research Site
  • Vladikavkaz, Russian Federation, 362007
    • Research Site
  • Vladimir, Russian Federation, 600023
    • Research Site
  • Volgograd, Russian Federation, 400001
    • Research Site
  • Volgograd, Russian Federation, 400131
    • Research Site
• South Africa
  • Amanzimtoti, South Africa, 4126
    • Research Site
  • Bloemfontein, South Africa, 9301
    • Research Site
  • Cape Town, South Africa, 7764
    • Research Site
  • Durban, South Africa, 4001
    • Research Site
  • Gauteng, South Africa, 2193
    • Research Site
  • Middelburg, South Africa, 1055
    • Research Site
• Spain
  • Alicante, Spain, 03004
    • Research Site
  • Badalona(Barcelona), Spain, 08916
    • Research Site
  • Barcelona, Spain, 08036
    • Research Site
  • Barcelona, Spain, 08003
    • Research Site
  • Barcelona, Spain, 08025
    • Research Site
  • Madrid, Spain, 28040
    • Research Site
  • Málaga, Spain, 29010
    • Research Site
  • Palma de Mallorca, Spain, 07010
    • Research Site
  • Sabadell (Barcelona), Spain, 08208
    • Research Site
  • Santander, Spain, 39008
    • Research Site
  • Valencia, Spain, 46015
    • Research Site
• Switzerland
  • Basel, Switzerland, 4031
    • Research Site
  • Biel, Switzerland, 2502
    • Research Site
  • Gossau, Switzerland, CH-9202
    • Research Site
  • Liestal, Switzerland, CH-4410
    • Research Site
  • St. Gallen, Switzerland, 9007
    • Research Site
• United Kingdom
  • Aberdeen, United Kingdom, AB25 2ZG
    • Research Site
  • Birmingham, United Kingdom, B9 5SS
    • Research Site
  • Bradford, United Kingdom, BD9 6RJ
    • Research Site
  • Cambridge, United Kingdom, CB2 0QQ
    • Research Site
  • Chertsey, United Kingdom, KT16 0PZ
    • Research Site
  • Edinburgh, United Kingdom, EH16 4TJ
    • Research Site
  • Glasgow, United Kingdom, G12 0YN
    • Research Site
  • Le3 9qp, United Kingdom
    • Research Site
  • London, United Kingdom, SE5 9PJ
    • Research Site
  • Manchester, United Kingdom, M23 9QZ
    • Research Site
  • Manchester, United Kingdom, M6 8HD
    • Research Site
  • Newcastle-Under-Lyme, United Kingdom, ST4 6QG
    • Research Site
  • Newcastle-Upon-Tyne, United Kingdom, NE7 7DN
    • Research Site
  • Oxford, United Kingdom, OX3 7LE
    • Research Site
  • Plymouth, United Kingdom, PL6 8DH
    • Research Site
  • Southampton, United Kingdom, SO166YD
    • Research Site
  • Wishaw, United Kingdom, ML2 0DP
    • Research Site
  • Wolverhampton, United Kingdom, WV10 0QP
    • Research Site
• United States
  • Alabama
    • Andalusia, Alabama, United States, 36420
      • Research Site
    • Birmingham, Alabama, United States, 35294
      • Research Site
    • Birmingham, Alabama, United States, 35243
      • Research Site
    • Dothan, Alabama, United States, 36305
      • Research Site
    • Jasper, Alabama, United States, 35501
      • Research Site
  • Arkansas
    • Little Rock, Arkansas, United States, 72209
      • Research Site
  • California
    • Beverly Hills, California, United States, 90212
      • Research Site
    • Gold River, California, United States, 95670
      • Research Site
    • Huntington Beach, California, United States, 92647
      • Research Site
    • Huntington Park, California, United States, 90255-6046
      • Research Site
    • Lakewood, California, United States, 90805
      • Research Site
    • Lomita, California, United States, 90717
      • Research Site
    • Newport Beach, California, United States, 92663
      • Research Site
    • Palm Desert, California, United States, 92260
      • Research Site
    • Palo Alto, California, United States, 94304
      • Research Site
    • Riverside, California, United States, 92506
      • Research Site
    • Sacramento, California, United States, 95817
      • Research Site
    • San Diego, California, United States, 92103
      • Research Site
    • Santa Ana, California, United States, 92704
      • Research Site
    • Thousand Oaks, California, United States, 91360
      • Research Site
    • Torrance, California, United States, 90502
      • Research Site
  • Connecticut
    • New Haven, Connecticut, United States, 06520-8057
      • Research Site
    • Waterbury, Connecticut, United States, 06708
      • Research Site
  • Florida
    • Boynton Beach, Florida, United States, 33435
      • Research Site
    • Brandon, Florida, United States, 33511
      • Research Site
    • Clearwater, Florida, United States, 33765
      • Research Site
    • Clearwater, Florida, United States, 33756
      • Research Site
    • Fort Lauderdale, Florida, United States, 33316
      • Research Site
    • Gainesville, Florida, United States, 32608
      • Research Site
