- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02258542
A Safety Extension Study to Evaluate the Safety and Tolerability of Benralizumab (MEDI-563) in Asthmatic Adults and Adolescents on Inhaled Corticosteroid Plus LABA (BORA)
A Multicentre, Double-blind, Randomized, Parallel Group, Phase 3 Safety Extension Study to Evaluate the Safety and Tolerability of Benralizumab (MEDI-563) in Asthmatic Adults and Adolescents on Inhaled Corticosteroid Plus Long-acting β2 Agonist (BORA)
Study Overview
Detailed Description
After a minimum of 1200 patients have been enrolled in this study, subsequent patients (up to a maximum of 2200 total for the study), who complete a minimum of 16 weeks, and no more than 40 weeks, in this study, will be given the option to transition to an open-label safety extension study, Study D3250C00037 (MELTEMI).
Adolescent patients, patients from Japan and South Korea, and any patient who chooses not to enter Study D3250C00037 will remain in this study through IPD or EOT and FU.
At the time of the first interim analysis in Japanese patients, the study regimen for all patients will become unblinded to AstraZeneca for data analysis purposes. Study conduct and blinding at the site and patient level will remain unchanged.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Buenos Aires, Argentina, C1414AIF
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Buenos Aires, Argentina, 1121
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Caba, Argentina, C1425BEN
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Caba, Argentina, C1056ABJ
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Caba, Argentina, C1431FWO
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Ciudad Autónoma de Bs. As., Argentina, 1426
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Concepción del Uruguay, Argentina, 3260
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Corrientes, Argentina, 3400
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Córdoba, Argentina, X5003DCE
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Florida, Argentina, 1138
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Godoy Cruz, Argentina
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La Plata, Argentina, B1902COS
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Mar del Plata, Argentina, B7600GNY
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Mendoza, Argentina, 5500
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Mendoza, Argentina, M5500GIP
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Nueve de julio, Argentina, B6500EZL
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Ranelagh, Argentina, 1886
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Rosario, Argentina, S2000DEJ
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San Miguel de Tucuman, Argentina, 4000
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Bedford Park, Australia, 5042
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Box Hill, Australia, 3128
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Clayton, Australia, 3168
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Concord, Australia, 2139
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Frankston, Australia, 3199
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Nedlands, Australia, 6009
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New Lambton Heights, Australia, 2305
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Parkville, Australia, 3050
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Prahran, Australia, 3004
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Randwick, Australia, 2031
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Woolloongabba, Australia, 4102
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Porto Alegre, Brazil, 90610-000
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Porto Alegre, Brazil, 91350-200
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Porto Alegre, Brazil, 90035074
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Santo Andre, Brazil, 09080-110
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Sao Paulo, Brazil, 05403-000
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Sorocaba, Brazil, 18040-425
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São Paulo, Brazil, 04323-062
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Dupnitsa, Bulgaria, 2600
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Pazardzhik, Bulgaria, 4400
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Pernik, Bulgaria, 2300
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Petrich, Bulgaria, 2850
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Pleven, Bulgaria, 5800
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Ruse, Bulgaria, 7002
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Samokov, Bulgaria, 2000
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Sliven, Bulgaria, 8800
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Sofia, Bulgaria, 1002
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Sofia, Bulgaria, 1152
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Stara Zagora, Bulgaria, 6003
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Varna, Bulgaria, 9000
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Velingrad, Bulgaria, 4600
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Vratsa, Bulgaria, 3000
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Yambol, Bulgaria, 8600
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Quebec, Canada, G1G 3Y8
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Quebec, Canada, G1V 4G5
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Alberta
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Calgary, Alberta, Canada, T2N 4Z6
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Sherwood Park, Alberta, Canada, T8L 0N2
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British Columbia
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Vancouver, British Columbia, Canada, V5Z 1M9
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Vancouver, British Columbia, Canada, V6Z 1Y6
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Ontario
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Burlington, Ontario, Canada, L7N 3V2
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Hamilton, Ontario, Canada, L8N 4A6
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Ottawa, Ontario, Canada, K1G 6C6
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Quebec
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Montreal, Quebec, Canada, H4A 3J1
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Montreal, Quebec, Canada, H4J 1C5
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Montreal, Quebec, Canada, H2W 1T8
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St Charles Borromee, Quebec, Canada, J6E 2B4
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Quillota, Chile, 2260000
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Santiago, Chile, 8207257
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Talcahuano, Chile, 4270918
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Valparaiso, Chile, 2341131
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Viña del Mar, Chile, 2520594
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Jindrichuv Hradec, Czechia, 377 01
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Karlovy Vary, Czechia, 360 17
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Ostrava, Czechia, 728 80
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Plzen, Czechia, 30460
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Praha, Czechia, 130 00
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Rokycany, Czechia, 337 22
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Strakonice, Czechia, 38601
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Teplice, Czechia, 415 01
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Brest Cedex, France, 29609
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Dijon Cedex, France, 21079
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Le Kremlin Bicêtre, France, 94275
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Le Mans Cedex, France, 72037
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Lyon Cedex 4, France, 69317
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Marseille, France, 13015
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Montpellier, France, 34295
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Paris, France, 75018
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Pau Cedex, France, 64046
