AsthmaPhase 3BORANCT02258542

A Safety Extension Study to Evaluate the Safety and Tolerability of Benralizumab (MEDI-563) in Asthmatic Adults and Adolescents on Inhaled Corticosteroid Plus LABA

A Phase 3 study testing Benralizumab in people with Asthma, run by AstraZeneca at 429 sites in 24 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The purpose of this study is to characterize the safety profile of benralizumab administration in asthma patients who have completed one of the three predecessor studies: D3250C00017, D3250C00018 or D3250C00020. Read more about this study

Who is it for?: Ages 12 to 75 years
Conditions the study is for: Asthma
What is being tested?: Benralizumab
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 2,133 participants
Where: 429 sitesin 24 countries
Study dates: 19 Nov 2014to 2 Jul 2018
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 12 to 75 years
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

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.

Who cannot join

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

Show all 15Show fewer

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

Trial locations and contacts

429 sites in 24 countries.

Country

City, postcode or hospital

429 sites in 24 countries

United States100 sites

Research Site
Abingdon, Virginia, 24210
Research Site
Albany, Georgia, 31707
Research Site
Albuquerque, New Mexico, 87131
Research Site
Alhambra, California, 91801
Research Site
Andalusia, Alabama, 36420
Research Site
Arlington, Texas, 76018
Research Site
Bakersfield, California, 93301
Research Site
Baltimore, Maryland, 21236
Research Site
Bangor, Maine, 04401
Research Site
Birmingham, Alabama, 35209
Research Site
Boerne, Texas, 78006
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Brandon, Florida, 33511
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Cincinnati, Ohio, 45231
Research Site
Clearwater, Florida, 33765
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Colorado Springs, Colorado, 80907
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Covington, Louisiana, 70433
Research Site
Cutler Bay, Florida, 33189
Research Site
Dallas, Texas, 75225
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Dallas, Texas, 75230
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Dallas, Texas, 75235
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Denver, Colorado, 80206
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Doral, Florida, 33172
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Durham, North Carolina, 27705
Research Site
Falls Church, Virginia, 22044
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Farmington Hills, Michigan, 48334
Research Site
Farmington Hills, Michigan, 48336
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Flint, Michigan, 48504
Research Site
Fort Mitchell, Kentucky, 41017
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Gainesville, Georgia, 30501
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Glendale, Arizona, 85306
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Greenfield, Wisconsin, 53228
Research Site
Gurnee, Illinois, 60031
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Hialeah, Florida, 33012
Research Site
Hialeah, Florida, 33013
Research Site
Hodges, South Carolina, 29653
Research Site
Homestead, Florida, 33030
Research Site
Houston, Texas, 77058
Research Site
Houston, Texas, 77081
Research Site
Houston, Texas, 77083
Research Site
Houston, Texas, 77099
Research Site
Iowa City, Iowa, 52242
Research Site
Jefferson Hills, Pennsylvania, 15025
Research Site
Lawrenceville, Georgia, 30046
Research Site
Louisville, Kentucky, 40215
Research Site
Madison, Wisconsin, 53792
Research Site
McAllen, Texas, 78504
Research Site
McKinney, Texas, 75069
Research Site
Miami, Florida, 33015
Research Site
Miami, Florida, 33126
Research Site
Miami, Florida, 33134
Research Site
Miami, Florida, 33135
Research Site
Miami, Florida, 33144
Research Site
Miami, Florida, 33176
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Middleburg Heights, Ohio, 44130
Research Site
Milwaukee, Wisconsin, 53226
Research Site
New Haven, Connecticut, 06520
Research Site
New York, New York, 10016
Research Site
Newport Beach, California, 92663
Research Site
Normal, Illinois, 61761
Research Site
Northfield, New Jersey, 08225
Research Site
Ocala, Florida, 34471-4463
Research Site
Oklahoma City, Oklahoma, 73103
Research Site
Oklahoma City, Oklahoma, 73112
Research Site
Oklahoma City, Oklahoma, 73120
Research Site
Oklahoma City, Oklahoma, 73131
Research Site
Orlando, Florida, 32819
Research Site
Orlando, Florida, 32825
Research Site
Philadelphia, Pennsylvania, 19140
Research Site
Phoenix, Arizona, 85012
Research Site
Pittsburgh, Pennsylvania, 15213
Research Site
Pittsburgh, Pennsylvania, 15241
Research Site
Provo, Utah, 84604
Research Site
Quincy, Massachusetts, 02169
Research Site
Rapid City, South Dakota, 57702
Research Site
Redondo Beach, California, 90277
Research Site
Rochester, Minnesota, 55905
Research Site
Roseville, California, 95661
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Sacramento, California, 95825
Research Site
Saint Paul, Minnesota, 55130
Research Site
Salt Lake City, Utah, 84112
Research Site
San Antonio, Texas, 78229
Research Site
San Jose, California, 95117
Research Site
Scottsboro, Alabama, 35768
Research Site
Splendora, Texas, 77372
Research Site
St Louis, Missouri, 63143
Research Site
Staten Island, New York, 10305
Research Site
Stockton, California, 95204
Research Site
Tampa, Florida, 33607
Research Site
The Bronx, New York, 10461
Research Site
Traverse City, Michigan, 49684
Research Site
Tulsa, Oklahoma, 74136
Research Site
Union, New Jersey, 07083
Research Site
Walnut Creek, California, 94598
Research Site
Warwick, Rhode Island, 02886
Research Site
Westminster, California, 92683
Research Site
Wheat Ridge, Colorado, 80033
Research Site
Wilmington, North Carolina, 28401
Research Site
Winston-Salem, North Carolina, 27104
Research Site
Winter Park, Florida, 32789
Research Site
Woodland, California, 95695