    • Hialeah, Florida, United States, 33012
      • Research Site
    • Kissimmee, Florida, United States, 34741
      • Research Site
    • Loxahatchee Groves, Florida, United States, 33470
      • Research Site
    • Miami, Florida, United States, 33126
      • Research Site
    • Miami, Florida, United States, 33144
      • Research Site
    • Miami, Florida, United States, 33155
      • Research Site
    • Miami, Florida, United States, 33015
      • Research Site
    • Miami Springs, Florida, United States, 33166
      • Research Site
    • Orlando, Florida, United States, 32803
      • Research Site
    • Orlando, Florida, United States, 32825
      • Research Site
    • Orlando, Florida, United States, 32819
      • Research Site
    • Panama City, Florida, United States, 32405
      • Research Site
    • Port Orange, Florida, United States, 32129
      • Research Site
    • Saint Petersburg, Florida, United States, 33713
      • Research Site
    • Saint Petersburg, Florida, United States, 33707
      • Research Site
    • Sebring, Florida, United States, 33870
      • Research Site
    • Vero Beach, Florida, United States, 32960
      • Research Site
    • Winter Park, Florida, United States, 32789-4681
      • Research Site
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • Research Site
    • Calhoun, Georgia, United States, 30701
      • Research Site
    • Decatur, Georgia, United States, 30033
      • Research Site
    • Duluth, Georgia, United States, 30096
      • Research Site
    • Marietta, Georgia, United States, 30060
      • Research Site
  • Idaho
    • Eagle, Idaho, United States, 83616
      • Research Site
  • Illinois
    • Aurora, Illinois, United States, 60506
      • Research Site
    • Chicago, Illinois, United States, 60602
      • Research Site
    • Evanston, Illinois, United States, 60201
      • Research Site
  • Indiana
    • Michigan City, Indiana, United States, 46360
      • Research Site
    • Valparaiso, Indiana, United States, 46383
      • Research Site
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • Research Site
  • Kentucky
    • Fort Mitchell, Kentucky, United States, 41017
      • Research Site
    • Hazard, Kentucky, United States, 41701
      • Research Site
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • Research Site
    • Baltimore, Maryland, United States, 21224
      • Research Site
    • Columbia, Maryland, United States, 21044
      • Research Site
  • Massachusetts
    • North Dartmouth, Massachusetts, United States, 02747
      • Research Site
  • Michigan
    • Farmington Hills, Michigan, United States, 48336
      • Research Site
    • Rochester, Michigan, United States, 48307
      • Research Site
  • Minnesota
    • Minneapolis, Minnesota, United States, 55407
      • Research Site
  • Missouri
    • Saint Charles, Missouri, United States, 63301
      • Research Site
    • Saint Louis, Missouri, United States, 63143
      • Research Site
  • Nevada
    • Las Vegas, Nevada, United States, 89123
      • Research Site
  • New Jersey
    • Summit, New Jersey, United States, 07901
      • Research Site
  • New Mexico
    • Albuquerque, New Mexico, United States, 87108
      • Research Site
  • New York
    • Bronxville, New York, United States, 10708
      • Research Site
    • Brooklyn, New York, United States, 11229
      • Research Site
    • Buffalo, New York, United States, 14215
      • Research Site
    • Fayetteville, New York, United States, 13066
      • Research Site
    • New York, New York, United States, 10022
      • Research Site
    • New York, New York, United States, 10036
      • Research Site
  • North Carolina
    • Asheville, North Carolina, United States, 28801
      • Research Site
    • Charlotte, North Carolina, United States, 28207
      • Research Site
    • Durham, North Carolina, United States, 27705
      • Research Site
    • Elizabeth City, North Carolina, United States, 27909
      • Research Site
    • Gastonia, North Carolina, United States, 28054
      • Research Site
    • Greensboro, North Carolina, United States, 27401
      • Research Site
    • Mount Airy, North Carolina, United States, 27030
      • Research Site
    • New Bern, North Carolina, United States, 28562
      • Research Site
    • Wilmington, North Carolina, United States, 28401
      • Research Site
    • Winston-Salem, North Carolina, United States, 27103
      • Research Site
    • Winston-Salem, North Carolina, United States, 27104
      • Research Site
  • Ohio
    • Canton, Ohio, United States, 44718
      • Research Site
    • Cincinnati, Ohio, United States, 45231
      • Research Site
    • Cincinnati, Ohio, United States, 45242