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Pringy Cedex, France, 74374
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Saint Pierre, France, 97448
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Strasbourg Cedex, France, 67091
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Toulouse CEDEX 09, France, 31059
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Aschaffenburg, Germany, 63739
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Bamberg, Germany, 96049
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Berlin, Germany, 10367
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Berlin, Germany, 10717
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Berlin, Germany, 10787
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Berlin, Germany, 12203
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Bonn, Germany, 53123
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Frankfurt, Germany, 60596
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Frankfurt am Main, Germany, 60596
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Frankfurt/Main, Germany, 60389
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Geesthacht, Germany, 21502
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Grosshansdorf, Germany, 22927
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Hamburg, Germany, 22299
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Hannover, Germany, 30625
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Hannover, Germany, D-30173
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Hannover, Germany, 30167
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Herford, Germany, 32049
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Leipzig, Germany, 04103
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Leipzig, Germany, 04207
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Leipzig, Germany, 04275
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Mainz Am Rhein, Germany, 55131
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München, Germany, 80639
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München, Germany, 80539
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Neu-Isenburg, Germany, 63263
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Rostock, Germany, 18057
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Rüdersdorf, Germany, 15562
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Witten, Germany, 58452
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Asahi-shi, Japan, 289-2511
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Chiyoda-ku, Japan, 102-0083
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Chuo-ku, Japan, 103-0022
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Fukuoka-shi, Japan, 811-1394
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Hiroshima-shi, Japan, 732-0052
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Itabashi-ku, Japan, 173-8610
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Itabashi-ku, Japan, 174-0065
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Kagoshima-shi, Japan, 890-0064
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Kishiwada-shi, Japan, 596-8501
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Kobe-shi, Japan, 653-0013
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Kokubunji-shi, Japan, 185-0014
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Matsue-shi, Japan, 690-8556
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Minato-ku, Japan, 105-0003
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Mizunami-shi, Japan, 509-6134
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Niigata-shi, Japan, 950-2085
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Obihiro-shi, Japan, 080-0013
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Oita-shi, Japan, 870-0021
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Ota-shi, Japan, 373-0807
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Sagamihara-shi, Japan, 252-0315
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Sakai-shi, Japan, 591-8037
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Sakaide-shi, Japan, 762-8550
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Sapporo-shi, Japan, 060-0033
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Sapporo-shi, Japan, 064-0807
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Sendai-shi, Japan, 983-8520
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Setagaya-ku, Japan, 158-0097
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Shibuya-ku, Japan, 150-0013
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Shinagawa-ku, Japan, 142-8666
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Sumida-ku, Japan, 130-8587
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Takamatsu-shi, Japan, 761-7073
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Toshima-ku, Japan, 170-0003
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Tsukubo-gun, Japan, 701-0304
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Yokohama-shi, Japan, 236-0024
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Yokohama-shi, Japan, 231-8682
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Yokohama-shi, Japan, 234-0054
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Anyang-si, Korea, Republic of, 14068
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Bucheon-si, Korea, Republic of, 14584
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Busan, Korea, Republic of, 49201
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Busan, Korea, Republic of, 602-702
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Cheongju-si, Korea, Republic of, 362-804
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Gwangju, Korea, Republic of, 61469
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Incheon, Korea, Republic of, 21431
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Incheon, Korea, Republic of, 405-760
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Jeju-si, Korea, Republic of, 690-767
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Seoul, Korea, Republic of, 03722
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Seoul, Korea, Republic of, 05505
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Seoul, Korea, Republic of, 03080
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Seoul, Korea, Republic of, 135-710
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Seoul, Korea, Republic of, 06591
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Seoul, Korea, Republic of, 03312
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Seoul, Korea, Republic of, 08308
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Seoul, Korea, Republic of, 150-713
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Seoul, Korea, Republic of, 07985
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Seoul, Korea, Republic of, 05030
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Suwon-si, Korea, Republic of, 16499
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Cusco, Peru
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Lima, Peru, LIMA 27
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Lima, Peru, LIMA 1
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Lima, Peru, Lima 18
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Lima, Peru, 41
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Lima, Peru, LIMA 33
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Lima, Peru, L41
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Lima, Peru, 15102
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Lima, Peru, LIMA 21
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Iloilo City, Philippines, 5000
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Lipa City, Philippines, 4217
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Quezon City, Philippines, 1101
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Aleksandrów Łódzki, Poland, 95-070
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Białystok, Poland, 15-044
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Białystok, Poland, 15-430
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Białystok, Poland, 15-879
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Białystok, Poland, 15-276
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Bielsko Biala, Poland, 43-316
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Bydgoszcz, Poland, 85-168
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Bystra Śląska, Poland, 43-360
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Dobre Miasto, Poland, 11-040