Other trials in United States

Poland52 sites

Research Site
Aleksandrów Łódzki, 95-070
Research Site
Bialystok, 15-044
Research Site
Bialystok, 15-276
Research Site
Bialystok, 15-430
Research Site
Bialystok, 15-879
Research Site
Bielsko-Biala, 43-316
Research Site
Bydgoszcz, 85-168
Research Site
Bystra, 43-360
Research Site
Dobre Miasto, 11-040
Research Site
Gdansk, 80-433
Research Site
Gdansk, 80-952
Research Site
Giżycko, 11-500
Research Site
Gorzów Wlkp, 66-400
Research Site
Grodzisk Mazowiecki, 05-825
Research Site
Karczew, 05-480
Research Site
Katowice, 40-081
Research Site
Kościan, 64-000
Research Site
Koszalin, 75-679
Research Site
Krakow, 31-011
Research Site
Krakow, 31-033
Research Site
Krakow, 31-159
Research Site
Krakow, 31-455
Research Site
Lodz, 90-141
Research Site
Lodz, 90-242
Research Site
Lodz, 91-103
Research Site
Lubin, 59-300
Research Site
Lublin, 20-089
Research Site
Lublin, 20-552
Research Site
Lublin, 20-718
Research Site
Ostrów Wielkopolski, 63-400
Research Site
Poznan, 60-214
Research Site
Poznan, 60-685
Research Site
Poznan, 60-693
Research Site
Poznan, 60-823
Research Site
Proszowice, 32-100
Research Site
Ruda Śląska, 41-709
Research Site
Rzeszów, 35-205
Research Site
Rzeszów, 35-612
Research Site
Skierniewice, 96-100
Research Site
Sosnowiec, 41-200
Research Site
Szczecin, 70-111
Research Site
Tarnów, 33-100
Research Site
Trzebnica, 55-100
Research Site
Warsaw, 01-138
Research Site
Warsaw, 01-868
Research Site
Wieluń, 98-300
Research Site
Wołomin, 05-200
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Wroclaw, 50-220
Research Site
Wroclaw, 51-162
Research Site
Wroclaw, 53-201
Research Site
Wroclaw, 53-301
Research Site
Żnin, 88-400

Other trials in Poland

Japan34 sites

Research Site
Asahi-shi, 289-2511
Research Site
Chiyoda-ku, 102-0083
Research Site
Chūōku, 103-0022
Research Site
Fukuoka, 811-1394
Research Site
Hiroshima, 732-0052
Research Site
Itabashi-ku, 173-8610
Research Site
Itabashi-ku, 174-0065
Research Site
Kagoshima, 890-0064
Research Site
Kishiwada-shi, 596-8501
Research Site
Kobe, 653-0013
Research Site
Kokubunji-shi, 185-0014
Research Site
Matsue, 690-8556
Research Site
Minatoku, 105-0003
Research Site
Mizunami-shi, 509-6134
Research Site
Niigata, 950-2085
Research Site
Obihiro-shi, 080-0013
Research Site
Ōita, 870-0021
Research Site
Ota-shi, 373-0807
Research Site
Sagamihara-shi, 252-0315
Research Site
Sakaide-shi, 762-8550
Research Site
Sakaishi, 591-8037
Research Site
Sapporo, 060-0033
Research Site
Sapporo, 064-0807
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Sendai, 983-8520
Research Site
Setagaya-ku, 158-0097
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Shibuya-ku, 150-0013
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Shinagawa-ku, 142-8666
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Sumida-ku, 130-8587
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Takamatsu, 761-7073
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Toshima-ku, 170-0003
Research Site
Tsukubo-gun, 701-0304
Research Site
Yokohama, 231-8682
Research Site
Yokohama, 234-0054
Research Site
Yokohama, 236-0024