      • Research Site
    • Cincinnati, Ohio, United States, 45220
      • Research Site
    • Dayton, Ohio, United States, 45459
      • Research Site
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73112
      • Research Site
    • Oklahoma City, Oklahoma, United States, 73116
      • Research Site
    • Oklahoma City, Oklahoma, United States, 73103
      • Research Site
  • Oregon
    • Bend, Oregon, United States, 97701
      • Research Site
    • Medford, Oregon, United States, 97504
      • Research Site
    • Portland, Oregon, United States, 97239
      • Research Site
  • Pennsylvania
    • Altoona, Pennsylvania, United States, 16602
      • Research Site
    • Erie, Pennsylvania, United States, 16508
      • Research Site
    • Jefferson Hills, Pennsylvania, United States, 15025
      • Research Site
    • Philadelphia, Pennsylvania, United States, 19140
      • Research Site
    • Pittsburgh, Pennsylvania, United States, 15213
      • Research Site
    • Wyomissing, Pennsylvania, United States, 19610
      • Research Site
  • South Carolina
    • Charleston, South Carolina, United States, 29406
      • Research Site
    • Columbia, South Carolina, United States, 29201
      • Research Site
    • Gaffney, South Carolina, United States, 29340
      • Research Site
    • Greenville, South Carolina, United States, 29615
      • Research Site
    • Indian Land, South Carolina, United States, 29707
      • Research Site
    • Mount Pleasant, South Carolina, United States, 29464
      • Research Site
    • Rock Hill, South Carolina, United States, 29732
      • Research Site
    • Spartanburg, South Carolina, United States, 29303
      • Research Site
  • South Dakota
    • Rapid City, South Dakota, United States, 57702
      • Research Site
  • Tennessee
    • Chattanooga, Tennessee, United States, 37404
      • Research Site
    • Franklin, Tennessee, United States, 37067
      • Research Site
    • Hendersonville, Tennessee, United States, 37075
      • Research Site
  • Texas
    • Arlington, Texas, United States, 76012
      • Research Site
    • Austin, Texas, United States, 78704
      • Research Site
    • Boerne, Texas, United States, 78006
      • Research Site
    • Frisco, Texas, United States, 75034
      • Research Site
    • Galveston, Texas, United States, 77555
      • Research Site
    • Houston, Texas, United States, 77084
      • Research Site
    • Houston, Texas, United States, 77081
      • Research Site
    • Houston, Texas, United States, 77077
      • Research Site
    • McAllen, Texas, United States, 78504
      • Research Site
    • San Antonio, Texas, United States, 78229
      • Research Site
    • San Antonio, Texas, United States, 78215
      • Research Site
    • Tyler, Texas, United States, 75708
      • Research Site
  • Utah
    • Midvale, Utah, United States, 84047
      • Research Site
    • Provo, Utah, United States, 84604
      • Research Site
  • Virginia
    • Richmond, Virginia, United States, 23225
      • Research Site
    • Richmond, Virginia, United States, 23220
      • Research Site
    • Richmond, Virginia, United States, 23219
      • Research Site
    • Richmond, Virginia, United States, 23229
      • Research Site
  • Washington
    • Richland, Washington, United States, 99352
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:1.Informed consent. 2.Subjects 40-85 y.o. 3.Moderate to very severe COPD with Post Bronchodilator (BD) FEV1>20% and ≤65%. 4.≥2 moderate or ≥1 severe COPD exacerbation(s) required treatment or hospitalization within 2-52 weeks prior to Visit1. 5. Modified Medical Research Council (mMRC) score ≥1 at Visit 1. 6.Treatment with double or triple therapy throughout the year prior to Visit 1, constant 2 weeks prior to Visit 1. 7.Tobacco history of ≥10 pack-years. 8.Women of childbearing potential must use a highly effective form of birth control from Visit 1 until 16 weeks after their last dose, and negative serum pregnancy test result at Visit 1. 9.Male subjects who are sexually active must be surgically sterile one year prior to Visit 1 or use an adequate method of contraception from the first Investigational Product (IP) dose until 16 weeks after their last dose. 10.Compliance with maintenance therapy during run-in ≥70%. 11. Blood eosinophils due to subject's stratification and cap for blood eosinophil levels.When any eosinophil cohort is full, subjects in the completed cohort will not be randomised and will be withdrawn from the study. Exclusion criteria: 1. Clinically important pulmonary disease other than COPD or another diagnosed pulmonary or systemic disease associated with elevated peripheral eosinophil counts.

