Phase
Condition
Asthma
Lung Disease
Treatment
Benralizumab
Placebo
Clinical Study ID
Ages 18-70 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Male or female aged 18 through 70 years.
Physician-diagnosed asthma requiring continuous treatment with medium- or high-doseICS plus LABA with or without additional controller medication for at least 12months prior to Visit 1, and current treatment with high-dose ICS plus LABA for atleast 3 months prior to Visit 1 with or without additional asthma maintenancemedication.
Morning pre-BD FEV1 ≥50 to <80% of predicted normal value (PNV) and ≥1 liter (L) ormorning pre-BD FEV1 ≥ 50 to < 90% of PNV, if historical pre-BD FEV1 value (within 12months prior to screening visit) was < 80% of PNV.
A blood eosinophil count meeting any of 3 criteria: ≥300 cells/µL during screeningor ≥ 220 to < 300 cells/μL during screening and documented eosinophil count of ≥ 300cells/μL in the past 12 months, or ≥150 to <300 cells/µL during screening plus oneof the following: presence of nasal polyps or pre-BD FVC <65% predicted at Visit 2
Negative pregnancy test.
Asthma control questionnaire (ACQ-6) >1.5.
Fewer than 12 exacerbations within the 6 months prior to Visit 3.
Exclusion
Exclusion Criteria:
- Any disease or concomitant medication which could affect study results or safety ofstudy participants, including:
current smokers
history of cancer
life-threatening asthma
clinically important pulmonary disease other than asthma
Use of chronic immunosuppressive medication or receipt of immunoglobulin (or bloodproducts) within 30 days prior to the date informed consent is obtained.
Previously received:
benralizumab
live attenuated vaccines 30 days prior to the date of randomization.
bronchial thermoplasty in the last 24 months prior to Visit 1
any investigational non-biologic within 30 days (or 5 half-lives) prior to thedate informed consent is obtained, whichever is longer.
any marketed or investigational biologic for the treatment of asthma within 4months (or 5 half-lives) prior to the date informed consent is obtained,whichever is longer.
- Currently pregnant, breastfeeding or lactating women.
Study Design
Connect with a study center
Research Site
Calgary, Alberta T2N 4Z6
CanadaSite Not Available
Research Site
Edmonton, Alberta T6G 2G3
CanadaSite Not Available
Research Site
Calgary 5913490, Alberta 5883102 T2N 4Z6
CanadaSite Not Available
Research Site
Hamilton, Ontario L8N 4A6
CanadaSite Not Available
Research Site
Aalborg 2624886, 9000
DenmarkSite Not Available
Research Site
Aarhus N, 8200
DenmarkSite Not Available
Research Site
Aarhus N 11746890, 8200
DenmarkSite Not Available
Research Site
Copenhagen 2618425, 2400
DenmarkSite Not Available
Research Site
Hvidovre, 2650
DenmarkSite Not Available
Research Site
Hvidovre 2619528, 2650
DenmarkSite Not Available
Research Site
København, 2400
DenmarkSite Not Available
Research Site
København NV, 2400
DenmarkSite Not Available
Research Site
Naestved, 4700
DenmarkSite Not Available
Research Site
Næstved 2616038, 4700
DenmarkSite Not Available
Research Site
Odense C, 5000
DenmarkSite Not Available
Research Site
Odense C 11746507, 5000
DenmarkSite Not Available
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Vejle, 7100
DenmarkSite Not Available
Research Site
Vejle 2610613, 7100
DenmarkSite Not Available
Research Site
Ålborg, 9000
DenmarkSite Not Available
Research Site
Gothenburg 2711537, 413 45
SwedenSite Not Available
Research Site
Göteborg, 413 45
SwedenSite Not Available
Research Site
Lund, 221 85
SwedenSite Not Available
Research Site
Lund 2693678, 22185
SwedenSite Not Available
Research Site
Cambridge, CB2 2QQ
United KingdomSite Not Available
Research Site
Cambridge 2653941, CB2 2QQ
United KingdomSite Not Available
Research Site
Headington, OX3 9DU
United KingdomSite Not Available
Research Site
Headington 2647239, OX3 9DU
United KingdomSite Not Available
Research Site
Leicester, LE3 9QP
United KingdomSite Not Available
Research Site
Leicester 2644668, LE3 9QP
United KingdomSite Not Available
Research Site
Liverpool, L7 8XP
United KingdomSite Not Available
Research Site
Liverpool 2644210, L7 8XP
United KingdomSite Not Available
Research Site
London, SW3 6HP
United KingdomSite Not Available
Research Site
London 2643743, W1G 8HU
United KingdomSite Not Available
Research Site
Oxford, OX3 7LE
United KingdomSite Not Available
Research Site
Wythenshawe, M23 9LT
United KingdomSite Not Available
Research Site
Wythenshawe 2633432, M23 9LT
United KingdomSite Not Available
Research Site
Birmingham, Alabama 35209
United StatesSite Not Available
Research Site
Birmingham 4049979, Alabama 4829764 35209
United StatesSite Not Available
Research Site
Los Angeles, California 90048
United StatesSite Not Available
Research Site
Los Angeles 5368361, California 5332921 90033
United StatesSite Not Available
Research Site