Other trials in Japan

Russia31 sites

Research Site
Chelyabinsk, 454106
Research Site
Ivanovo, 153005
Research Site
Izhevsk, 426063
Research Site
Kazan', 420012
Research Site
Moscow, 109240
Research Site
Moscow, 115682
Research Site
Moscow, 121309
Research Site
Moscow, 123995
Research Site
Nizhny Novgorod, 603126
Research Site
Novosibirsk, 630008
Research Site
Novosibirsk, 630084
Research Site
Pyatigorsk, 357500
Research Site
Ryazan, 390026
Research Site
Saint Petersburg, 194354
Research Site
Saint Petersburg, 194356
Research Site
Saint Petersburg, 195257
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Saint Petersburg, 196084
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Saint Petersburg, 196247
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Saint Petersburg, 196657
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Saint Petersburg, 197022
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Saratov, 410053
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Smolensk, 214019
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StPetersburg, 193312
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Tomsk, 634063
Research Site
Vladikavkaz, 362007
Research Site
Vladimir, 600023
Research Site
Volgograd, 400001
Research Site
Volgograd, 400131
Research Site
Yekaterinburg, 620039
Research Site
Yekaterinburg, 620109
Research Site
Yekaterinburg, 620149

Other trials in Russia

Germany27 sites

Research Site
Aschaffenburg, 63739
Research Site
Bamberg, 96049
Research Site
Berlin, 10367
Research Site
Berlin, 10717
Research Site
Berlin, 10787
Research Site
Berlin, 12203
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Bonn, 53123
Research Site
Frankfurt, 60596
Research Site
Frankfurt am Main, 60389
Research Site
Frankfurt am Main, 60596
Research Site
Geesthacht, 21502
Research Site
Großhansdorf, 22927
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Hamburg, 22299
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Hanover, 30167
Research Site
Hanover, 30625
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Hanover, D-30173
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Herford, 32049
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Leipzig, 04103
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Leipzig, 04207
Research Site
Leipzig, 04275
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Mainz Am Rhein, 55131
Research Site
München, 80539
Research Site
München, 80639
Research Site
Neu-Isenburg, 63263
Research Site
Rostock, 18057
Research Site
Rüdersdorf, 15562
Research Site
Witten, 58452

Other trials in Germany

South Korea20 sites

Research Site
Anyang-si, 14068
Research Site
Bucheon-si, 14584
Research Site
Busan, 49201
Research Site
Busan, 602-702
Research Site
Cheongju-si, 362-804
Research Site
Gwangju, 61469
Research Site
Incheon, 21431
Research Site
Incheon, 405-760
Research Site
Jeju City, 690-767
Research Site
Seoul, 03080
Research Site
Seoul, 03312
Research Site
Seoul, 03722
Research Site
Seoul, 05030
Research Site
Seoul, 05505
Research Site
Seoul, 06591
Research Site
Seoul, 07985
Research Site
Seoul, 08308
Research Site
Seoul, 135-710
Research Site
Seoul, 150-713
Research Site
Suwon, 16499

Other trials in South Korea

Argentina19 sites

Research Site
Buenos Aires, 1121
Research Site
Buenos Aires, C1414AIF
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CABA, C1056ABJ
Research Site
CABA, C1425BEN
Research Site
CABA, C1431FWO
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Ciudad Autónoma de Bs. As., 1426
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Concepción del Uruguay, 3260
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Córdoba, X5003DCE
Research Site
Corrientes, 3400
Research Site
Florida, 1138
Research Site
Godoy Cruz
Research Site
La Plata, B1902COS
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Mar del Plata, B7600GNY
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Mendoza, 5500
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Mendoza, M5500GIP
Research Site
Nueve de Julio, B6500EZL
Research Site
Ranelagh, 1886
Research Site
Rosario, S2000DEJ
Research Site
San Miguel de Tucumán, 4000

