Phase
Condition
Asthma
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
CanadaActive - Recruiting
Research Site
Edmonton, Alberta T6G 2G3
CanadaSite Not Available
Research Site
Hamilton, Ontario L8N 4A6
CanadaSite Not Available
Research Site
Aarhus N, 8200
DenmarkCompleted
Research Site
Hvidovre, 2650
DenmarkSite Not Available
Research Site
København, 2400
DenmarkActive - Recruiting
Research Site
København NV, 2400
DenmarkSite Not Available
Research Site
Naestved, 4700
DenmarkActive - Recruiting
Research Site
Odense C, 5000
DenmarkCompleted
Research Site
Vejle, 7100
DenmarkCompleted
Research Site
Ålborg, 9000
DenmarkActive - Recruiting
Research Site
Göteborg, 413 45
SwedenActive - Recruiting
Research Site
Lund, 221 85
SwedenCompleted
Research Site
Cambridge, CB2 2QQ
United KingdomActive - Recruiting
Research Site
Headington, OX3 9DU
United KingdomCompleted
Research Site
Leicester, LE3 9QP
United KingdomActive - Recruiting
Research Site
Liverpool, L7 8XP
United KingdomActive - Recruiting
Research Site
London, W1G 8HU
United KingdomActive - Recruiting
Research Site
Oxford, OX3 7LE
United KingdomSite Not Available
Research Site
Wythenshawe, M23 9LT
United KingdomCompleted
Research Site
Birmingham, Alabama 35209
United StatesActive - Recruiting
Research Site
Los Angeles, California 90033
United StatesActive - Recruiting
Research Site
Aurora, Colorado 80045
United StatesSite Not Available
Research Site
New Haven, Connecticut 06510
United StatesSite Not Available
Research Site
Jacksonville, Florida 32204
United StatesActive - Recruiting
Research Site
Miami, Florida 33166
United StatesActive - Recruiting
Research Site
Saint Cloud, Florida 34769
United StatesSite Not Available
Research Site
Decatur, Georgia 30033
United StatesSite Not Available
Research Site
Snellville, Georgia 30078
United StatesActive - Recruiting
Research Site
Indianapolis, Indiana 46268
United StatesActive - Recruiting
Research Site
Iowa City, Iowa 52242
United StatesSite Not Available
Research Site
Hutchinson, Kansas 67502
United StatesSite Not Available
Research Site
Kansas City, Kansas 66160
United StatesActive - Recruiting
Research Site
Baltimore, Maryland 21224
United StatesSite Not Available
Research Site
Boston, Massachusetts 02115
United StatesSite Not Available
Research Site
Ann Arbor, Michigan 48109
United StatesActive - Recruiting
Research Site
Bloomfield Hills, Michigan 48301
United StatesActive - Recruiting
Research Site
Rochester, Minnesota 55905
United StatesActive - Recruiting
Research Site
Saint Louis, Missouri 63156
United StatesActive - Recruiting
Research Site
Maspeth, New York 11378
United StatesActive - Recruiting
Research Site
Port Jefferson Station, New York 11776
United StatesSite Not Available
Research Site
Durham, North Carolina 27705
United StatesSite Not Available
Research Site
Greenville, North Carolina 27834
United StatesSite Not Available
Research Site
New Bern, North Carolina 28562
United StatesTerminated
Research Site
Winston-Salem, North Carolina 27104
United StatesSite Not Available
Research Site
Philadelphia, Pennsylvania 19140
United StatesSite Not Available
Research Site
Pittsburgh, Pennsylvania 15213
United StatesSite Not Available
Research Site
Sayre, Pennsylvania 18840
United StatesSite Not Available
Research Site
Charleston, South Carolina 29414
United StatesSite Not Available
Research Site
Spartanburg, South Carolina 29303
United StatesSite Not Available
Research Site
Galveston, Texas 77555
United StatesActive - Recruiting
Research Site
Lewisville, Texas 75067
United StatesActive - Recruiting
Research Site
Mansfield, Texas 76063
United StatesActive - Recruiting
Research Site
McAllen, Texas 78503
United StatesSite Not Available
Research Site
McKinney, Texas 75069
United StatesSite Not Available
Research Site
Williamsburg, Virginia 23188
United StatesSite Not Available
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