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Gdańsk, Poland, 80-952
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Gdańsk, Poland, 80-433
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Giżycko, Poland, 11-500
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Gorzów Wlkp, Poland, 66-400
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Grodzisk Mazowiecki, Poland, 05-825
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Karczew, Poland, 05-480
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Katowice, Poland, 40-081
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Koszalin, Poland, 75-679
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Kościan, Poland, 64-000
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Kraków, Poland, 31-159
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Kraków, Poland, 31-011
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Kraków, Poland, 31-033
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Kraków, Poland, 31-455
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Lubin, Poland, 59-300
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Lublin, Poland, 20-718
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Lublin, Poland, 20-552
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Lublin, Poland, 20-089
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Ostrów Wielkopolski, Poland, 63-400
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Poznań, Poland, 60-685
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Poznań, Poland, 60-693
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Poznań, Poland, 60-823
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Poznań, Poland, 60-214
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Proszowice, Poland, 32-100
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Ruda Slaska, Poland, 41-709
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Rzeszów, Poland, 35-205
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Rzeszów, Poland, 35-612
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Skierniewice, Poland, 96-100
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Sosnowiec, Poland, 41-200
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Szczecin, Poland, 70-111
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Tarnów, Poland, 33-100
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Trzebnica, Poland, 55-100
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Warszawa, Poland, 01-138
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Warszawa, Poland, 01-868
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Wieluń, Poland, 98-300
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Wołomin, Poland, 05-200
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Wroclaw, Poland, 53-201
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Wrocław, Poland, 53-301
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Wrocław, Poland, 50-220
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Wrocław, Poland, 51-162
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Łódź, Poland, 90-141
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Łódź, Poland, 90-242
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Łódź, Poland, 91-103
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Żnin, Poland, 88-400
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Bragadiru, Romania, 077025
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Bucharest, Romania, 030303
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Bucharest, Romania, 71593
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Constanta, Romania, 900002
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Deva, Romania, 330061
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Iasi, Romania, 700115
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Chelyabinsk, Russian Federation, 454106
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Ekaterinburg, Russian Federation, 620039
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Ekaterinburg, Russian Federation, 620109
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Ivanovo, Russian Federation, 153005
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Izhevsk, Russian Federation, 426063
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Kazan, Russian Federation, 420012
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Moscow, Russian Federation, 123995
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Moscow, Russian Federation, 115682
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Moscow, Russian Federation, 121309
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Moscow, Russian Federation, 109240
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Nizhny Novgorod, Russian Federation, 603126
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Novosibirsk, Russian Federation, 630008
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Novosibirsk, Russian Federation, 630084
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Pyatigorsk, Russian Federation, 357500
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Ryazan, Russian Federation, 390026
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Saint - Petersburg, Russian Federation, 196657
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Saint Petersburg, Russian Federation, 194354
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Saint Petersburg, Russian Federation, 195257
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Saint Petersburg, Russian Federation, 196084
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Saint-Petersburg, Russian Federation, 196084
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Saratov, Russian Federation, 410053
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Smolensk, Russian Federation, 214019
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St. Petersburg, Russian Federation, 196247
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St. Petersburg, Russian Federation, 197022
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St. Petersburg, Russian Federation, 194356
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St.Petersburg, Russian Federation, 194354
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StPetersburg, Russian Federation, 193312
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Tomsk, Russian Federation, 634063
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Vladikavkaz, Russian Federation, 362007
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Vladimir, Russian Federation, 600023
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Volgograd, Russian Federation, 400001
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Volgograd, Russian Federation, 400131
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Yekaterinburg, Russian Federation, 620149
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Cape Town, South Africa, 7764
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Durban, South Africa, 4092
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Mowbray, South Africa, 7700
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Stanger, South Africa, 4450
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Barcelona, Spain, 08036
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Barcelona, Spain, 08025
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Lugo, Spain, 27004
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Madrid, Spain, 28040
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Málaga, Spain, 29010
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Oviedo, Spain, 33011
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Palma de Mallorca, Spain, 07010
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Sagunto(Valencia), Spain, 46520
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Salamanca, Spain, 37007
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Valencia, Spain, 46017
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Valencia, Spain, 46015
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Göteborg, Sweden
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Lund, Sweden, 22185
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Adana, Turkey, 01330
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Ankara, Turkey, 06230
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Bursa, Turkey, 16059
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Istanbul, Turkey, 34098
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Izmir, Turkey, 35100
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Mersin, Turkey, 33343
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İstanbul, Turkey, 34844