Other trials in Argentina

United Kingdom17 sites

Research Site
Birmingham, B9 5SS
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Bradford, BD9 6RJ
Research Site
Cambridge, CB2 0QQ
Research Site
Chertsey, KT16 0PZ
Research Site
Chester, CH2 1UL
Research Site
Cottingham, HU16 5JQ
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Darlington, DL3 6HX
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Glasgow, G12 0YN
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Liverpool, L7 8XP
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Manchester, M23 9LT
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Nottingham, NG5 1PB
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Plymouth, PL6 8DH
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Portsmouth, PO6 3LY
Research Site
Soham, CB7 5JD
Research Site
Somerset, BS26 2BJ
Research Site
Stevenage, SG1 4AB
Research Site
Stockton, TS19 8PE

Other trials in United Kingdom

Bulgaria15 sites

Research Site
Dupnitsa, 2600
Research Site
Pazardzhik, 4400
Research Site
Pernik, 2300
Research Site
Petrich, 2850
Research Site
Pleven, 5800
Research Site
Rousse, 7002
Research Site
Samokov, 2000
Research Site
Sliven, 8800
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Sofia, 1002
Research Site
Sofia, 1152
Research Site
Stara Zagora, 6003
Research Site
Varna, 9000
Research Site
Velingrad, 4600
Research Site
Vratsa, 3000
Research Site
Yambol, 8600

Other trials in Bulgaria

Canada13 sites

Research Site
Burlington, Ontario, L7N 3V2
Research Site
Calgary, Alberta, T2N 4Z6
Research Site
Hamilton, Ontario, L8N 4A6
Research Site
Montreal, Quebec, H2W 1T8
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Montreal, Quebec, H4A 3J1
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Montreal, Quebec, H4J 1C5
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Ottawa, Ontario, K1G 6C6
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Québec, Quebec, G1G 3Y8
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Québec, Quebec, G1V 4G5
Research Site
Saint-Charles-Borromée, Quebec, J6E 2B4
Research Site
Sherwood Park, Alberta, T8L 0N2
Research Site
Vancouver, British Columbia, V5Z 1M9
Research Site
Vancouver, British Columbia, V6Z 1Y6

Other trials in Canada

France13 sites

Research Site
Brest, 29609
Research Site
Dijon, 21079
Research Site
Le Kremlin-Bicêtre, 94275
Research Site
Le Mans, 72037
Research Site
Lyon, 69317
Research Site
Marseille, 13015
Research Site
Montpellier, 34295
Research Site
Paris, 75018
Research Site
Pau, 64046
Research Site
Pringy, 74374
Research Site
Saint-Pierre, 97448
Research Site
Strasbourg, 67091
Research Site
Toulouse, 31059

Other trials in France

Ukraine13 sites

Research Site
Chernivtsi, 58000
Research Site
Dnipropetrovsk, 49007
Research Site
Ivano-Frankivsk, 76012
Research Site
Kharkiv, 61022
Research Site
Kharkiv, 61035
Research Site
Kharkiv, 61039
Research Site
Kharkiv, 61058
Research Site
Kharkiv, 61106
Research Site
Kyiv, 03680
Research Site
Kyiv, 04201
Research Site
Lutsk, 43000
Research Site
Uzhhorod, 88000
Research Site
Vinnytsia, 21029

Other trials in Ukraine

Australia11 sites

Research Site
Bedford Park, 5042
Research Site
Box Hill, 3128
Research Site
Clayton, 3168
Research Site
Concord, 2139
Research Site
Frankston, 3199
Research Site
Nedlands, 6009
Research Site
New Lambton Heights, 2305
Research Site
Parkville, 3050
Research Site
Prahran, 3004
Research Site
Randwick, 2031
Research Site
Woolloongabba, 4102

Other trials in Australia

Spain11 sites

Research Site
Barcelona, 08025
Research Site
Barcelona, 08036
Research Site
Lugo, 27004
Research Site
Madrid, 28040
Research Site
Málaga, 29010
Research Site
Oviedo, 33011
Research Site
Palma de Mallorca, 07010
Research Site
Sagunto(Valencia), 46520
Research Site
Salamanca, 37007
Research Site
Valencia, 46015
Research Site
Valencia, 46017

Other trials in Spain

Peru9 sites

Research Site
Cusco
Research Site
Lima, 15102
Research Site
Lima, 41
Research Site
Lima, L41
Research Site
Lima, Lima 18
Research Site
Lima, LIMA 1
Research Site
Lima, LIMA 21
Research Site
Lima, LIMA 27
Research Site
Lima, LIMA 33

Other trials in Peru

Czechia8 sites

Research Site
Jindřichův Hradec, 377 01
Research Site
Karlovy Vary, 360 17
Research Site
Ostrava, 728 80
Research Site
Pilsen, 30460
Research Site
Prague, 130 00
Research Site
Rokycany, 337 22
Research Site
Strakonice, 38601
Research Site
Teplice, 415 01

