Efficacy and Safety of Benralizumab in Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD) With a History of Frequent Exacerbations (RESOLUTE)

February 20, 2024 updated by: AstraZeneca

A Multicenter, Randomized, Double-blind, Chronic-dosing, Parallel-group, Placebo-controlled Phase 3 Study to Evaluate the Efficacy and Safety of Benralizumab 100 mg in Patients With Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD) With a History of Frequent COPD Exacerbations and Elevated Peripheral Blood Eosinophils (RESOLUTE)

Phase 3 study to evaluate the efficacy and safety of a benralizumab in patients with moderate to very severe COPD with a history of frequent COPD exacerbations and elevated peripheral blood eosinophils (≥300/μL).

Eligible patients must have a history of ≥2 moderate and/or severe COPD exacerbations in the previous year despite receiving triple (ICS/LABA/LAMA) background therapy for at least 3 months and ICS-based dual inhaled treatment for the remainder of the year. Eligible patients must also have an elevated blood eosinophil count.

The treatment period will be of variable duration and will continue until the last patient has the opportunity to complete a minimum of 56 weeks, at which point all patients will complete the study. The primary endpoint will be analyzed at Week 56.

Study Overview

Status

Recruiting

Conditions

Chronic Obstructive Pulmonary Disease

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

642

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: AstraZeneca Clinical Study Information Center
Phone Number: 1-877-240-9479
Email: information.center@astrazeneca.com