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Chernivtsi, Ukraine, 58000
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Dnipropetrovsk, Ukraine, 49007
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Ivano-Frankivsk, Ukraine, 76012
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Kharkiv, Ukraine, 61039
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Kharkiv, Ukraine, 61058
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Kharkiv, Ukraine, 61106
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Kharkiv, Ukraine, 61035
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Kharkiv, Ukraine, 61022
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Kyiv, Ukraine, 03680
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Kyiv, Ukraine, 04201
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Lutsk, Ukraine, 43000
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Uzhgorod, Ukraine, 88000
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Vinnytsia, Ukraine, 21029
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Birmingham, United Kingdom, B9 5SS
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Bradford, United Kingdom, BD9 6RJ
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Cambridge, United Kingdom, CB2 0QQ
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Chertsey, United Kingdom, KT16 0PZ
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Chester, United Kingdom, CH2 1UL
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Cottingham, United Kingdom, HU16 5JQ
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Darlington, United Kingdom, DL3 6HX
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Glasgow, United Kingdom, G12 0YN
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Liverpool, United Kingdom, L7 8XP
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Manchester, United Kingdom, M23 9LT
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Nottingham, United Kingdom, NG5 1PB
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Plymouth, United Kingdom, PL6 8DH
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Portsmouth, United Kingdom, PO6 3LY
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Soham, United Kingdom, CB7 5JD
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Somerset, United Kingdom, BS26 2BJ
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Stevenage, United Kingdom, SG1 4AB
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Stockton, United Kingdom, TS19 8PE
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Alabama
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Andalusia, Alabama, United States, 36420
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Birmingham, Alabama, United States, 35209
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Scottsboro, Alabama, United States, 35768
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Arizona
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Glendale, Arizona, United States, 85306
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Phoenix, Arizona, United States, 85012
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California
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Alhambra, California, United States, 91801
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Bakersfield, California, United States, 93301
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Newport Beach, California, United States, 92663
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Redondo Beach, California, United States, 90277
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Roseville, California, United States, 95661
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Sacramento, California, United States, 95825
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San Jose, California, United States, 95117
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Stockton, California, United States, 95204
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Walnut Creek, California, United States, 94598
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Westminster, California, United States, 92683
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Woodland, California, United States, 95695
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Colorado
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Colorado Springs, Colorado, United States, 80907
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Denver, Colorado, United States, 80206
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Wheat Ridge, Colorado, United States, 80033
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Connecticut
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New Haven, Connecticut, United States, 06520
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Florida
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Brandon, Florida, United States, 33511
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Clearwater, Florida, United States, 33765
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Cutler Bay, Florida, United States, 33189
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Doral, Florida, United States, 33172
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Hialeah, Florida, United States, 33012
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Hialeah, Florida, United States, 33013
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Homestead, Florida, United States, 33030
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Miami, Florida, United States, 33126
- Research Site
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Miami, Florida, United States, 33176
- Research Site
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Miami, Florida, United States, 33134
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Miami, Florida, United States, 33144
- Research Site
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Miami, Florida, United States, 33135
- Research Site
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Miami, Florida, United States, 33015
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Ocala, Florida, United States, 34471-4463
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Orlando, Florida, United States, 32825
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Orlando, Florida, United States, 32819
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Tampa, Florida, United States, 33607
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Winter Park, Florida, United States, 32789
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Georgia
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Albany, Georgia, United States, 31707
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Gainesville, Georgia, United States, 30501
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Lawrenceville, Georgia, United States, 30046
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Illinois
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Gurnee, Illinois, United States, 60031
- Research Site
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Normal, Illinois, United States, 61761
- Research Site
-
-
Iowa
-
Iowa City, Iowa, United States, 52242
- Research Site
-
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Kentucky
-
Fort Mitchell, Kentucky, United States, 41017
- Research Site
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Louisville, Kentucky, United States, 40215
- Research Site
-
-
Louisiana
-
Covington, Louisiana, United States, 70433
- Research Site
-
-
Maine
-
Bangor, Maine, United States, 04401
- Research Site
-
-
Maryland
-
Baltimore, Maryland, United States, 21236
- Research Site
-
-
Massachusetts
-
Quincy, Massachusetts, United States, 02169
- Research Site
-
-
Michigan
-
Farmington Hills, Michigan, United States, 48336
- Research Site
-
Farmington Hills, Michigan, United States, 48334
- Research Site
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Flint, Michigan, United States, 48504
- Research Site
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Traverse City, Michigan, United States, 49684
- Research Site
-
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Minnesota
-
Rochester, Minnesota, United States, 55905
- Research Site
-
Saint Paul, Minnesota, United States, 55130
- Research Site
-
-
Missouri
-
Saint Louis, Missouri, United States, 63143
- Research Site
-
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New Jersey
-
Northfield, New Jersey, United States, 08225
- Research Site
-
Union, New Jersey, United States, 07083
- Research Site
-
-
New Mexico
-