Aurora, Colorado 80045
United StatesSite Not Available
Research Site
New Haven, Connecticut 06510
United StatesSite Not Available
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Jacksonville, Florida 32216
United StatesSite Not Available
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Miami, Florida 33166
United StatesSite Not Available
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Saint Cloud, Florida 34769
United StatesSite Not Available
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Jacksonville 4160021, Florida 4155751 32204
United StatesSite Not Available
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Miami 4164138, Florida 4155751 33166
United StatesSite Not Available
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Decatur, Georgia 30033
United StatesSite Not Available
Research Site
Snellville, Georgia 30078
United StatesSite Not Available
Research Site
Snellville 4223413, Georgia 4197000 30078
United StatesSite Not Available
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Indianapolis, Indiana 46268
United StatesSite Not Available
Research Site
Indianapolis 4259418, Indiana 4921868 46268
United StatesSite Not Available
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Iowa City, Iowa 52242
United StatesSite Not Available
Research Site
Iowa City 4862034, Iowa 4862182 52242
United StatesSite Not Available
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Hutchinson, Kansas 67502
United StatesSite Not Available
Research Site
Kansas City, Kansas 66160
United StatesSite Not Available
Research Site
Kansas City 4273837, Kansas 4273857 66160
United StatesSite Not Available
Research Site
Baltimore, Maryland 21224
United StatesSite Not Available
Research Site
Boston, Massachusetts 02115
United StatesSite Not Available
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Ann Arbor, Michigan 48109
United StatesSite Not Available
Research Site
Bloomfield Hills, Michigan 48301
United StatesSite Not Available
Research Site
Ann Arbor 4984247, Michigan 5001836 48109
United StatesSite Not Available
Research Site
Bloomfield Hills 4986429, Michigan 5001836 48301
United StatesSite Not Available
Research Site
Rochester, Minnesota 55905
United StatesSite Not Available
Research Site
Rochester 5043473, Minnesota 5037779 55905
United StatesSite Not Available
Research Site
Saint Louis, Missouri 63156
United StatesSite Not Available
Research Site
St Louis 4407066, Missouri 4398678 63156
United StatesSite Not Available
Research Site
Maspeth, New York 11378
United StatesSite Not Available
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Port Jefferson Station, New York 11776
United StatesSite Not Available
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Maspeth 5126180, New York 5128638 11378
United StatesSite Not Available
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Durham, North Carolina 27705
United StatesSite Not Available
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Greenville, North Carolina 27834
United StatesSite Not Available
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New Bern, North Carolina 28562
United StatesSite Not Available
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Winston-Salem, North Carolina 27104
United StatesSite Not Available
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New Bern 4481682, North Carolina 4482348 28562
United StatesSite Not Available
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Winston-Salem 4499612, North Carolina 4482348 27104
United StatesSite Not Available
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Philadelphia, Pennsylvania 19107
United StatesSite Not Available
Research Site
Pittsburgh, Pennsylvania 15213
United StatesSite Not Available
Research Site
Sayre, Pennsylvania 18840
United StatesSite Not Available
Research Site
Pittsburgh 5206379, Pennsylvania 6254927 15213
United StatesSite Not Available
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Charleston, South Carolina 29414
United StatesSite Not Available
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Spartanburg, South Carolina 29303
United StatesSite Not Available
Research Site
Galveston, Texas 77555
United StatesSite Not Available
Research Site
Lewisville, Texas 75067
United StatesSite Not Available
Research Site
Mansfield, Texas 76063
United StatesSite Not Available
Research Site
McAllen, Texas 78503
United StatesSite Not Available
Research Site
McKinney, Texas 75069
United StatesSite Not Available
Research Site
Galveston 4692883, Texas 4736286 77555
United StatesSite Not Available
Research Site
Lewisville 4706057, Texas 4736286 75067
United StatesSite Not Available
Research Site
Mansfield 4709013, Texas 4736286 76063
United StatesSite Not Available
Research Site
Williamsburg, Virginia 23188
United StatesSite Not Available

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