Study Locations

Argentina
- - Buenos Aires, Argentina, S2000PBJ
    - Recruiting
    - Research Site
  - Caba, Argentina, C1012AAR
    - Recruiting
    - Research Site
  - Ciudad Autónoma de Buenos Aire, Argentina, C1440BRR
    - Terminated
    - Research Site
  - Ciudad de Buenos Aires, Argentina, 1425
    - Recruiting
    - Research Site
  - Córdoba, Argentina, X5003DCE
    - Recruiting
    - Research Site
  - Florencio Varela, Argentina, 1888
    - Recruiting
    - Research Site
  - Florida, Argentina, B1602DQD
    - Recruiting
    - Research Site
  - Mar del Plata, Argentina, B7600GWV
    - Recruiting
    - Research Site
  - Mendoza, Argentina, M5500GIP
    - Recruiting
    - Research Site
  - Monte Grande, Argentina, B1842
    - Not yet recruiting
    - Research Site
  - San Fernando, Argentina, B1646EBJ
    - Recruiting
    - Research Site
  - San Miguel de Tucuman, Argentina, 4000
    - Recruiting
    - Research Site
Australia
- - Caringbah, Australia, 2229
    - Suspended
    - Research Site
  - Melbourne, Australia, 3004
    - Recruiting
    - Research Site
  - South Brisbane, Australia, 4101
    - Recruiting
    - Research Site
  - Southport, Australia, 4215
    - Recruiting
    - Research Site
  - Spearwood, Australia, 6163
    - Recruiting
    - Research Site
Austria
- - Bad Ischl, Austria, 4820
    - Recruiting
    - Research Site
  - Bludenz, Austria, 6700
    - Recruiting
    - Research Site
  - Feldbach, Austria, A-8330
    - Recruiting
    - Research Site
  - Grieskirchen, Austria, 4710
    - Recruiting
    - Research Site
  - Linz, Austria, 4020
    - Recruiting
    - Research Site
  - Thalheim, Austria, 4600
    - Terminated
    - Research Site
Belgium
- - Edegem, Belgium, 2650
    - Recruiting
    - Research Site
  - Erpent, Belgium, 5101
    - Recruiting
    - Research Site
  - Yvoir, Belgium, 5530
    - Not yet recruiting
    - Research Site
Brazil
- - Blumenau, Brazil, 89030-101
    - Recruiting
    - Research Site
  - Botucatu, Brazil, 18.618-686
    - Recruiting
    - Research Site
  - Florianópolis, Brazil, 88036-800
    - Terminated
    - Research Site
  - Maringa, Brazil, 87015-000
    - Recruiting
    - Research Site
  - Porto Alegre, Brazil, 91350-200
    - Recruiting
    - Research Site
  - Porto Alegre, Brazil, 90610-000
    - Recruiting
    - Research Site
  - Porto Alegre, Brazil, 9002-060
    - Recruiting
    - Research Site
  - Porto Alegre, Brazil, 90020-090
    - Recruiting
    - Research Site
  - Santo Andre, Brazil, 09080-110
    - Recruiting
    - Research Site
  - Sao Bernardo do Campo, Brazil, 09750-420
    - Recruiting
    - Research Site
  - Sao Paulo, Brazil, 05403-000
    - Recruiting
    - Research Site
  - Sorocaba, Brazil, 18040-425
    - Recruiting
    - Research Site
  - Uberlandia, Brazil, 38411-186
    - Withdrawn
    - Research Site
Bulgaria
- - Kozloduy, Bulgaria, 3320
    - Recruiting
    - Research Site
  - Ruse, Bulgaria, 7002
    - Recruiting
    - Research Site
  - Stara Zagora, Bulgaria, 6000
    - Recruiting
    - Research Site
Canada
- - Chicoutimi, Canada, G7H 5H6
    - Suspended
    - Research Site
  - Quebec, Canada, G2J 0C4
    - Recruiting
    - Research Site
  - Quebec, Canada, G1V 4W2
    - Recruiting
    - Research Site
  - Quebec, Canada, G1W 4R4
    - Terminated
    - Research Site
- Alberta
  - Calgary, Alberta, Canada, T3B 0M3
    - Recruiting
    - Research Site
  - Edmonton, Alberta, Canada, T5J 3S9
    - Withdrawn
    - Research Site
- British Columbia
  - Kelowna, British Columbia, Canada, V1Y 3H5
    - Withdrawn
    - Research Site
- NF
  - St. John's, NF, Canada, A1A 3R5
    - Terminated
    - Research Site
- Nova Scotia
  - Bridgewater, Nova Scotia, Canada, B4V 3N2
    - Withdrawn
    - Research Site
  - Lower Sackville, Nova Scotia, Canada, B4C 2S4
    - Withdrawn
    - Research Site
- Ontario
  - Ajax, Ontario, Canada, L1S 2J5
    - Recruiting
    - Research Site
  - Barrie, Ontario, Canada, L4M 6M2
    - Terminated
    - Research Site
  - Sarnia, Ontario, Canada, N7T 4X3
    - Terminated
    - Research Site
  - Stouffville, Ontario, Canada, L4A 1H2
    - Recruiting
    - Research Site
  - Toronto, Ontario, Canada, M5T 3A9
    - Recruiting
    - Research Site
  - Toronto, Ontario, Canada, M9V 4B4
    - Terminated
    - Research Site
- Quebec
  - Montreal, Quebec, Canada, H4A 3J1
    - Suspended
    - Research Site
- Saskatchewan
  - Saskatoon, Saskatchewan, Canada, S7N 0W8
    - Recruiting
    - Research Site
Chile
- - Curico, Chile, 3341643
    - Terminated
    - Research Site
  - Quillota, Chile, 2260000
    - Recruiting
    - Research Site
  - Santiago, Chile, 7500692
    - Recruiting
    - Research Site
  - Santiago, Chile, 7500571
    - Terminated
    - Research Site
  - Santiago, Chile, 8380453
    - Recruiting
    - Research Site
  - Santiago, Chile, 7500698
    - Terminated
    - Research Site
  - Talca, Chile, 3465584
    - Recruiting
    - Research Site
  - Viña del Mar, Chile, 2520997
    - Withdrawn
    - Research Site
China
- - Baotou, China, 14010
    - Recruiting
    - Research Site
  - Beijing, China, 100034
    - Recruiting
    - Research Site
  - Beijing, China, 102218
    - Recruiting
    - Research Site
  - Changsha, China, 410005
    - Recruiting
    - Research Site
  - Changsha, China, 430033
    - Recruiting
    - Research Site
  - Changsha, China, 410015
    - Recruiting
    - Research Site
  - Chengdu, China, 610041
    - Recruiting
    - Research Site
  - Chengdu, China, 610072
    - Withdrawn
    - Research Site
  - Chongqing, China, 402260
    - Recruiting
    - Research Site
  - Ganzhou, China, 341000
    - Recruiting
    - Research Site
  - Guangzhou, China, 510180
    - Recruiting
    - Research Site
  - Guangzhou, China, 510630
    - Recruiting
    - Research Site
  - Guangzhou, China, 510180
    - Withdrawn
    - Research Site
  - Guiyang, China, 550002
    - Recruiting
    - Research Site
  - Haikou, China, 570311
    - Recruiting
    - Research Site
  - Hangzhou, China, 310006
    - Withdrawn
    - Research Site
  - Hebei, China
    - Recruiting
    - Research Site
  - Hefei, China, 230001
    - Recruiting
    - Research Site
  - Hohhot, China, 010017
    - Recruiting
    - Research Site
  - Hohhot, China, 10050
    - Recruiting
    - Research Site
  - Kunming, China, 650032
    - Withdrawn
    - Research Site
  - Linhai, China, 317000
    - Recruiting
    - Research Site
  - Nanchang, China, 330006
    - Recruiting
    - Research Site
  - Nanchang, China, 330006