Albuquerque, New Mexico, United States, 87131
- Research Site
-
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New York
-
Bronx, New York, United States, 10461
- Research Site
-
New York, New York, United States, 10016
- Research Site
-
Staten Island, New York, United States, 10305
- Research Site
-
-
North Carolina
-
Durham, North Carolina, United States, 27705
- Research Site
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Wilmington, North Carolina, United States, 28401
- Research Site
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Winston-Salem, North Carolina, United States, 27104
- Research Site
-
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Ohio
-
Cincinnati, Ohio, United States, 45231
- Research Site
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Middleburg Heights, Ohio, United States, 44130
- Research Site
-
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Oklahoma
-
Oklahoma City, Oklahoma, United States, 73112
- Research Site
-
Oklahoma City, Oklahoma, United States, 73120
- Research Site
-
Oklahoma City, Oklahoma, United States, 73103
- Research Site
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Oklahoma City, Oklahoma, United States, 73131
- Research Site
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Tulsa, Oklahoma, United States, 74136
- Research Site
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Pennsylvania
-
Jefferson Hills, Pennsylvania, United States, 15025
- Research Site
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Philadelphia, Pennsylvania, United States, 19140
- Research Site
-
Pittsburgh, Pennsylvania, United States, 15213
- Research Site
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Pittsburgh, Pennsylvania, United States, 15241
- Research Site
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Rhode Island
-
Warwick, Rhode Island, United States, 02886
- Research Site
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South Carolina
-
Hodges, South Carolina, United States, 29653
- Research Site
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South Dakota
-
Rapid City, South Dakota, United States, 57702
- Research Site
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Texas
-
Arlington, Texas, United States, 76018
- Research Site
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Boerne, Texas, United States, 78006
- Research Site
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Dallas, Texas, United States, 75225
- Research Site
-
Dallas, Texas, United States, 75230
- Research Site
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Dallas, Texas, United States, 75235
- Research Site
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Houston, Texas, United States, 77058
- Research Site
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Houston, Texas, United States, 77099
- Research Site
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Houston, Texas, United States, 77081
- Research Site
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Houston, Texas, United States, 77083
- Research Site
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McAllen, Texas, United States, 78504
- Research Site
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McKinney, Texas, United States, 75069
- Research Site
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San Antonio, Texas, United States, 78229
- Research Site
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Splendora, Texas, United States, 77372
- Research Site
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Utah
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Provo, Utah, United States, 84604
- Research Site
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Salt Lake City, Utah, United States, 84112
- Research Site
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Virginia
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Abingdon, Virginia, United States, 24210
- Research Site
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Falls Church, Virginia, United States, 22044
- Research Site
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Wisconsin
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Greenfield, Wisconsin, United States, 53228
- Research Site
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Madison, Wisconsin, United States, 53792
- Research Site
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Milwaukee, Wisconsin, United States, 53226
- Research Site
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Hanoi, Vietnam, 100000
- Research Site
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Ho Chi Minh, Vietnam, 700000
- Research Site
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion criteria
- Informed consent (and/or assent as applicable locally) for study participation must be obtained prior to any study related procedures being performed (local regulations are to be followed in determining the assent/consent requirements for children and parent(s)/guardian(s)) and according to international guidelines and/or applicable European Union guidelines.
- Female and male patients who completed the double-blind treatment period in a predecessor study on benralizumab or matching placebo.
- Women of childbearing potential (WOCBP) must agree to use an effective form of birth control throughout the study duration and for 16 weeks after last dose of Investigational Product (IP).
- For WOCBP only: Have a negative urine pregnancy test prior to administration of Investigational Product (IP) at Visit 1.
- All male patients who are sexually active must agree to use a double barrier method of contraception (condom with spermicide) from the first dose of IP until 16 weeks after their last dose.
Exclusion criteria
Any disorder including but not limited to cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, haematological, psychiatric or major physical impairment that is not stable in the opinion of the Investigator and could:
- Affect the safety of the patient throughout the study
- Influence the findings of the studies or their interpretations
- Impede the patient's ability to complete the entire duration of study
- A helminth parasitic infection diagnosed during a predecessor study that has either not been treated, has been incompletely treated or has failed to respond to standard of care therapy
- Any clinically significant change in physical examination, vital signs, electrocardiogram (ECG), haematology, clinical chemistry, or urinalysis during a predecessor study which in the opinion of the investigator may put the patient at risk because of his/her participation in the study, or may influence the results of the study, or interfere with the patient's ability to complete the entire duration of the study
- Current malignancy or malignancy that developed during a predecessor study (subjects that had basal cell carcinoma, localized squamous cell carcinoma of the skin which was resected for cure, or in situ carcinoma of the cervix that has been treated/cured will not be excluded).
- Receipt of live attenuated vaccines within 30 days prior to initiation of treatment in this study, during the treatment period, and for 16 weeks (5 half-lives) after the last dose of the investigational product
- Receipt of immunoglobulin or blood products within 30 days prior to Visit 1
- Planned major surgical procedures during the conduct of the study
- Previous participation in the present study
- Concurrent enrolment in another clinical trial
- AstraZeneca staff involved in the planning and/or conduct of the study
- Employees of the study centre or any other individuals involved with the conduct of the study or immediate family members of such individuals
- Patients with major protocol deviations in any of the predecessor studies at the discretion of the Sponsor
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Benralizumab Arm A
Benralizumab administered subcutaneously
|
Benralizumab administered subcutaneously
|
Experimental: Benralizumab Arm B
Benralizumab administered subcutaneously
|
Benralizumab administered subcutaneously
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in Basophils, Full Analysis Set, Excluding MELTEMI Patients
Time Frame: Week 56
|
Change from baseline in hematologic lab parameter of Basophils.
|
Week 56
|
Change From Baseline in Basophils, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA)
Time Frame: Week 108
|
Change from baseline in hematologic lab parameter of Basophils.
|
Week 108
|
Change From Baseline in Leukocytes, Full Analysis Set, Excluding MELTEMI Patients
Time Frame: Week 56
|
Change from baseline in hematologic lab parameter of Leukocytes.
