Randomised Clinical Trial to Investigate Efficacy and Safety of Benralizumab 30 mg SC as an add-on Therapy in Uncontrolled Eosinophilic Asthma Patients Treated With Medium-dose ICS-LABA Compared to Conventional Escalation to High-dose ICS-LABA Treatment
Start Date
3/28/2025
Completion Date
11/3/2028
Summary
This study evaluates the efficacy and safety of benralizumab as an add-on therapy in uncontrolled eosinophilic asthma participants treated with medium-dose ICS-LABA compared to the conventional treatment step of escalation of inhaled therapy to high-dose ICS-LABA.
Detailed Description
This is a randomized, double-blind, active-controlled, parallel group global study designed to investigate the efficacy and safety of adding fixed-dose benralizumab (30 mg), administered subcutaneously (SC) every 4 weeks for the first 3 doses and then every 8 weeks for participants with a history of eosinophilic asthma, who remain uncontrolled on medium-dose Inhaled corticosteroid-Long-acting β2-agonists (ICS-LABA) with or without other asthma controller(s) (with the exception of oral corticosteroids), compared to the conventional treatment step of escalation of inhaled therapy to high-dose ICS-LABA plus placebo (benralizumab).
Eligibility Criteria
Age Range: 12 years to 75 years
Interventions
ICS-LABA
benralizumab
Placebo for Benralizumab
Conditions
Locations
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Chandler, Arizona 85224
United States
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Sun City, Arizona 85351
United States
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Tucson, Arizona 85704
United States
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Bakersfield, California 93301
United States
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Inglewood, California 90301
United States
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Modesto, California 95355
United States
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Newport Beach, California 92663
United States
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Pasadena, California 91101
United States
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Denver, Colorado 80206
United States
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Cape Coral, Florida 33990
United States
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Hialeah, Florida 33015
United States
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Lauderdale Lakes, Florida 33313
United States
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Leesburg, Florida 34748
United States
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Miami, Florida 33122
United States
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Miami, Florida 33155
United States
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Miami, Florida 33175
United States
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Orlando, Florida 32819
United States
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Plantation, Florida 33324
United States
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Tampa, Florida 33607
United States
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Winter Park, Florida 32789
United States
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Ann Arbor, Michigan 48109
United States
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Henderson, Nevada 89052
United States
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Northfield, New Jersey 08225
United States
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Union City, New Jersey 07087
United States
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New Hyde Park, New York 11042
United States
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The Bronx, New York 10459
United States
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Oklahoma City, Oklahoma 73103
United States
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Oklahoma City, Oklahoma 73111
United States
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DuBois, Pennsylvania 15801
United States
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Warwick, Rhode Island 02886
United States
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Greenville, South Carolina 29607
United States
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Houston, Texas 77099
United States
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McKinney, Texas 75069
United States
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San Antonio, Texas 78251
United States
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Dimitrovgrad, 6400
Bulgaria
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Haskovo, 6300
Bulgaria
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Pleven, 5800
Bulgaria
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Plovdiv, 4002
Bulgaria
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Plovdiv, 4023
Bulgaria
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Rousse, 7002
Bulgaria
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Sofia, 1142
Bulgaria
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Sofia, 1431
Bulgaria
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Stara Zagora, 6000
Bulgaria
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Stara Zagora, 6000
Bulgaria
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Edmonton, Alberta T6G 2C8
Canada
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Kamloops, British Columbia V2C 5T1
Canada
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Vancouver, British Columbia V5Z 1M9
Canada
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Ajax, Ontario L1S 2J5
Canada
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Toronto, Ontario M5T 3A9
Canada
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Windsor, Ontario N8X 1T3
Canada
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Québec, Quebec G1G 3Y8
Canada
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Sainte-Foy, Quebec G1V 4G5
Canada
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Beijing, 100020
China
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Beijing, 100044
China
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Beijing, 102218
China
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Changsha, 410004
China
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Chongqing, 400042
China
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Fuzhou, 350001
China
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Fuzhou, 350005
China
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Fuzhou, 350008
China
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Guangzhou, 510120
China
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Guangzhou, 510180
China
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Hangzhou, 31000
China
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Hangzhou, 310014
China
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Hefei, 230061
China
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Huizhou, 516002
China
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Jinan, 250021
China