    - Withdrawn
    - Research Site
  - Nanjing, China, 210011
    - Withdrawn
    - Research Site
  - Nanjing, China, 210012
    - Withdrawn
    - Research Site
  - Shanghai, China, 200032
    - Recruiting
    - Research Site
  - Shanghai, China, 200433
    - Recruiting
    - Research Site
  - Shanghai, China, 200002
    - Recruiting
    - Research Site
  - Shanghai, China, 200240
    - Withdrawn
    - Research Site
  - Shanghai, China, 200092
    - Withdrawn
    - Research Site
  - Shenyang, China, 110015
    - Recruiting
    - Research Site
  - Shenyang, China, 100003
    - Withdrawn
    - Research Site
  - Shenzhen, China, 518020
    - Recruiting
    - Research Site
  - Shenzhen, China, 518039
    - Withdrawn
    - Research Site
  - Shijiazhuang, China, 50051
    - Withdrawn
    - Research Site
  - Suzhou, China, 215000
    - Recruiting
    - Research Site
  - Urumqi, China
    - Recruiting
    - Research Site
  - Wenzhou, China, 325027
    - Recruiting
    - Research Site
  - Wuhan, China, 430030
    - Recruiting
    - Research Site
  - Wuhan, China
    - Recruiting
    - Research Site
  - Xi'an, China, 710061
    - Recruiting
    - Research Site
  - Yangzhou, China, 225000
    - Withdrawn
    - Research Site
  - Yanji, China, 133000
    - Withdrawn
    - Research Site
  - Yinchuan, China, 750001
    - Recruiting
    - Research Site
  - Yinchuan, China, 750004
    - Withdrawn
    - Research Site
  - Yiyang, China, 413000
    - Withdrawn
    - Research Site
  - Zhanjiang, China, 524001
    - Recruiting
    - Research Site
  - Zhengzhou, China, 450003
    - Recruiting
    - Research Site
Colombia
- - Barranquilla, Colombia, 80007
    - Recruiting
    - Research Site
  - Cali, Colombia, 76001000
    - Recruiting
    - Research Site
  - Floridablanca, Colombia, 681004
    - Recruiting
    - Research Site
  - Medellin, Colombia, 5001000
    - Recruiting
    - Research Site
  - Medellin, Colombia, 050621
    - Not yet recruiting
    - Research Site
  - Pereira, Colombia, 660003
    - Recruiting
    - Research Site
  - Rionegro, Colombia, 54048
    - Withdrawn
    - Research Site
  - Zipaquira, Colombia, 200251
    - Recruiting
    - Research Site
Czechia
- - Brandys nad Labem, Czechia, 250 01
    - Active, not recruiting
    - Research Site
  - Jindrichuv Hradec, Czechia, 377 01
    - Completed
    - Research Site
  - Ostrava, Czechia, 708 68
    - Completed
    - Research Site
  - Rokycany, Czechia, 337 22
    - Active, not recruiting
    - Research Site
  - Teplice, Czechia, 415 01
    - Completed
    - Research Site
Denmark
- - Hvidovre, Denmark, 2650
    - Recruiting
    - Research Site
  - København NV, Denmark, 2400
    - Recruiting
    - Research Site
  - Odense C, Denmark, 5000
    - Recruiting
    - Research Site
  - Roskilde, Denmark, 4000
    - Recruiting
    - Research Site
  - Vejle, Denmark, 7100
    - Recruiting
    - Research Site
  - Ålborg, Denmark, 9000
    - Recruiting
    - Research Site
Germany
- - Aachen, Germany, 52074
    - Withdrawn
    - Research Site
  - Bamberg, Germany, 96049
    - Recruiting
    - Research Site
  - Berlin, Germany, 10717
    - Recruiting
    - Research Site
  - Berlin, Germany, 13187
    - Recruiting
    - Research Site
  - Berlin, Germany, 12157
    - Recruiting
    - Research Site
  - Darmstadt, Germany, 64283
    - Recruiting
    - Research Site
  - Hamburg, Germany, 20354
    - Recruiting
    - Research Site
  - Hannover, Germany, D-30173
    - Recruiting
    - Research Site
  - Koblenz, Germany, 56068
    - Recruiting
    - Research Site
  - Köln, Germany, 51069
    - Recruiting
    - Research Site
  - Leipzig, Germany, 04207
    - Recruiting
    - Research Site
  - Leipzig, Germany, 04103
    - Terminated
    - Research Site
  - Leipzig, Germany, 04357
    - Recruiting
    - Research Site
  - Marburg, Germany, 35037
    - Recruiting
    - Research Site
  - Marburg, Germany, 35037
    - Withdrawn
    - Research Site
  - Neu-Isenburg, Germany, 63263
    - Terminated
    - Research Site
  - Peine, Germany, 31224
    - Recruiting
    - Research Site
  - Potsdam, Germany, 14467
    - Completed
    - Research Site
  - Rheine, Germany, 48431
    - Terminated
    - Research Site
  - Warendorf, Germany, 48231
    - Terminated
    - Research Site
Greece
- - Athens, Greece, 11527
    - Recruiting
    - Research Site
  - Athens, Greece, 11527
    - Withdrawn
    - Research Site
  - Athens, Greece, 12462
    - Withdrawn
    - Research Site
  - Athens, Greece, 10676
    - Withdrawn
    - Research Site
  - Exohi Thessaloniki, Greece, 57010
    - Recruiting
    - Research Site
  - Heraklion, Greece, 71110
    - Withdrawn
    - Research Site
  - Ioannina, Greece, 45500
    - Recruiting
    - Research Site
  - Thessaloniki, Greece, 57010
    - Recruiting
    - Research Site
  - Thessaloniki, Greece, 56429
    - Completed
    - Research Site
Hungary
- - Balassagyarmat, Hungary, 2660
    - Recruiting
    - Research Site
  - Budapest, Hungary, 1033
    - Terminated
    - Research Site
  - Edelény, Hungary, 3780
    - Completed
    - Research Site
  - Encs, Hungary, 3860
    - Recruiting
    - Research Site
  - Gödöllő, Hungary, 2100
    - Recruiting
    - Research Site
  - Hajdúnánás, Hungary, 4080
    - Recruiting
    - Research Site
  - Komárom, Hungary, 2900
    - Recruiting
    - Research Site
  - Pécs, Hungary, 7635
    - Terminated
    - Research Site
  - Siófok, Hungary, 8600
    - Terminated
    - Research Site
  - Szeged, Hungary, 6722
    - Terminated
    - Research Site
  - Százhalombatta, Hungary, 2440
    - Recruiting
    - Research Site
  - Törökbálint, Hungary, 2045
    - Terminated
    - Research Site
India
- - Ahmedabad, India, 380006
    - Withdrawn
    - Research Site
  - Ansari Nagar, India, 110 029
    - Withdrawn
    - Research Site
  - Calicut, India, 673 008
    - Recruiting
    - Research Site
  - Chennai, India, 600116
    - Recruiting
    - Research Site
  - Coimbatore, India, 641028
    - Recruiting
    - Research Site
  - Delhi, India, 110029
    - Not yet recruiting
    - Research Site
  - Guntur, India, 522005
    - Recruiting
    - Research Site
  - Hyderabad, India, 500038
    - Recruiting
    - Research Site
  - Jaipur, India, 302039
    - Not yet recruiting
    - Research Site
  - Pune, India, 411047
    - Withdrawn
    - Research Site
  - Thane, India, 401107
    - Recruiting
    - Research Site
  - Vijayawada, India, 520 008
    - Recruiting
    - Research Site
Italy
- - Catanzaro, Italy, 88100
    - Withdrawn