2. Any disorder or major physical impairment that is not stable by Investigator opinion and/or could affect: - subject safety-study findings or their interpretation or subject's ability to complete the entire study duration.

3. Unstable ischemic heart disease, arrhythmia, cardiomyopathy, or other relevant cardiovascular disorder that in Investigator's judgment may put the patient at risk or negatively affect the study outcome.

4. Treatment with systemic corticosteroids and/or antibiotics, and/or hospitalization for a COPD exacerbation within 2 weeks prior to Visit1 or during the enrolment and run-in period.

5. Acute upper or lower respiratory infection requiring antibiotics or antiviral medication within 2 weeks prior to Visit1or during the enrolment and run-in period.

6. Pneumonia within 8 weeks prior to Visit1 or during the enrolment and run-in period.

7. Pregnant, breastfeeding, or lactating women. 8. Risk factors for pneumonia 9. History of anaphylaxis to any other biologic therapy. 10. Long term oxygen therapy with signs and/or symptoms of cor pulmonale, right ventricular failure.

11. Use of immunosuppressive medication within 2 weeks prior to Visit1 and/or during the enrolment and run-in period.

12. Receipt of any investigational non-biologic product within 30 days or 5 half-lives prior to Visit 1.

13. Evidence of active tuberculosis (TB) without an appropriate course of treatment.

14. Lung volume reduction surgery within the 6 months prior to Visit 1. History of partial or total lung resection (single lobe or segmentectomy is acceptable).

15. Asthma as a primary or main diagnosis according to the Global Initiative for Asthma (GINA) guidelines or other accepted guidelines.

16. Previous treatment with benralizumab. 17. Helminth parasitic infection diagnosed within 24 weeks prior to Visit 1.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Placebo administered subcutaneously	Drug: Placebo; Placebo subcutaneously on study week 0 until study week 48 inclusive
Experimental: Benralizumab Arm A; Benralizumab administered subcutaneously	Drug: Benralizumab Arm A; Benralizumab subcutaneously on study week 0 until study week 48 inclusive
Experimental: Benralizumab Arm B; Benralizumab administered subcutaneously	Drug: Benralizumab Arm B; Benralizumab subcutaneously on study week 0 until study week 48 inclusive

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Annual COPD Exacerbation Rate Over 56 Weeks Treatment Comparison for Patients With Baseline EOS>=220/uL	A COPD exacerbation is defined by symptomatic worsening of COPD requiring: Use of systemic corticosteroids for at least 3 days; a single depot injectable dose of corticosteroids will be considered equivalent to a 3-day course of systemic corticosteroids; and/or; Use of antibiotics; and/or; An inpatient hospitalization or death due to COPD Annual COPD exacerbation rate is the number of exacerbations per year. Its raw rate is calculated by number of exacerbations divided by the treatment period and then normalized to an annual rate, and is estimated by negative binomial model. Rate ratio between two treatment groups is also estimated through this model.	From first IP to week 56