|
Week 56
|
Change From Baseline in Leukocytes, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA)
Time Frame: Week 108
|
Change from baseline in hematologic lab parameter of Leukocytes.
|
Week 108
|
Change From Baseline in Lymphocytes, Full Analysis Set, Excluding MELTEMI Patients
Time Frame: Week 56
|
Change from baseline in hematologic lab parameter of Lymphocytes.
|
Week 56
|
Change From Baseline in Lymphocytes, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA)
Time Frame: Week 108
|
Change from baseline in hematologic lab parameter of Lymphocytes.
|
Week 108
|
Change From Baseline in Neutrophils, Full Analysis Set, Excluding MELTEMI Patients
Time Frame: Week 56
|
Change from baseline in hematologic lab parameter of Neutrophils.
|
Week 56
|
Change From Baseline in Neutrophils, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA)
Time Frame: Week 108
|
Change from baseline in hematologic lab parameter of Neutrophils.
|
Week 108
|
Change From Baseline in Eosinophils, Full Analysis Set, Excluding MELTEMI Patients
Time Frame: Week 56
|
Change from baseline in hematologic lab parameter of Eosinophils.
|
Week 56
|
Change From Baseline in Eosinophils, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA)
Time Frame: Week 108
|
Change from baseline in hematologic lab parameter of Eosinophils.
|
Week 108
|
Change From Baseline in Alanine Aminotransferase (ALT), Full Analysis Set, Excluding MELTEMI Patients
Time Frame: Week 56
|
Change from baseline in chemistry tests ALT.
|
Week 56
|
Change From Baseline in ALT, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA)
Time Frame: Week 108
|
Change from baseline in hematologic lab parameter of ALT.
|
Week 108
|
Change From Baseline in Aspartate Aminotransferase (AST), Full Analysis Set, Excluding MELTEMI Patients
Time Frame: Week 56
|
Change from baseline in chemistry tests AST.
|
Week 56
|
Change From Baseline in AST, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA)
Time Frame: Week 108
|
Change from baseline in hematologic lab parameter of AST.
|
Week 108
|
Change From Baseline in Bilirubin, Full Analysis Set, Excluding MELTEMI Patients
Time Frame: Week 56
|
Change from baseline in chemistry test Bilirubin.
|
Week 56
|
Change From Baseline in Bilirubin, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA)
Time Frame: Week 108
|
Change from baseline in hematologic lab parameter of Bilirubin.
|
Week 108
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Overall Patients With Asthma Exacerbations During Study Period
Time Frame: From week 0 to week 56 in study treatment period and through the follow up period (16 weeks from day of last dose)
|
Annual asthma exacerbation rate, where an asthma exacerbation is defined by a worsening of asthma requiring the use of systemic corticosteroids for at least 3 days, and/or an in patient hospitalization, and/or an emergency department or urgent care visit
|
From week 0 to week 56 in study treatment period and through the follow up period (16 weeks from day of last dose)
|
Number of Overall Patients With Asthma Exacerbations During Study Period, Adolescents Only (SIROCCO/CALIMA)
Time Frame: From week 0 to week 108 in study treatment period and through the follow up period (16 weeks from day of last dose)
|
Annual asthma exacerbation rate, where an asthma exacerbation is defined by a worsening of asthma requiring the use of systemic corticosteroids for at least 3 days, and/or an in patient hospitalization, and/or an emergency department or urgent care visit
|
From week 0 to week 108 in study treatment period and through the follow up period (16 weeks from day of last dose)
|
Change From Baseline in Pre-bronchodilator FEV1 (L)
Time Frame: Week 56
|
Change from baseline to Week 56 in Pre-bronchodilator Forced expiratory volume in 1 second (FEV1).
|
Week 56
|
Change From Baseline in Pre-bronchodilator FEV1 (L), Adolescents Only (SIROCCO/CALIMA)
Time Frame: Week 108
|
Change from baseline to Week 108 in Pre-bronchodilator Forced expiratory volume in 1 second (FEV1).
|
Week 108
|
Change From Baseline in Post-bronchodilator FEV1 (L)
Time Frame: Week 56
|
Change from baseline to Week 56 in Post-bronchodilator Forced expiratory volume in 1 second (FEV1).
|
Week 56
|
Change From Baseline in Post-bronchodilator FEV1 (L), Adolescents Only (SIROCCO/CALIMA)
Time Frame: Week 108
|
Change from baseline to Week 108 in Post-bronchodilator Forced expiratory volume in 1 second (FEV1).
|
Week 108
|
Change From Baseline in Asthma Control Questionnaire (ACQ) as a Measure of Asthma Control in Overall Patients
Time Frame: Week 56
|
Asthma Control Questionnaire 6 (ACQ-6) contains 1 bronchodilator use question and 5 symptom questions.
Questions were weighted equally and scored from 0 (totally controlled) to 6 (severely uncontrolled).