    - Research Site
  - Cona, Italy, 44124
    - Recruiting
    - Research Site
  - Genova, Italy, 16132
    - Recruiting
    - Research Site
  - Milano, Italy, 20157
    - Recruiting
    - Research Site
  - Milano, Italy, 20142
    - Recruiting
    - Research Site
  - Napoli, Italy, 80131
    - Recruiting
    - Research Site
  - Reggio Emilia, Italy, 42123
    - Recruiting
    - Research Site
  - Roma, Italy, 00168
    - Recruiting
    - Research Site
  - Rozzano, Italy, 20089
    - Recruiting
    - Research Site
Japan
- - Chuo-ku, Japan, 103-0022
    - Recruiting
    - Research Site
  - Chuo-ku, Japan, 104-0031
    - Recruiting
    - Research Site
  - Chuo-ku, Japan, 104-0031
    - Terminated
    - Research Site
  - Fukuoka-shi, Japan, 814-0180
    - Recruiting
    - Research Site
  - Himeji-shi, Japan, 672-8064
    - Terminated
    - Research Site
  - Hitachinaka-shi, Japan, 312-0057
    - Recruiting
    - Research Site
  - Joyo-shi, Japan, 610-0113
    - Recruiting
    - Research Site
  - Kasuga-shi, Japan, 816-0813
    - Withdrawn
    - Research Site
  - Kawachinagano-shi, Japan, 586-8521
    - Recruiting
    - Research Site
  - Kishiwada-shi, Japan, 596-8501
    - Recruiting
    - Research Site
  - Kobe-shi, Japan, 650-0047
    - Recruiting
    - Research Site
  - Koto-ku, Japan, 136-0075
    - Recruiting
    - Research Site
  - Kure-shi, Japan, 737-0023
    - Recruiting
    - Research Site
  - Matsusaka-shi, Japan, 515-8544
    - Recruiting
    - Research Site
  - Meguro-ku, Japan, 152-8902
    - Withdrawn
    - Research Site
  - Mizunami-shi, Japan, 509-6134
    - Active, not recruiting
    - Research Site
  - Nagaoka-shi, Japan, 940-2085
    - Recruiting
    - Research Site
  - Nagoya-shi, Japan, 457-8511
    - Recruiting
    - Research Site
  - Nishinomiya-shi, Japan, 663-8501
    - Recruiting
    - Research Site
  - Okayama-shi, Japan, 700-8558
    - Terminated
    - Research Site
  - Osaka-shi, Japan, 531-0073
    - Recruiting
    - Research Site
  - Sagamihara-shi, Japan, 252-0315
    - Recruiting
    - Research Site
  - Sakai-shi, Japan, 591-8555
    - Recruiting
    - Research Site
  - Sakaide-shi, Japan, 762-8550
    - Recruiting
    - Research Site
  - Seto-shi, Japan, 489-8642
    - Recruiting
    - Research Site
  - Shinagawa-ku, Japan, 142-8666
    - Recruiting
    - Research Site
  - Shinagawa-ku, Japan, 140-8522
    - Terminated
    - Research Site
  - Toshima-ku, Japan, 170-0003
    - Recruiting
    - Research Site
  - Toshima-ku, Japan, 170-0002
    - Recruiting
    - Research Site
  - Toshima-ku, Japan, 171-0014
    - Recruiting
    - Research Site
  - Toyonaka-shi, Japan, 560-8552
    - Recruiting
    - Research Site
  - Ueda-shi, Japan, 386-8610
    - Recruiting
    - Research Site
  - Yanagawa-shi, Japan, 832-0059
    - Recruiting
    - Research Site
  - Yokohama-shi, Japan, 223-0059
    - Recruiting
    - Research Site
Korea, Republic of
- - Daegu, Korea, Republic of, 42415
    - Recruiting
    - Research Site
  - Jeonju-si, Korea, Republic of, 54907
    - Recruiting
    - Research Site
  - Seoul, Korea, Republic of, 03312
    - Recruiting
    - Research Site
  - Seoul, Korea, Republic of, 06591
    - Recruiting
    - Research Site
  - Seoul, Korea, Republic of, 05030
    - Recruiting
    - Research Site
  - Seoul, Korea, Republic of, 04401
    - Terminated
    - Research Site
  - Wonju-si, Korea, Republic of, 26426
    - Recruiting
    - Research Site
Mexico
- - Guadalajara, Mexico, 44100
    - Recruiting
    - Research Site
  - Guadalajara, Mexico, 44200
    - Recruiting
    - Research Site
  - Guadalajara, Mexico, 44130
    - Recruiting
    - Research Site
  - Mexico, Mexico, 07760
    - Withdrawn
    - Research Site
  - Monterrey, Mexico, 64460
    - Recruiting
    - Research Site
  - Mérida, Mexico, 97070
    - Recruiting
    - Research Site
  - Veracruz, Mexico, 91910
    - Recruiting
    - Research Site
Netherlands
- - Amersfoort, Netherlands, 3813 TZ
    - Recruiting
    - Research Site
  - Breda, Netherlands, 4818 CK
    - Recruiting
    - Research Site
  - Den Haag, Netherlands, 2512 VA
    - Withdrawn
    - Research Site
  - Leeuwarden, Netherlands, 8934 AD
    - Recruiting
    - Research Site
New Zealand
- - Auckland, New Zealand, 0626
    - Recruiting
    - Research Site
  - Auckland, New Zealand, 1051
    - Recruiting
    - Research Site
  - Christchurch, New Zealand, 8024
    - Recruiting
    - Research Site
  - Dunedin, New Zealand, 9016
    - Recruiting
    - Research Site
  - Hamilton, New Zealand, 3204
    - Recruiting
    - Research Site
Philippines
- - Cavite City, Philippines, 4114
    - Withdrawn
    - Research Site
  - Iloilo City, Philippines, 5000
    - Recruiting
    - Research Site
  - Los Baños, Philippines, 4030
    - Recruiting
    - Research Site
  - Marilao, Philippines, 3019
    - Recruiting
    - Research Site
  - Quezon City, Philippines, 1100
    - Recruiting
    - Research Site
Poland
- - Białystok, Poland, 15-044
    - Recruiting
    - Research Site
  - Chęciny, Poland, 26-060
    - Recruiting
    - Research Site
  - Grodzisk Mazowiecki, Poland, 05-825
    - Recruiting
    - Research Site
  - Katowice, Poland, 40-648
    - Recruiting
    - Research Site
  - Krakow, Poland, 30-727
    - Withdrawn
    - Research Site
  - Ostrowiec Świętokrzyski, Poland, 27-400
    - Recruiting
    - Research Site
  - Poznań, Poland, 60-693
    - Recruiting
    - Research Site
  - Poznań, Poland, 61-578
    - Suspended
    - Research Site
  - Proszowice, Poland, 32-100
    - Terminated
    - Research Site
  - Rzeszów, Poland, 35-051
    - Recruiting
    - Research Site
  - Skierniewice, Poland, 96-100
    - Withdrawn
    - Research Site
  - Warszawa, Poland, 02-793
    - Terminated
    - Research Site
  - Wieluń, Poland, 98-300
    - Terminated
    - Research Site
  - Łódź, Poland, 90-153
    - Recruiting
    - Research Site
Puerto Rico
- - Caguas, Puerto Rico, 00726
    - Recruiting
    - Research Site
  - San Juan, Puerto Rico, 00918
    - Recruiting
    - Research Site
Spain
- - Barcelona, Spain, 08017
    - Recruiting
    - Research Site
  - Hospitalet de Llobregat(Barcel, Spain, 08907
    - Completed
    - Research Site
  - Laredo, Spain, 39770
    - Completed
    - Research Site
  - Madrid, Spain, 28007
    - Recruiting
    - Research Site
  - Madrid, Spain, 28046
    - Recruiting
    - Research Site
  - Madrid, Spain, 28850
    - Recruiting
    - Research Site
  - Málaga, Spain, 29010
    - Recruiting
    - Research Site