Other trials in Czechia

Brazil7 sites

Research Site
Porto Alegre, 90035074
Research Site
Porto Alegre, 90610-000
Research Site
Porto Alegre, 91350-200
Research Site
Santo André, 09080-110
Research Site
São Paulo, 04323-062
Research Site
São Paulo, 05403-000
Research Site
Sorocaba, 18040-425

Other trials in Brazil

Turkey (Türkiye)7 sites

Research Site
Adana, 01330
Research Site
Ankara, 06230
Research Site
Bursa, 16059
Research Site
Istanbul, 34098
Research Site
Istanbul, 34844
Research Site
Izmir, 35100
Research Site
Mersin, 33343

Other trials in Turkey (Türkiye)

Romania6 sites

Research Site
Bragadiru, 077025
Research Site
Bucharest, 030303
Research Site
Bucharest, 71593
Research Site
Constanța, 900002
Research Site
Deva, 330061
Research Site
Iași, 700115

Other trials in Romania

Chile5 sites

Research Site
Quillota, 2260000
Research Site
Santiago, 8207257
Research Site
Talcahuano, 4270918
Research Site
Valparaíso, 2341131
Research Site
Viña del Mar, 2520594

Other trials in Chile

South Africa4 sites

Research Site
Cape Town, 7764
Research Site
Durban, 4092
Research Site
KwaDukuza, 4450
Research Site
Mowbray, 7700

Other trials in South Africa

Philippines3 sites

Research Site
Iloilo City, 5000
Research Site
Lipa City, 4217
Research Site
Quezon City, 1101

Other trials in Philippines

Sweden2 sites

Research Site
Gothenburg
Research Site
Lund, 22185

Other trials in Sweden

Vietnam2 sites

Research Site
Hanoi, 100000
Research Site
Ho Chi Minh City, 700000

Other trials in Vietnam

About this study

Official title: 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)

Read the 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.

Conditions: Asthma
Being tested: Benralizumab
Keywords: Asthma, Bronchial Diseases, Respiratory Tract Diseases, Lung Diseases, Obstructive Lung Diseases
Medical subject headings: Asthma, Bronchial Diseases, Respiratory Tract Diseases, Lung Diseases, Lung Diseases, Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BenralizumabBiological
Benralizumab administered subcutaneously
BenralizumabBiological
Benralizumab administered subcutaneously

Study groups in NCT02258542
Study group	Role	What they receive
Benralizumab Arm A	Experimental	Benralizumab administered subcutaneously Receives: Biological: Benralizumab
Benralizumab Arm B	Experimental	Benralizumab administered subcutaneously Receives: Biological: Benralizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline in Basophils, Full Analysis Set, Excluding MELTEMI Patients
Change from baseline in hematologic lab parameter of Basophils.
Measured: Week 56
Change From Baseline in Basophils, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA)
Change from baseline in hematologic lab parameter of Basophils.
Measured: Week 108
Change From Baseline in Leukocytes, Full Analysis Set, Excluding MELTEMI Patients
Change from baseline in hematologic lab parameter of Leukocytes.
Measured: Week 56
Change From Baseline in Leukocytes, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA)
Change from baseline in hematologic lab parameter of Leukocytes.
Measured: Week 108
Change From Baseline in Lymphocytes, Full Analysis Set, Excluding MELTEMI Patients
Change from baseline in hematologic lab parameter of Lymphocytes.
Measured: Week 56
Change From Baseline in Lymphocytes, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA)
Change from baseline in hematologic lab parameter of Lymphocytes.
Measured: Week 108
Change From Baseline in Neutrophils, Full Analysis Set, Excluding MELTEMI Patients
Change from baseline in hematologic lab parameter of Neutrophils.
Measured: Week 56
Change From Baseline in Neutrophils, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA)
Change from baseline in hematologic lab parameter of Neutrophils.
Measured: Week 108
Change From Baseline in Eosinophils, Full Analysis Set, Excluding MELTEMI Patients
Change from baseline in hematologic lab parameter of Eosinophils.
Measured: Week 56
Change From Baseline in Eosinophils, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA)
Change from baseline in hematologic lab parameter of Eosinophils.
Measured: Week 108
Change From Baseline in Alanine Aminotransferase (ALT), Full Analysis Set, Excluding MELTEMI Patients
Change from baseline in chemistry tests ALT.
Measured: Week 56
Change From Baseline in ALT, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA)
Change from baseline in hematologic lab parameter of ALT.
Measured: Week 108
Change From Baseline in Aspartate Aminotransferase (AST), Full Analysis Set, Excluding MELTEMI Patients
Change from baseline in chemistry tests AST.
Measured: Week 56
Change From Baseline in AST, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA)
Change from baseline in hematologic lab parameter of AST.
Measured: Week 108
Change From Baseline in Bilirubin, Full Analysis Set, Excluding MELTEMI Patients
Change from baseline in chemistry test Bilirubin.
Measured: Week 56
Change From Baseline in Bilirubin, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA)
Change from baseline in hematologic lab parameter of Bilirubin.
Measured: Week 108