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Linyi, 276100
China
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Ningbo, 315020
China
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Qinhuangdao,
China
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Shanghai, 200080
China
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Shanghai, 200433
China
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Wenzhou, 325027
China
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Wuhan, 430030
China
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Xuzhou, 221000
China
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Yinchuan, 750004
China
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Zhengzhou, 450000
China
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Bayonne, 64109
France
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Créteil, 94010
France
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La Tronche, 38043
France
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Lyon, 69317
France
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Montpellier, 34295
France
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Pessac, F-33604
France
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Suresnes, 92150
France
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Toulouse, 31059
France
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Villeurbanne, 69100
France
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Berlin, 10367
Germany
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Berlin, 10717
Germany
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Bonn, 53119
Germany
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Cottbus, 03050
Germany
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Delitzsch, 4509
Germany
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Frankfurt am Main, 60389
Germany
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Geesthacht, 21502
Germany
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Hemer, 58675
Germany
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Landsberg, 86899
Germany
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Langen, 63225
Germany
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Lübeck, 23552
Germany
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Mönchengladbach, 41063
Germany
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München, 81377
Germany
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München-Pasing, 81241
Germany
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Neu-Isenburg, 63263
Germany
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Wiesbaden, 65183
Germany
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Witten, 58452
Germany
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Zossen, 15806
Germany
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Hong Kong, 999077
Hong Kong
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Pok Fu Lam, 999077
Hong Kong
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Shatin, 0000
Hong Kong
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Ballinasloe, H53 T971
Ireland
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Cork, T12 DFK4
Ireland
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Dublin, D15 X40D
Ireland
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Moneymore, A92 VW28
Ireland
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Bari, 70124
Italy
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Bergamo, 24127
Italy
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Brescia, 25123
Italy
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Cagliari, 09122
Italy
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Catanzaro, 88100
Italy
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Genoa, 16132
Italy
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Milan, 20122
Italy
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Modena, 41124
Italy
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Montebelluna, 31044
Italy
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Naples, 80131
Italy
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Roma, 00161
Italy
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Roma, 00168
Italy
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Rozzano, 20089
Italy
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Verona, 37124
Italy
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Lørenskog, N-1478
Norway
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Alcorcón, 28922
Spain
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Alzira (Valencia), 46600
Spain
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Badalona, 08916
Spain
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Barakaldo, 48902
Spain
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Barcelona, 08025
Spain
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Barcelona, 08035
Spain
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Burgos, 09006
Spain
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Cáceres, 10003
Spain
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Granada, 18014
Spain
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Jerez de la Frontera, 11407
Spain
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Lugo, 27003
Spain
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Madrid, 28034
Spain
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Madrid, 28041
Spain
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Madrid, 28050
Spain
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Marbella, 29600
Spain
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Marbella, 29603
Spain
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Málaga, 29010
Spain
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Mérida, 06800
Spain
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Palma de Mallorca, 7120
Spain
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Santander, 39008
Spain
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Aarau, 5001
Switzerland
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Basel, 4031
Switzerland
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Lausanne, 1011
Switzerland
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Sankt Gallen, 9007
Switzerland
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Sion, 1951
Switzerland
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Belfast, BT9 7AB
United Kingdom
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Birmingham, B9 5SS
United Kingdom
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Bradford, BD9 6RJ
United Kingdom
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Bristol, BS10 5NB
United Kingdom
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Chorley, PR7 1PP
United Kingdom
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Leeds, LS9 7TF
United Kingdom
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Liverpool, L7 8XP
United Kingdom
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Nottingham, NG7 2UH
United Kingdom
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Portsmouth, PO6 3LY
United Kingdom