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Annual COPD Exacerbation Rate Over 56 Weeks Treatment Comparison for Patients With Baseline EOS<220/uL	A COPD exacerbation is defined by symptomatic worsening of COPD requiring: Use of systemic corticosteroids for at least 3 days; a single depot injectable dose of corticosteroids will be considered equivalent to a 3-day course of systemic corticosteroids; and/or; Use of antibiotics; and/or; An inpatient hospitalization or death due to COPD Annual COPD exacerbation rate is the number of exacerbations per year. Its raw rate is calculated by number of exacerbations divided by the treatment period and then normalized to an annual rate, and is estimated by negative binomial model. Rate ratio between two treatment groups is also estimated through this model.	From first IP to week 56
Mean Change From Baseline to Week 56 in Pre-bronchodilator FEV1 (L) Value for Patients With Baseline EOS>=220/uL	Pre-bronchodilator FEV1 (L) is collected at Weeks 0, 4, 8, 16, 24, 32, 40, 48, and 56. Baseline is the last non-missing value with quality (acceptable or borderline quality grade) prior to the first dose of study treatment.	First IP up to end of treatment Week 56
Mean Change From Baseline in SGRQ Total Score for Patients With Baseline EOS>=220/uL	SGRQ is from 50-item PRO instrument. The SGRQ total score is expressed as a percentage of overall impairment, in which 100% means the worst possible health status and 0 indicates the best possible health status.	First IP up to Week 56
Mean Change From Baseline in CAT Total Score for Patients With Baseline EOS>=220/uL	CAT is an 8-item PRO developed to measure the impact of COPD on health status. The instrument uses semantic differential six-point response scales. A CAT total score is the sum of item responses. Score ranges from 0 to 40 with higher scores indicative of greater COPD impact on health status.	First IP up to Week 56
Mean Change From Baseline in E-RS: COPD Total Score for Patients With Baseline EOS>=220/uL	The E-RS: COPD is an 11-item PRO developed to evaluate the severity of respiratory symptoms of COPD. Summation of E-RS: COPD item responses produces a total score ranging from 0 to 40, with higher scores indicating greater severity.	First IP up to Week 56
Mean Change From Baseline in Total Rescue Medication Use (Number of Puffs Per Day) for Patients With Baseline EOS>=220/uL	The number of rescue medication inhalations and nebulizer treatments taken are recorded by the patient in the eDiary twice daily. Total rescue medication use is the sum of daytime and night-time use.	First IP up to Week 56
Mean Change From Baseline in Proportion of Nights Awakenings Due to Respiratory Symptoms for Patients With Baseline EOS>=220/uL	Change from baseline to week 56 in proportion of nights awakenings due to respiratory symptoms.	First IP up to Week 56
Number of Participants by Number of COPD Exacerbations Based on EXACT-PRO for Patients With Baseline EOS>=220/uL	The EXACT-PRO is a 14-item PRO instrument developed to assess the frequency, severity and duration of COPD exacerbations. Respondents are instructed to complete the electronic diary (eDiary) each evening just prior to bedtime and to answer the questions while onsidering their experiences "today". The daily EXACT-PRO total score has a range of 0-100 with higher scores indicative of greater severity. Exacerbation event frequency is calculated by comparing the baseline with daily total scores. An increase in EXACT-PRO total score ≥9 for 3 days or ≥12 for 2 days indicate an exacerbation event has occurred.	Immediately following first IP up to week 56
Severity of EXACT-PRO for Patients With Baseline EOS>=220/uL	The EXACT-PRO is a 14-item PRO instrument developed to assess the frequency, severity and duration of COPD exacerbations. Respondents are instructed to complete the electronic diary (eDiary) each evening just prior to bedtime and to answer the questions while onsidering their experiences "today". The daily EXACT-PRO total score has a range of 0-100 with higher scores indicative of greater severity. Severity for the study is the highest score of EXACT-PRO.	Immediately following first IP up to week 56
Duration of EXACT-PRO for Patients With Baseline EOS>=220/uL	The EXACT-PRO is a 14-item PRO instrument developed to assess the frequency, severity and duration of COPD exacerbations. Respondents are instructed to complete the electronic diary (eDiary) each evening just prior to bedtime and to answer the questions while onsidering their experiences "today". The daily EXACT-PRO total score has a range of 0-100 with higher scores indicative of greater severity. Event frequency is calculated by comparing the baseline with daily total scores. An increase in EXACT-PRO total score ≥9 for 3 days or ≥12 for 2 days indicate an event has occurred. Calculation of event duration after identification of the following five parameters: 1) onset; 2) three-day rolling average; 3) maximum observed value; 4) threshold for improvement; and 5) recovery. That is, duration of the exacerbation is the time elapse between onset and recovery of the event.	Immediately following first IP up to week 56
Annual EXACT-PRO Exacerbation Rate Over 56 Weeks Treatment Comparison for Patients With Baseline EOS>=220/uL	The EXACT-PRO is a 14-item PRO instrument developed to assess the frequency, severity and duration of COPD exacerbations. Respondents are instructed to complete the electronic diary (eDiary) each evening just prior to bedtime and to answer the questions while onsidering their experiences "today". The daily EXACT-PRO total score has a range of 0-100 with higher scores indicative of greater severity. Event frequency is calculated by comparing the baseline with daily total scores. An increase in EXACT-PRO total score ≥9 for 3 days or ≥12 for 2 days indicate an event has occurred. Annual EXACT-PRO exacerbation rate is the number of exacerbations per year. Its raw rate is calculated by number of exacerbations divided by the treatment period and then normalized to an annual rate, and is estimated by negative binomial model. Rate ratio between two treatment groups is also estimated through this model.	Immediately following first IP up to week 56
Number of Participants Having at Least 1 COPD Exacerbation for Patients With Baseline EOS>=220/uL	A COPD exacerbation is defined by symptomatic worsening COPD requiring systemic corticosteroids, antibiotics, or an inpatient hospitalization/death due to COPD.	Immediately following first IP up to week 56
Time to First COPD Exacerbation	Time to first COPD exacerbation is from the randomization date to the first occurrence of COPD exacerbation	Immediately following first IP up to week 56
Annual COPD Exacerbation Rate Associated With ER or Hospitalization Over 56 Weeks Treatment Comparison for Patients With Baseline EOS>=220/uL	Annual COPD exacerbations rate that result in ER or hospitalization is calculated by number of exacerbations resulting ER or hospitalization divided by the treatment period and then normalized to an annual rate, and is estimated by negative binomial model. Rate ratio between two treatment groups is also estimated through this model.	Immediately following first IP up to week 56
Number of Participants Had COPD-related Healthcare Encounter for Patient With Baseline EOS>=220/uL	Types of healthcare encounter: Hospitalisations (inc. intensive care and/or general care), Emergency department visits, Unscheduled outpatients visits, Home visits, Telephone calls, and ambulance transports.	Immediately following first IP up to week 56
Duration of Study Treatment Administration	Duration of study treatment is calculated from first dose date to last dose date + 1 day.	From first dose date to last dose date, 48 weeks per protocol.
Serum Concentration of Benralizumab	PK serum samples were collected pre-dose at each visit.	Pre-first dose and pre-dose at end of treatment (week 56)
Immunogenicity of Benralizumab	Antidrug antibody (ADA) responses such as ADA prevalence, ADA incidence, ADA persistently positive counts, etc. were presented	Pre-treatment until end of follow-up, week 60 per protocol.