Secondary outcomes (26)

Number of Overall Patients With Asthma Exacerbations During Study Period
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
Measured: 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)
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
Measured: 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)
Change from baseline to Week 56 in Pre-bronchodilator Forced expiratory volume in 1 second (FEV1).
Measured: Week 56
Change From Baseline in Pre-bronchodilator FEV1 (L), Adolescents Only (SIROCCO/CALIMA)
Change from baseline to Week 108 in Pre-bronchodilator Forced expiratory volume in 1 second (FEV1).
Measured: Week 108
Change From Baseline in Post-bronchodilator FEV1 (L)
Change from baseline to Week 56 in Post-bronchodilator Forced expiratory volume in 1 second (FEV1).
Measured: Week 56
Change From Baseline in Post-bronchodilator FEV1 (L), Adolescents Only (SIROCCO/CALIMA)
Change from baseline to Week 108 in Post-bronchodilator Forced expiratory volume in 1 second (FEV1).
Measured: Week 108
Change From Baseline in Asthma Control Questionnaire (ACQ) as a Measure of Asthma Control in Overall Patients
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.
Measured: Week 56
Change From Baseline in Asthma Control Questionnaire (ACQ) as a Measure of Asthma Control in Overall Patients, Adolescents Only (SIROCCO/CALIMA)
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.
Measured: Week 108
Change From Baseline in Total Score of Asthma Related and General Health-related Quality of Life Questionnaire (AQLQ(S)+12)
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.
Measured: 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)
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.
Measured: Week 108
Change of Blood Eosinophil Levels' Measurement in Overall Patients
Change from baseline to Week 56 in Blood eosinophils
Measured: Week 56
Change of Blood Eosinophil Levels' Measurement in Adolescents Patients (SIROCCO/CALIMA).
Change from baseline to Week 108 in Blood eosinophils.
Measured: Week 108
Change From Baseline in EQ-5D-5L Visual Analog Scale
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.
Measured: Week 56
Change From Baseline in EQ-5D-5L Visual Analog Scale, Adolescents Only (SIROCCO/CALIMA)
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.
Measured: Week 108
Work Productivity Loss in Adults, Using Work Productivity and Activity Impairment Questionnaire (WPAI)
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.
Measured: Week 68
Work Productivity Loss in Adults, Using Work Productivity and Activity Impairment Questionnaire (WPAI), Adolescents Only (SIROCCO/CALIMA)
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.
Measured: Week 108
Classroom Productivity Loss Using Classroom Impairment Questionnaire (CIQ)
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.
Measured: Week 56
Classroom Productivity Loss Using Classroom Impairment Questionnaire (CIQ), Adolescents Only (SIROCCO/CALIMA)
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.
Measured: Week 108
Activity Impairment (%), Using Work Productivity and Activity Impairment Questionnaire (WPAI)
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.
Measured: Week 68
Activity Impairment (%), Using Work Productivity and Activity Impairment Questionnaire (WPAI), Adolescents Only (SIROCCO/CALIMA)
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.
Measured: 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
Hospitalizations, Emergency department (ED) visits, urgent care visits and all other outpatient visits due to asthma
Measured: 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)
Hospitalizations, ED visits, urgent care visits and all other outpatient visits due to asthma
Measured: Baseline and Week 108
Pre-dose Benralizumab Concentration in Serum During the Treatment Phase of the Safety Study
Endpoint: Pharmacokinetic (PK) parameters
Measured: Week 0 and Week 56
Pre-dose Benralizumab Concentration in Serum During the Treatment Phase of the Safety Study, Adolescents Only (SIROCCO/CALIMA)
Endpoint: Pharmacokinetic (PK) parameters
Measured: Baseline and Week 108
Number of Patients With Anti-drug Antibodies (ADA) Responses During the Study
Assessments for the presence of ADA and neutralizing antibody (nAb) throughout study
Measured: 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)
Assessments for the presence of ADA and nAb throughout study
Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