The mean ACQ-6 score was the mean of the responses.
|
Week 56
|
Change From Baseline in Asthma Control Questionnaire (ACQ) as a Measure of Asthma Control in Overall Patients, Adolescents Only (SIROCCO/CALIMA)
Time Frame: Week 108
|
Asthma Control Questionnaire 6 (ACQ-6) contains 1 bronchodilator use question and 5 symptom questions.
Questions were weighted equally and scored from 0 (totally controlled) to 6 (severely uncontrolled).
The mean ACQ-6 score was the mean of the responses.
|
Week 108
|
Change From Baseline in Total Score of Asthma Related and General Health-related Quality of Life Questionnaire (AQLQ(S)+12)
Time Frame: Week 56
|
Standardised Asthma Quality of Life Questionnaire for 12 Years and Older (AQLQ(S)+12) comprises 4 separate domains (symptoms, activity limitations, emotional function, and environmental stimuli).
It contains 32 questions on a 7 point scale ranging from 7 (no impairment) to 1 (severe impairment); total score is an average of all questions.
An increase in score indicates improvement.
|
Week 56
|
Change From Baseline in Total Score of Asthma Related and General Health-related Quality of Life Questionnaire (AQLQ(S)+12), Adolescents Only (SIROCCO/CALIMA)
Time Frame: Week 108
|
Standardised Asthma Quality of Life Questionnaire for 12 Years and Older (AQLQ(S)+12) comprises 4 separate domains (symptoms, activity limitations, emotional function, and environmental stimuli).
It contains 32 questions on a 7 point scale ranging from 7 (no impairment) to 1 (severe impairment); total score is an average of all questions.
An increase in score indicates improvement.
|
Week 108
|
Change of Blood Eosinophil Levels' Measurement in Overall Patients
Time Frame: Week 56
|
Change from baseline to Week 56 in Blood eosinophils
|
Week 56
|
Change of Blood Eosinophil Levels' Measurement in Adolescents Patients (SIROCCO/CALIMA).
Time Frame: Week 108
|
Change from baseline to Week 108 in Blood eosinophils.
|
Week 108
|
Change From Baseline in EQ-5D-5L Visual Analog Scale
Time Frame: Week 56
|
The questionnaire included a visual analog scale (VAS) score, where the patient was asked to rate current health status on a scale of 0 to 100, with 0 being the worst imaginable health state; thus, an increase in VAS score indicated improvement.
|
Week 56
|
Change From Baseline in EQ-5D-5L Visual Analog Scale, Adolescents Only (SIROCCO/CALIMA)
Time Frame: Week 108
|
The questionnaire included a VAS, where the patient was asked to rate current health status on a scale of 0 to 100, with 0 being the worst imaginable health state; thus, an increase in VAS score indicated improvement.
|
Week 108
|
Work Productivity Loss in Adults, Using Work Productivity and Activity Impairment Questionnaire (WPAI)
Time Frame: Week 68
|
The WPAI+CIQ is a 10-item questionnaire that assesses productivity and activity impairment over the previous week.
The questionnaire includes hours missed from work/school due to asthma, degree health affected productivity while at work/school, as well as the degree to which health affected regular activities other than work or school.
The questionnaire related to the previous 7 days.
Work productivity loss is calculated with sum of hours missed at work due to health problem and hours that affected due to health problem at work, divided by sum of hours missed due to health problem and hours actually worked, presented by percentage.
|
Week 68
|
Work Productivity Loss in Adults, Using Work Productivity and Activity Impairment Questionnaire (WPAI), Adolescents Only (SIROCCO/CALIMA)
Time Frame: Week 108
|
The WPAI+CIQ is a 10-item questionnaire that assesses productivity and activity impairment over the previous week.
The questionnaire includes hours missed from work/school due to asthma, degree health affected productivity while at work/school, as well as the degree to which health affected regular activities other than work or school.
The questionnaire related to the previous 7 days.
Work productivity loss is calculated with sum of hours missed at work due to health problem and hours that affected due to health problem at work, divided by sum of hours missed due to health problem and hours actually worked, presented by percentage.
|
Week 108
|
Classroom Productivity Loss Using Classroom Impairment Questionnaire (CIQ)
Time Frame: Week 56
|
The WPAI (+CIQ) is a 10-item questionnaire that assesses productivity and activity impairment over the previous week.
The questionnaire includes hours missed from work/school due to asthma, degree health affected productivity while at work/school, as well as the degree to which health affected regular activities other than work or school.
The questionnaire related to the previous 7 days.
Classroom productivity loss is calculated with sum of hours missed for classes due to health problem and hours that affected due to health problem in classes, divided by sum of hours missed due to health problem and hours actually attended classes, presented by percentage.
|
Week 56
|
Classroom Productivity Loss Using Classroom Impairment Questionnaire (CIQ), Adolescents Only (SIROCCO/CALIMA)
Time Frame: Week 108
|
The WPAI (+CIQ) is a 10-item questionnaire that assesses productivity and activity impairment over the previous week.
The questionnaire includes hours missed from work/school due to asthma, degree health affected productivity while at work/school, as well as the degree to which health affected regular activities other than work or school.
The questionnaire related to the previous 7 days.