  - Santander, Spain, 39008
    - Recruiting
    - Research Site
Sweden
- - Göteborg, Sweden, 413 45
    - Recruiting
    - Research Site
  - Göteborg, Sweden, 413 46
    - Recruiting
    - Research Site
  - Helsingborg, Sweden, 25220
    - Withdrawn
    - Research Site
  - Lund, Sweden, 222 22
    - Recruiting
    - Research Site
  - Malmö, Sweden, 205 02
    - Recruiting
    - Research Site
  - Stockholm, Sweden, 114 46
    - Recruiting
    - Research Site
Turkey
- - Adana, Turkey, 01330
    - Recruiting
    - Research Site
  - Ankara, Turkey, 06
    - Withdrawn
    - Research Site
  - Antalya, Turkey, 07070
    - Withdrawn
    - Research Site
  - Istanbul, Turkey, 34098
    - Recruiting
    - Research Site
  - Izmir, Turkey, 35110
    - Recruiting
    - Research Site
  - Kocaeli, Turkey, 41380
    - Recruiting
    - Research Site
  - Mersin, Turkey, 33343
    - Recruiting
    - Research Site
  - İstanbul, Turkey, 34844
    - Recruiting
    - Research Site
United Kingdom
- - Barnsley, United Kingdom, S75 3DL
    - Recruiting
    - Research Site
  - Birmingham, United Kingdom, B9 5SS
    - Recruiting
    - Research Site
  - Blackpool, United Kingdom, FY2 0JH
    - Recruiting
    - Research Site
  - Bradford, United Kingdom, BD9 6RJ
    - Recruiting
    - Research Site
  - Chertsey, United Kingdom, KT16 0PZ
    - Active, not recruiting
    - Research Site
  - Cottingham, United Kingdom, HU16 5JQ
    - Recruiting
    - Research Site
  - Larbert, United Kingdom, FK5 4WR
    - Withdrawn
    - Research Site
  - Leicester, United Kingdom, LE3 9QP
    - Recruiting
    - Research Site
  - Manchester, United Kingdom, M13 9NQ
    - Recruiting
    - Research Site
  - Oxford, United Kingdom, OX3 7LE
    - Recruiting
    - Research Site
  - Perth, United Kingdom, PH1 1NX
    - Recruiting
    - Research Site
  - Southampton, United Kingdom, SO166YD
    - Recruiting
    - Research Site
  - Stockton-on-Tees, United Kingdom, TS17 6EW
    - Recruiting
    - Research Site
  - Wishaw, United Kingdom, ML2 0DP
    - Recruiting
    - Research Site
United States
- Alabama
  - Montgomery, Alabama, United States, 36116
    - Withdrawn
    - Research Site
- Arizona
  - Surprise, Arizona, United States, 85374
    - Recruiting
    - Research Site
  - Tucson, Arizona, United States, 85723
    - Not yet recruiting
    - Research Site
  - Tucson, Arizona, United States, 85724
    - Withdrawn
    - Research Site
- Arkansas
  - Little Rock, Arkansas, United States, 72209
    - Terminated
    - Research Site
- California
  - Huntington Beach, California, United States, 92647
    - Recruiting
    - Research Site
  - Long Beach, California, United States, 90806
    - Withdrawn
    - Research Site
  - Los Angeles, California, United States, 90048
    - Recruiting
    - Research Site
  - Los Angeles, California, United States, 90033
    - Recruiting
    - Research Site
  - Newport Beach, California, United States, 92663
    - Recruiting
    - Research Site
  - Northridge, California, United States, 91324
    - Recruiting
    - Research Site
  - Northridge, California, United States, 91324
    - Suspended
    - Research Site
  - Palm Springs, California, United States, 92262
    - Recruiting
    - Research Site
  - Palm Springs, California, United States, 92262
    - Terminated
    - Research Site
  - San Diego, California, United States, 92120
    - Withdrawn
    - Research Site
  - San Diego, California, United States, 92103
    - Suspended
    - Research Site
  - Westminster, California, United States, 92683
    - Recruiting
    - Research Site
- Connecticut
  - Stamford, Connecticut, United States, 06902
    - Terminated
    - Research Site
- Delaware
  - Newark, Delaware, United States, 19713
    - Withdrawn
    - Research Site
- Florida
  - Brandon, Florida, United States, 33511
    - Withdrawn
    - Research Site
  - Clearwater, Florida, United States, 33765
    - Recruiting
    - Research Site
  - Daytona Beach, Florida, United States, 32117
    - Terminated
    - Research Site
  - Edgewater, Florida, United States, 32132
    - Terminated
    - Research Site
  - Jacksonville, Florida, United States, 32204
    - Recruiting
    - Research Site
  - Jacksonville, Florida, United States, 32209
    - Recruiting
    - Research Site
  - Kissimmee, Florida, United States, 34746
    - Recruiting
    - Research Site
  - Kissimmee, Florida, United States, 34741
    - Terminated
    - Research Site
  - Leesburg, Florida, United States, 34748
    - Recruiting
    - Research Site
  - Miami, Florida, United States, 33125
    - Recruiting
    - Research Site
  - Orlando, Florida, United States, 32819
    - Recruiting
    - Research Site
  - Pensacola, Florida, United States, 32503
    - Recruiting
    - Research Site
  - Saint Petersburg, Florida, United States, 33707
    - Recruiting
    - Research Site
  - Tampa, Florida, United States, 33607
    - Recruiting
    - Research Site
  - Winter Park, Florida, United States, 32789
    - Recruiting
    - Research Site
- Georgia
  - Columbus, Georgia, United States, 31904
    - Withdrawn
    - Research Site
  - Decatur, Georgia, United States, 30033
    - Withdrawn
    - Research Site
  - Lawrenceville, Georgia, United States, 30046
    - Completed
    - Research Site
  - Rincon, Georgia, United States, 31326
    - Terminated
    - Research Site
  - Woodstock, Georgia, United States, 30189
    - Withdrawn
    - Research Site
- Illinois
  - Chicago, Illinois, United States, 60611
    - Recruiting
    - Research Site
  - Evanston, Illinois, United States, 60201
    - Recruiting
    - Research Site
  - O'Fallon, Illinois, United States, 62269
    - Terminated
    - Research Site
  - Peoria, Illinois, United States, 61636
    - Recruiting
    - Research Site
- Indiana
  - Michigan City, Indiana, United States, 46360
    - Completed
    - Research Site
  - Valparaiso, Indiana, United States, 46383
    - Withdrawn
    - Research Site
- Iowa
  - Council Bluffs, Iowa, United States, 51503
    - Withdrawn
    - Research Site
  - Iowa City, Iowa, United States, 52242
    - Recruiting
    - Research Site
- Kansas
  - Kansas City, Kansas, United States, 66160
    - Recruiting
    - Research Site
- Kentucky
  - Georgetown, Kentucky, United States, 40324
    - Terminated
    - Research Site
  - Lexington, Kentucky, United States, 40502
    - Recruiting
    - Research Site
- Maryland
  - Baltimore, Maryland, United States, 21224
    - Terminated
    - Research Site
  - Columbia, Maryland, United States, 21044