Collaborators and Investigators

• Sponsor: AstraZeneca
• Collaborators: MedImmune LLC

Publications and helpful links

General Publications

• Criner GJ, Celli BR, Singh D, Agusti A, Papi A, Jison M, Makulova N, Shih VH, Brooks L, Barker P, Martin UJ, Newbold P. Predicting response to benralizumab in chronic obstructive pulmonary disease: analyses of GALATHEA and TERRANOVA studies. Lancet Respir Med. 2020 Feb;8(2):158-170. doi: 10.1016/S2213-2600(19)30338-8. Epub 2019 Sep 28.
• Criner GJ, Celli BR, Brightling CE, Agusti A, Papi A, Singh D, Sin DD, Vogelmeier CF, Sciurba FC, Bafadhel M, Backer V, Kato M, Ramirez-Venegas A, Wei YF, Bjermer L, Shih VH, Jison M, O'Quinn S, Makulova N, Newbold P, Goldman M, Martin UJ; GALATHEA Study Investigators; TERRANOVA Study Investigators. Benralizumab for the Prevention of COPD Exacerbations. N Engl J Med. 2019 Sep 12;381(11):1023-1034. doi: 10.1056/NEJMoa1905248. Epub 2019 May 20.

Helpful Links

• Clinical Study protocol
• Statistical Analysis Plan (SAP)

Study record dates

Study Major Dates

• Study Start (Actual): June 13, 2014
• Primary Completion (Actual): April 10, 2018
• Study Completion (Actual): April 10, 2018

Study Registration Dates

• First Submitted: March 26, 2014
• First Submitted That Met QC Criteria: May 13, 2014
• First Posted (Estimate): May 15, 2014

Study Record Updates

• Last Update Posted (Actual): June 13, 2019
• Last Update Submitted That Met QC Criteria: June 12, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: Bronchial Diseases; Respiratory Tract Diseases; Obstructive Lung Diseases; Chronic Obstructive Pulmonary Disease; Lung Disease; COPD Exacerbation
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Anti-Asthmatic Agents; Respiratory System Agents; Benralizumab
• Other Study ID Numbers: D3251C00003