Classroom productivity loss is calculated with sum of hours missed for classes due to health problem and hours that affected due to health problem in classes, divided by sum of hours missed due to health problem and hours actually attended classes, presented by percentage.
|
Week 108
|
Activity Impairment (%), Using Work Productivity and Activity Impairment Questionnaire (WPAI)
Time Frame: Week 68
|
The WPAI+CIQ is a 10-item questionnaire that assesses productivity and activity impairment over the previous week.
The questionnaire includes hours missed from work/school due to asthma, degree health affected productivity while at work/school, as well as the degree to which health affected regular activities other than work or school.
The questionnaire related to the previous 7 days.
The WPAI+CIQ outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity.
|
Week 68
|
Activity Impairment (%), Using Work Productivity and Activity Impairment Questionnaire (WPAI), Adolescents Only (SIROCCO/CALIMA)
Time Frame: Week 108
|
The WPAI+CIQ is a 10-item questionnaire that assesses productivity and activity impairment over the previous week.
The questionnaire includes hours missed from work/school due to asthma, degree health affected productivity while at work/school, as well as the degree to which health affected regular activities other than work or school.
The questionnaire related to the previous 7 days.
The WPAI+CIQ outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity.
|
Week 108
|
Number of Patients Who Had Health Care Encounter (ie, Hospitalization, Emergency Department Visits, Urgent Care Visits, and All Other Outpatient Visits Due to Asthma) During Study Period
Time Frame: From week 0 to week 68 in study treatment period and through the follow up period (16 weeks from day of last dose)
|
Hospitalizations, Emergency department (ED) visits, urgent care visits and all other outpatient visits due to asthma
|
From week 0 to week 68 in study treatment period and through the follow up period (16 weeks from day of last dose)
|
Number of Patients Who Had Health Care Encounter (ie, Hospitalization, Emergency Department Visits, Urgent Care Visits, and All Other Outpatient Visits Due to Asthma) During Study Period, Adolescents Only (SIROCCO/CALIMA)
Time Frame: Baseline and Week 108
|
Hospitalizations, ED visits, urgent care visits and all other outpatient visits due to asthma
|
Baseline and Week 108
|
Pre-dose Benralizumab Concentration in Serum During the Treatment Phase of the Safety Study
Time Frame: Week 0 and Week 56
|
Endpoint: Pharmacokinetic (PK) parameters
|
Week 0 and Week 56
|
Pre-dose Benralizumab Concentration in Serum During the Treatment Phase of the Safety Study, Adolescents Only (SIROCCO/CALIMA)
Time Frame: Baseline and Week 108
|
Endpoint: Pharmacokinetic (PK) parameters
|
Baseline and Week 108
|
Number of Patients With Anti-drug Antibodies (ADA) Responses During the Study
Time Frame: From week 0 to week 56 in study treatment period (adults) and plus 16 weeks the follow up period; From week 0 to week 108-week in study treatment period (adolescents) and plus 16 weeks the follow up period
|
Assessments for the presence of ADA and neutralizing antibody (nAb) throughout study
|
From week 0 to week 56 in study treatment period (adults) and plus 16 weeks the follow up period; From week 0 to week 108-week in study treatment period (adolescents) and plus 16 weeks the follow up period
|
Number of Patients With Anti-drug Antibodies (ADA) Responses During the Study, Adolescents Only (SIROCCO/CALIMA)
Time Frame: From week 0 to week 108 study treatment period (adults) and plus 16 weeks the follow up period; From week 0 to week 108-week in study treatment period (adolescents) and plus 16 weeks the follow up period
|
Assessments for the presence of ADA and nAb throughout study
|
From week 0 to week 108 study treatment period (adults) and plus 16 weeks the follow up period; From week 0 to week 108-week in study treatment period (adolescents) and plus 16 weeks the follow up period
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: William W. Busse, M.D., Professor of Medicine, Allergy, Pulmonary, and Critical Care Medicine 600 Highland Avenue; Madison, WI
Publications and helpful links
General Publications
- Busse WW, Bleecker ER, FitzGerald JM, Ferguson GT, Barker P, Brooks L, Olsson RF, Martin UJ, Goldman M; BORA study investigators. Benralizumab for adolescent patients with severe, eosinophilic asthma: Safety and efficacy after 3 years of treatment. J Allergy Clin Immunol. 2021 Jul;148(1):266-271.e2. doi: 10.1016/j.jaci.2021.02.009. Epub 2021 Feb 17.
- Busse WW, Bleecker ER, FitzGerald JM, Ferguson GT, Barker P, Sproule S, Olsson RF, Martin UJ, Goldman M; BORA study investigators. Long-term safety and efficacy of benralizumab in patients with severe, uncontrolled asthma: 1-year results from the BORA phase 3 extension trial. Lancet Respir Med. 2019 Jan;7(1):46-59. doi: 10.1016/S2213-2600(18)30406-5. Epub 2018 Nov 8. Erratum In: Lancet Respir Med. 2019 Jan;7(1):e1.
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
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
- D3250C00021
- U1111-1162-2422 (Other Identifier: WHO)
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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