    - Recruiting
    - Research Site
- Massachusetts
  - Boston, Massachusetts, United States, 02215
    - Recruiting
    - Research Site
  - North Dartmouth, Massachusetts, United States, 02747
    - Recruiting
    - Research Site
- Michigan
  - Farmington Hills, Michigan, United States, 48336
    - Recruiting
    - Research Site
- Missouri
  - Chesterfield, Missouri, United States, 63017
    - Withdrawn
    - Research Site
- Nebraska
  - Lincoln, Nebraska, United States, 68510
    - Terminated
    - Research Site
  - Omaha, Nebraska, United States, 68124
    - Terminated
    - Research Site
- New Jersey
  - Brick, New Jersey, United States, 08724
    - Withdrawn
    - Research Site
  - Toms River, New Jersey, United States, 08755
    - Recruiting
    - Research Site
- New York
  - Bronx, New York, United States, 10461
    - Recruiting
    - Research Site
  - Bronx, New York, United States, 10455
    - Withdrawn
    - Research Site
  - Buffalo, New York, United States, 14215
    - Recruiting
    - Research Site
  - New Windsor, New York, United States, 12553
    - Recruiting
    - Research Site
  - Potsdam, New York, United States, 13676
    - Withdrawn
    - Research Site
- North Carolina
  - Burlington, North Carolina, United States, 27215
    - Terminated
    - Research Site
  - Chapel Hill, North Carolina, United States, 27517
    - Withdrawn
    - Research Site
  - Charlotte, North Carolina, United States, 28277
    - Recruiting
    - Research Site
  - Charlotte, North Carolina, United States, 28287
    - Recruiting
    - Research Site
  - Elizabeth City, North Carolina, United States, 27909
    - Recruiting
    - Research Site
  - Gastonia, North Carolina, United States, 28054
    - Recruiting
    - Research Site
  - Huntersville, North Carolina, United States, 28078
    - Withdrawn
    - Research Site
  - Mooresville, North Carolina, United States, 28117
    - Terminated
    - Research Site
  - New Bern, North Carolina, United States, 28562
    - Recruiting
    - Research Site
  - Wilmington, North Carolina, United States, 28401
    - Recruiting
    - Research Site
  - Winston-Salem, North Carolina, United States, 27103
    - Recruiting
    - Research Site
- North Dakota
  - Fargo, North Dakota, United States, 58104
    - Withdrawn
    - Research Site
- Ohio
  - Cincinnati, Ohio, United States, 45220
    - Recruiting
    - Research Site
  - Cleveland, Ohio, United States, 44106
    - Recruiting
    - Research Site
  - Cleveland, Ohio, United States, 44106
    - Withdrawn
    - Research Site
  - Columbus, Ohio, United States, 43215
    - Recruiting
    - Research Site
- Oklahoma
  - Oklahoma City, Oklahoma, United States, 73106
    - Terminated
    - Research Site
- Oregon
  - Happy Valley, Oregon, United States, 97086
    - Withdrawn
    - Research Site
  - Medford, Oregon, United States, 97504
    - Completed
    - Research Site
- Pennsylvania
  - Doylestown, Pennsylvania, United States, 18901
    - Withdrawn
    - Research Site
  - DuBois, Pennsylvania, United States, 15801
    - Recruiting
    - Research Site
  - Philadelphia, Pennsylvania, United States, 19140
    - Recruiting
    - Research Site
  - Pittsburgh, Pennsylvania, United States, 15213
    - Recruiting
    - Research Site
  - Smithfield, Pennsylvania, United States, 15478
    - Recruiting
    - Research Site
- South Carolina
  - Charleston, South Carolina, United States, 29407
    - Withdrawn
    - Research Site
  - Greenville, South Carolina, United States, 29615
    - Withdrawn
    - Research Site
  - Mount Pleasant, South Carolina, United States, 29464
    - Terminated
    - Research Site
  - North Charleston, South Carolina, United States, 29406
    - Recruiting
    - Research Site
  - Rock Hill, South Carolina, United States, 29732
    - Recruiting
    - Research Site
  - Spartanburg, South Carolina, United States, 29303
    - Withdrawn
    - Research Site
- South Dakota
  - Rapid City, South Dakota, United States, 57702
    - Recruiting
    - Research Site
- Tennessee
  - Chattanooga, Tennessee, United States, 37404
    - Recruiting
    - Research Site
  - Franklin, Tennessee, United States, 37067
    - Recruiting
    - Research Site
  - Hendersonville, Tennessee, United States, 37075
    - Recruiting
    - Research Site
  - Johnson City, Tennessee, United States, 37601
    - Recruiting
    - Research Site
- Texas
  - Amarillo, Texas, United States, 79106
    - Recruiting
    - Research Site
  - Amarillo, Texas, United States, 79124
    - Recruiting
    - Research Site
  - Cypress, Texas, United States, 77429
    - Suspended
    - Research Site
  - Dallas, Texas, United States, 75390
    - Recruiting
    - Research Site
  - Fort Worth, Texas, United States, 76104
    - Recruiting
    - Research Site
  - Houston, Texas, United States, 77079
    - Terminated
    - Research Site
  - Kerrville, Texas, United States, 78028
    - Recruiting
    - Research Site
  - San Antonio, Texas, United States, 78258
    - Recruiting
    - Research Site
  - Spring, Texas, United States, 77380
    - Recruiting
    - Research Site
  - Tomball, Texas, United States, 77375
    - Terminated
    - Research Site
  - Weatherford, Texas, United States, 76086
    - Withdrawn
    - Research Site
- Utah
  - Salt Lake City, Utah, United States, 84102
    - Recruiting
    - Research Site
- Vermont
  - White River Junction, Vermont, United States, 05009
    - Recruiting
    - Research Site
- Virginia
  - Abingdon, Virginia, United States, 24210
    - Completed
    - Research Site
  - Salem, Virginia, United States, 24153
    - Recruiting
    - Research Site
  - Williamsburg, Virginia, United States, 23188
    - Terminated
    - Research Site
- Washington
  - Everett, Washington, United States, 98208
    - Recruiting
    - Research Site
  - Everett, Washington, United States, 98208
    - Suspended
    - Research Site
  - Spokane, Washington, United States, 99204
    - Terminated
    - Research Site
- West Virginia
  - Morgantown, West Virginia, United States, 26505
    - Recruiting
    - Research Site
- Wisconsin
  - Cudahy, Wisconsin, United States, 53110
    - Recruiting
    - Research Site
  - Milwaukee, Wisconsin, United States, 53295
    - Not yet recruiting
    - Research Site
Vietnam
- - Hanoi, Vietnam, 100000
    - Recruiting
    - Research Site
  - Ho Chi Minh, Vietnam, 700000
    - Recruiting
    - Research Site
  - Ho Chi Minh city, Vietnam, 700000
    - Recruiting
    - Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

