Benralizumab Airway Remodeling Study in Severe Eosinophilic Asthmatics

Last updated: February 10, 2026
Sponsor: AstraZeneca
Overall Status: Active - Not Recruiting

Phase

4

Condition

Asthma

Lung Disease

Treatment

Benralizumab

Placebo

Clinical Study ID

NCT03953300
D3250C00059
2018-003391-13
  • Ages 18-70
  • All Genders

Study Summary

The purpose of the study is to evaluate effect of benralizumab on structural and lung function changes in severe eosinophilic asthmatics.

Changes will be assessed over 48 week treatment period in patients with persistent symptoms despite standard therapy of inhaled corticosteroids (ICS) plus long acting B2-agonist (LABA) with or without additional controller medication.

Patients who complete treatment will enter 4 weeks follow-up period.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Male or female aged 18 through 70 years.

  2. 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.

  3. 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.

  4. 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

  5. Negative pregnancy test.

  6. Asthma control questionnaire (ACQ-6) >1.5.

  7. Fewer than 12 exacerbations within the 6 months prior to Visit 3.

Exclusion

Exclusion Criteria:

  1. 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

  1. Use of chronic immunosuppressive medication or receipt of immunoglobulin (or bloodproducts) within 30 days prior to the date informed consent is obtained.

  2. 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.

  1. Currently pregnant, breastfeeding or lactating women.

Study Design

Total Participants: 75
Treatment Group(s): 2
Primary Treatment: Benralizumab
Phase: 4
Study Start date:
October 08, 2019
Estimated Completion Date:
October 19, 2026

Connect with a study center

  • Research Site

    Calgary, Alberta T2N 4Z6
    Canada

    Site Not Available

  • Research Site

    Edmonton, Alberta T6G 2G3
    Canada

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  • Research Site

    Calgary 5913490, Alberta 5883102 T2N 4Z6
    Canada

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    Hamilton, Ontario L8N 4A6
    Canada

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  • Research Site

    Aalborg 2624886, 9000
    Denmark

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    Aarhus N, 8200
    Denmark

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    Aarhus N 11746890, 8200
    Denmark

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    Copenhagen 2618425, 2400
    Denmark

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  • Research Site

    Hvidovre, 2650
    Denmark

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    Hvidovre 2619528, 2650
    Denmark

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    København, 2400
    Denmark

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    København NV, 2400
    Denmark

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    Naestved, 4700
    Denmark

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    Næstved 2616038, 4700
    Denmark

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    Odense C, 5000
    Denmark

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  • Research Site

    Odense C 11746507, 5000
    Denmark

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  • Research Site

    Vejle, 7100
    Denmark

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    Vejle 2610613, 7100
    Denmark

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    Ålborg, 9000
    Denmark

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    Gothenburg 2711537, 413 45
    Sweden

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    Göteborg, 413 45
    Sweden

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    Lund, 221 85
    Sweden

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  • Research Site

    Lund 2693678, 22185
    Sweden

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    Cambridge, CB2 2QQ
    United Kingdom

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    Cambridge 2653941, CB2 2QQ
    United Kingdom

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    Headington, OX3 9DU
    United Kingdom

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    Headington 2647239, OX3 9DU
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    Leicester, LE3 9QP
    United Kingdom

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    Leicester 2644668, LE3 9QP
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    Liverpool, L7 8XP
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    Liverpool 2644210, L7 8XP
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    London, SW3 6HP
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    London 2643743, W1G 8HU
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    Oxford, OX3 7LE
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    Wythenshawe, M23 9LT
    United Kingdom

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    Wythenshawe 2633432, M23 9LT
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    Birmingham, Alabama 35209
    United States

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    Birmingham 4049979, Alabama 4829764 35209
    United States

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    Los Angeles, California 90048
    United States

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    Los Angeles 5368361, California 5332921 90033
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    Aurora, Colorado 80045
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    New Haven, Connecticut 06510
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    Jacksonville, Florida 32216
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    Miami, Florida 33166
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    Saint Cloud, Florida 34769
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    Jacksonville 4160021, Florida 4155751 32204
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    Miami 4164138, Florida 4155751 33166
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    Decatur, Georgia 30033
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    Snellville, Georgia 30078
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    Snellville 4223413, Georgia 4197000 30078
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    Indianapolis, Indiana 46268
    United States

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    Indianapolis 4259418, Indiana 4921868 46268
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    Iowa City, Iowa 52242
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    Iowa City 4862034, Iowa 4862182 52242
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    Hutchinson, Kansas 67502
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    Kansas City, Kansas 66160
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    Kansas City 4273837, Kansas 4273857 66160
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    Baltimore, Maryland 21224
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    Boston, Massachusetts 02115
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    Ann Arbor, Michigan 48109
    United States

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    Bloomfield Hills, Michigan 48301
    United States

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    Ann Arbor 4984247, Michigan 5001836 48109
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    Bloomfield Hills 4986429, Michigan 5001836 48301
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    Rochester, Minnesota 55905
    United States

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    Rochester 5043473, Minnesota 5037779 55905
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  • Research Site

    Saint Louis, Missouri 63156
    United States

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  • Research Site

    St Louis 4407066, Missouri 4398678 63156
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  • Research Site

    Maspeth, New York 11378
    United States

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  • Research Site

    Port Jefferson Station, New York 11776
    United States

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    Maspeth 5126180, New York 5128638 11378
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    Durham, North Carolina 27705
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    Greenville, North Carolina 27834
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    New Bern, North Carolina 28562
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    Winston-Salem, North Carolina 27104
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    New Bern 4481682, North Carolina 4482348 28562
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    Winston-Salem 4499612, North Carolina 4482348 27104
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    Philadelphia, Pennsylvania 19107
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    Pittsburgh, Pennsylvania 15213
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    Sayre, Pennsylvania 18840
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    Pittsburgh 5206379, Pennsylvania 6254927 15213
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    Charleston, South Carolina 29414
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    Spartanburg, South Carolina 29303
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    Galveston, Texas 77555
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    Lewisville, Texas 75067
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    Mansfield, Texas 76063
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  • Research Site

    McAllen, Texas 78503
    United States

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  • Research Site

    McKinney, Texas 75069
    United States

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  • Research Site

    Galveston 4692883, Texas 4736286 77555
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  • Research Site

    Lewisville 4706057, Texas 4736286 75067
    United States

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  • Research Site

    Mansfield 4709013, Texas 4736286 76063
    United States

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  • Research Site

    Williamsburg, Virginia 23188
    United States

    Site Not Available

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