19 Nov 20142 Jul 2018

First posted7 Oct 2014 (estimated)
Study start19 Nov 2014
Primary completion18 Oct 2017
Study completion2 Jul 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for AsthmaStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 2,133 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02258542
Sponsor's protocol ID: D3250C00021
Other IDs: U1111-1162-2422
Acronym: BORA
Status last verified: Jul 2019
First submitted: 1 Sep 2014
Last updated: 21 Aug 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

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.
PubMed 33609624
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.
PubMed 30416083

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 21 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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)
ClinicalTrials.gov ID: NCT02258542
Acronym / sponsor ID: BORA / D3250C00021
Conditions: Asthma
Keywords: Asthma, Bronchial Diseases, Respiratory Tract Diseases, Lung Diseases, Obstructive Lung Diseases
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 2,133 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: 19 Nov 2014 (actual)
Primary completion: 18 Oct 2017 (actual)
Study completion: 2 Jul 2018 (actual)
First posted: 7 Oct 2014 (estimated)
Results: Posted 6 Feb 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Benralizumab Arm A	Experimental	Biological: BenralizumabBenralizumab administered subcutaneously
Benralizumab Arm B	Experimental	Biological: BenralizumabBenralizumab administered subcutaneously

Who may qualify

Ages: 12 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (15 listed)

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:
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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
BenralizumabBenralizumab administered subcutaneously	Biological	Benralizumab Arm A
BenralizumabBenralizumab administered subcutaneously	Biological	Benralizumab Arm B

Primary outcome

Change From Baseline in Basophils, Full Analysis Set, Excluding MELTEMI Patients
Time frame: Week 56
Change from baseline in hematologic lab parameter of Basophils.
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.
Change From Baseline in Leukocytes, Full Analysis Set, Excluding MELTEMI Patients
Time frame: Week 56
Change from baseline in hematologic lab parameter of Leukocytes.
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.
Change From Baseline in Lymphocytes, Full Analysis Set, Excluding MELTEMI Patients
Time frame: Week 56
Change from baseline in hematologic lab parameter of Lymphocytes.
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.
Change From Baseline in Neutrophils, Full Analysis Set, Excluding MELTEMI Patients
Time frame: Week 56
Change from baseline in hematologic lab parameter of Neutrophils.
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.
Change From Baseline in Eosinophils, Full Analysis Set, Excluding MELTEMI Patients
Time frame: Week 56
Change from baseline in hematologic lab parameter of Eosinophils.
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.
Change From Baseline in Alanine Aminotransferase (ALT), Full Analysis Set, Excluding MELTEMI Patients
Time frame: Week 56
Change from baseline in chemistry tests ALT.
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.
Change From Baseline in Aspartate Aminotransferase (AST), Full Analysis Set, Excluding MELTEMI Patients
Time frame: Week 56
Change from baseline in chemistry tests AST.
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.
Change From Baseline in Bilirubin, Full Analysis Set, Excluding MELTEMI Patients
Time frame: Week 56
Change from baseline in chemistry test Bilirubin.
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.

26 secondary outcomes

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)
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)
Change From Baseline in Pre-bronchodilator FEV1 (L)
Time frame: Week 56
Change From Baseline in Pre-bronchodilator FEV1 (L), Adolescents Only (SIROCCO/CALIMA)
Time frame: Week 108
Change From Baseline in Post-bronchodilator FEV1 (L)
Time frame: Week 56
Change From Baseline in Post-bronchodilator FEV1 (L), Adolescents Only (SIROCCO/CALIMA)
Time frame: Week 108
Change From Baseline in Asthma Control Questionnaire (ACQ) as a Measure of Asthma Control in Overall Patients
Time frame: 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
Change From Baseline in Total Score of Asthma Related and General Health-related Quality of Life Questionnaire (AQLQ(S)+12)
Time frame: 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
Change of Blood Eosinophil Levels' Measurement in Overall Patients
Time frame: Week 56
Change of Blood Eosinophil Levels' Measurement in Adolescents Patients (SIROCCO/CALIMA).
Time frame: Week 108
Change From Baseline in EQ-5D-5L Visual Analog Scale
Time frame: Week 56
Change From Baseline in EQ-5D-5L Visual Analog Scale, Adolescents Only (SIROCCO/CALIMA)
Time frame: Week 108
Work Productivity Loss in Adults, Using Work Productivity and Activity Impairment Questionnaire (WPAI)
Time frame: Week 68
Work Productivity Loss in Adults, Using Work Productivity and Activity Impairment Questionnaire (WPAI), Adolescents Only (SIROCCO/CALIMA)
Time frame: Week 108
Classroom Productivity Loss Using Classroom Impairment Questionnaire (CIQ)
Time frame: Week 56
Classroom Productivity Loss Using Classroom Impairment Questionnaire (CIQ), Adolescents Only (SIROCCO/CALIMA)
Time frame: Week 108
Activity Impairment (%), Using Work Productivity and Activity Impairment Questionnaire (WPAI)
Time frame: Week 68
Activity Impairment (%), Using Work Productivity and Activity Impairment Questionnaire (WPAI), Adolescents Only (SIROCCO/CALIMA)
Time frame: 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)
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
Pre-dose Benralizumab Concentration in Serum During the Treatment Phase of the Safety Study
Time frame: 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
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
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