Description

Inclusion Criteria:

Provision of informed consent
Age 40 to 85 years
Male and/or female.
Current or former smoker with a tobacco history of ≥10 pack-years.
History of moderate to very severe COPD with a post-bronchodilator FEV1/FVC<0.70 and FEV1 ≤65% of predicted normal value.
Documented history of 2 or more COPD exacerbations that required treatment with systemic corticosteroids and/or hospitalization within 52 weeks prior to enrollment.
1. Exacerbations treated with antibiotics alone are excluded unless accompanied by treatment with systemic corticosteroids and/or hospitalization.
2. Hospitalization is defined as an inpatient admission ≥24 hours
3. Previous exacerbations should be confirmed to have occurred while on stable triple therapy for COPD.
4. At least one qualifying COPD exacerbation should occur while on stable uninterrupted triple therapy prior to enrolment.
Documented use of triple (ICS/LABA/LAMA) background therapy for COPD for ≥3 months immediately prior to enrollment.
1. Treatment with at least double inhaled therapy containing ICS (e.g. ICS/LABA or ICS/LAMA) for the remaining of 52 weeks prior to enrolment. Use of LABA/LAMA is allowed if ICS cannot be tolerated.
2. ICS in a dose approved for COPD or equivalent to ≥250 mcg of fluticasone propionate daily.
3. Total cumulative duration of not being on double or triple background therapy must not exceed 2 months.
4. Stable therapy/doses for the last 3 months prior to randomization.
Blood eosinophil count ≥300/μL at screening and documented historical eosinophil count of ≥150/μL within 52 weeks of enrollment (or repeated testing during run-in).
CAT total score ≥15 at Visit 1.
Negative pregnancy test for females of childbearing potential (WOCBP) at Visit 1.
Women of childbearing potential (WOCBP) must agree to use a highly effective method of birth control from enrollment throughout the study and within 12 weeks after last dose of IP.

Women not of childbearing potential are defined as women who are either permanently sterilized or postmenopausal (confirmed by FSH test for women <50 years).

Exclusion Criteria:

Clinically important pulmonary disease other than COPD
Current diagnosis of asthma, prior history of asthma or asthma-COPD overlap according to GINA/GOLD. Childhood history of asthma is allowed and defined as asthma diagnosed and resolved before the age of 18.
Radiological findings of a respiratory disease other than COPD contributing to respiratory symptoms. Solitary pulmonary nodules without appropriate follow up or findings of acute infection.
Another pulmonary or systemic disease associated with elevated peripheral eosinophil counts.
Any unstable disorder that could affect patient safety, study findings or the patient's ability to complete the study.
Any clinically significant abnormal findings in physical examination, vital signs, ECG, laboratory tests could affect patient safety, study findings or the patient's ability to complete the study.
Cor pulmonale and/or right ventricular failure.
Long-term treatment with oxygen >4.0 L/min and/or oxyhemoglobin saturation <89% while breathing supplemental oxygen.
Use of any non-invasive positive pressure ventilation device (NIPPV). Note: use of CPAP for Sleep Apnea Syndrome is allowed.
Known immunodeficiency disorder, including positive HIV-1/2 testing.
Active liver disease. Chronic stable hepatitis B and C (including positive HBsAg or hepatitis C antibody testing), or other stable chronic liver disease are acceptable.
ALT or AST ≥3 times the upper limit of normal, confirmed by repeated testing during the run-in period.
Helminth parasitic infection within 24 weeks prior to enrollment, not treated or failed to respond to standard of care therapy.
Alcohol or drug abuse within the past year, which may compromise the study data.
Malignancy, current or within the past 5 years, except for adequately treated non invasive basal cell and squamous cell carcinoma of the skin and cervical carcinoma-in-situ treated with apparent success more than 1 year prior to Visit 1. Suspected malignancy or undefined neoplasms.
Evidence of active tuberculosis, as judged by investigator. Patients with a recent (within 2 years) first-time or newly positive PPD or Quantiferon test need to complete an appropriate course of treatment before enrollment. Evaluation will be according to the local standard of care.
Participation, or planned participation, in intensive COPD rehabilitation program (maintenance phase of a rehabilitation is allowed).
History of surgical or endoscopic lung volume reduction within the 6 months prior to enrollment. History of partial or total lung resection (single lobe or segmentectomy is acceptable).
Scheduled major surgical procedure during the study. Minor elective procedures are allowed.
History of anaphylaxis to any biologic therapy or vaccine.
Receipt of blood products or immunoglobulins within 30 days prior to randomization.
Receipt of marketed or investigational biologic product within 4 months or 5 half-lives prior to randomization, whichever is longer. Exception: Patients on stable therapy for 3 months before randomization who intend to stay on treatment throughout the study with marketed biologic products that are not likely to interfere with the safety assessment and/or efficacy of benralizumab, for example, for the treatment of osteoporosis, migraine, pain, diabetes, obesity, ocular, cardiovascular, or metabolic diseases, can participate in the study.
Receipt of live attenuated vaccines 30 days prior to randomization.
Chronic use of immunosuppressive medication or expected need for chronic use during the study.
Chronic use of antibiotics if duration of treatment is <9 months prior to randomization. Chronic macrolide or other antibiotic therapy is allowed provided the patient has been on stable dose/regimen for ≥9 months prior to randomization and has had ≥2 COPD exacerbations while on stable therapy.
Receipt of any investigational non-biologic product within 30 days or 5 half-lives prior to enrollment.
Receipt of benralizumab within 12 months prior to enrollment.
Known history of allergy or reaction to any component of the IP formulation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Benralizumab Administrated subcutaneously (SC) every 4 weeks for the first 3 doses, then every 8 weeks	Biological: Benralizumab Benralizumab solution for injection in accessorized prefilled syringe (APFS) will be administered subcutaneously (SC) every 4 weeks for the first 3 doses - Weeks 0, 4 and 8, and then every 8 weeks until the end of treatment.
Placebo Comparator: Placebo Administrated subcutaneously every 4 weeks for the first 3 doses, then every 8 weeks	Biological: Placebo Matching placebo will be administered subcutaneously with accessorized prefilled syringe (APFS) every 4 weeks for the first 3 doses - Weeks 0, 4 and 8, and then every 8 weeks until the end of treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Annualized rate of moderate or severe COPD exacerbations Time Frame: Over first 56 weeks	Moderate or severe COPD exacerbation is defined by symptomatic worsening of COPD requiring: Use of systemic corticosteroids for at least 3 days; and/or Use of antibiotics; and/or An inpatient hospitalization or death due to COPD	Over first 56 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Annualized rate of severe COPD exacerbations Time Frame: Minimum of 1 year and an average of 2 years	A severe COPD exacerbation is defined by symptomatic worsening of COPD requiring an inpatient hospitalization or results in death due to COPD	Minimum of 1 year and an average of 2 years
Annualized rate of COPD exacerbations that are associated with an emergency room/emergency department visit or a hospitalization Time Frame: Minimum of 1 year and an average of 2 years		Minimum of 1 year and an average of 2 years
Time to first COPD exacerbation Time Frame: During first 56 weeks		During first 56 weeks
Change from baseline in SGRQ total and domain scores Time Frame: up to 56 weeks	St. George's Respiratory Questionnaire (SGRQ)	up to 56 weeks
Change from baseline in E-RS:COPD total and domain scores Time Frame: up to 56 weeks	Evaluating Respiratory Symptoms in COPD (E-RS:COPD)	up to 56 weeks
Change from baseline in pre-dose/pre-bronchodilator FEV1 Time Frame: up to 56 weeks	FEV1 is the Forced expiratory volume in one second at study site	up to 56 weeks
All cause and respiratory-related mortality rate Time Frame: Minimum of 1 year and an average of 2 years		Minimum of 1 year and an average of 2 years
Annual rate of hospitalizations due to COPD Time Frame: Minimum of 1 year and an average of 2 years		Minimum of 1 year and an average of 2 years
Serum benralizumab concentration as a measure of pharmacokinetics Time Frame: up to 56 weeks		up to 56 weeks
Anti-drug antibodies (ADA) as a measure of immunogenicity Time Frame: up to 56 weeks		up to 56 weeks
Change from baseline in CAT total score Time Frame: up to 56 weeks	Chronic Obstructive Pulmonary Disease assessment tool (CAT)	up to 56 weeks
Length of hospital stay Time Frame: Minimum of 1 year and an average of 2 years		Minimum of 1 year and an average of 2 years
ICU (Intensive Care Unit) days Time Frame: Minimum of 1 year and an average of 2 years		Minimum of 1 year and an average of 2 years
Annual rate of hospitalizations and emergency department visits combined Time Frame: Minimum of 1 year and an average of 2 years		Minimum of 1 year and an average of 2 years
Annual rate of unscheduled outpatient visits including unscheduled visits to study sites Time Frame: Minimum of 1 year and an average of 2 years		Minimum of 1 year and an average of 2 years
Annual rate of unscheduled healthcare encounters Time Frame: Minimum of 1 year and and average of 2 years		Minimum of 1 year and and average of 2 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety and tolerability of benralizumab in patients with moderate to very severe COPD Time Frame: Minimum of 1 year and average of 2 years	AEs, vital signs, clinical laboratory, and ECG	Minimum of 1 year and average of 2 years