Results and safety

Results posted to the registry on 6 Feb 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks	953	911
SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks	973	924
ZONDA - Benralizumab 30 mg q.4 Weeks	100	92
ZONDA - Benralizumab 30 mg q.8 Weeks	97	92

Primary outcome: Change From Baseline in Basophils, Full Analysis Set, Excluding MELTEMI Patients

Time frame: Week 56. Mean (Standard Deviation). Unit: 10^9 cells/L

Measure	SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks n = 691	SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks n = 703	ZONDA - Benralizumab 30 mg q.4 Weeks n = 39	ZONDA - Benralizumab 30 mg q.8 Weeks n = 42
Value	-0.005 (0.0223)	-0.005 (0.0239)	-0.007 (0.0283)	-0.005 (0.0244)

Population analysed: Full analysis set, excluding MELTEMI patients. For each lab tests, number of patients is the number of patients with available change from baseline value.

Primary outcome: Change From Baseline in Basophils, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA)

Time frame: Week 108. Mean (Standard Deviation). Unit: 10^9 cells/L

Measure	SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks n = 16	SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks n = 45
Value	-0.006 (0.0145)	0.001 (0.0208)

Population analysed: Full analysis set, adolescents only (studies SIROCCO/CALIMA only, study ZONDA does not enroll adolescents). For each lab tests, number of patients is the number of patients with available change from baseline value.

Primary outcome: Change From Baseline in Leukocytes, Full Analysis Set, Excluding MELTEMI Patients

Time frame: Week 56. Mean (Standard Deviation). Unit: 10^9 cells/L

Measure	SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks n = 695	SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks n = 710	ZONDA - Benralizumab 30 mg q.4 Weeks n = 39	ZONDA - Benralizumab 30 mg q.8 Weeks n = 42
Value	-0.344 (2.0412)	-0.128 (1.8614)	-0.808 (1.8177)	-0.507 (3.3612)

Population analysed: Full analysis set, excluding MELTEMI patients. For each lab tests, number of patients is the number of patients with available change from baseline value.

Primary outcome: Change From Baseline in Leukocytes, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA)

Time frame: Week 108. Mean (Standard Deviation). Unit: 10^9 cells/L

Measure	SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks n = 16	SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks n = 47
Value	-0.487 (1.7289)	-0.079 (1.8432)

26 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adults completed 56 weeks of treatment period and 12 weeks follow-up period; and adolescents completed 108 weeks of treatment period and 12 weeks follow-up period.. Other adverse events reported at 3% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks	102 of 783 (13%)	415 of 783 (53%)	5 of 783
SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks	94 of 793 (11.9%)	409 of 793 (51.6%)	4 of 793
ZONDA - Benralizumab 30 mg q.4 Weeks	10 of 49 (20.4%)	33 of 49 (67.3%)	0 of 49
ZONDA - Benralizumab 30 mg q.8 Weeks	9 of 49 (18.4%)	38 of 49 (77.6%)	1 of 49

Limitations and caveats (from the sponsor): Patients in this study had to complete treatment in predecessor studies. Therefore selection bias may exist. Baseline is defined for this study's entry value, not all values are prior to active treatment due to some patients being treated previously.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 33609624Busse 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.
Derived from this study: PubMed 30416083Busse 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.
Related InfoLink provided by the sponsor.
Related InfoLink provided by the sponsor.
BORA clinical study protocol-redactedLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

William W. Busse, M.D., Professor of Medicine principal investigator

Allergy, Pulmonary, and Critical Care Medicine 600 Highland Avenue; Madison, WI

429 sites in 24 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Benralizumab in people with Asthma, run by AstraZeneca at 429 sites in 24 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 429 sites in United States, Poland, Japan, Russia, Germany and 19 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Basophils, Full Analysis Set, Excluding MELTEMI Patients (time frame: Week 56). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02258542, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2019.