Collaborators and Investigators

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

Sponsor

AstraZeneca

Investigators

Principal Investigator: Gerard Criner, MD, Temple University School of Medicine, 3401 North Broad Street, Suite 745 PP, Philadelphia, PA 19140

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 26, 2019

Primary Completion (Estimated)

June 27, 2025

Study Completion (Estimated)

June 27, 2025

Study Registration Dates

First Submitted

July 16, 2019

First Submitted That Met QC Criteria

August 9, 2019

First Posted (Actual)

August 12, 2019

Study Record Updates

Last Update Posted (Actual)

February 21, 2024

Last Update Submitted That Met QC Criteria

February 20, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

D3251C00014
2019-001800-39 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment.

IPD Sharing Time Frame

AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles.

IPD Sharing Access Criteria

When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access.

IPD Sharing Supporting Information Type

STUDY_PROTOCOL
SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Terminated

Efficacy and Safety Study of the Use of Benralizumab for Patients With Moderate to Severe Atopic Dermatitis

Atopic Dermatitis

United States, France, Korea, Republic of, Spain, Czechia, Bulgaria, Australia, Poland
AstraZeneca
MedImmune LLC

Completed

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

Moderate to Very Severe Chronic Obstructive Pulmonary Disease

United States, Canada, Germany, Italy, Netherlands, Spain, United Kingdom, Poland, Japan, Austria, Korea, Republic of, Russian Federation, South Africa, Czechia, Hungary, Romania, Switzerland
MedImmune LLC
MedImmune Ltd

Completed

Study to Evaluate the Efficacy and Safety of MEDI-563 in Adults With Uncontrolled Asthma

Asthma

United States, Brazil, Bulgaria, Mexico, Peru, Poland, Russian Federation, Argentina, Canada, Colombia
Instituto de Investigación Sanitaria de la Fundación...

Completed

Interaction Between Benralizumab and Basophils in Eosinophilic Asthma (BASEAS)

Asthma; Eosinophilic

Spain
AstraZeneca

Completed

RANS. Study in Patients With Severe Eosinophilic Asthma and Nasal Polyps. (RANS)

Nasal Polyps | Severe Eosinophilic Asthma

United States, France, Italy, Spain, Germany, Japan
Jonathan A. Bernstein, MD

Completed

Treatment of Chronic Urticarial Unresponsive to H1-antihistamines With an Anti-IL5Ralpha Monoclonal Antibody

Chronic Idiopathic Urticaria

United States
AstraZeneca

Completed

A Study of the Safety and Effectiveness of Benralizumab to Treat Patients With Severe Uncontrolled Asthma. (ANDHI)

Asthma

United States, Austria, Belgium, Canada, Denmark, Finland, France, Germany, Italy, Netherlands, Norway, Spain, Sweden, United Kingdom

Efficacy and Safety of Benralizumab in Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD) With a History of Frequent Exacerbations (RESOLUTE)

Study Overview

Status

Conditions

Intervention / Treatment

Study Type

Enrollment (Estimated)

Phase

Contacts and Locations

Study Contact

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Other Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Investigators

Publications and helpful links

Helpful Links

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Estimated)

Study Completion (Estimated)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

IPD Plan Description

IPD Sharing Time Frame

IPD Sharing Access Criteria

IPD Sharing Supporting Information Type

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

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Clinical Trials on Benralizumab

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