Benralizumab Airway Remodeling Study in Severe Eosinophilic Asthmatics

Last updated: April 9, 2025
Sponsor: AstraZeneca
Overall Status: Active - Recruiting

Phase

4

Condition

Asthma

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: 81
Treatment Group(s): 2
Primary Treatment: Benralizumab
Phase: 4
Study Start date:
October 17, 2019
Estimated Completion Date:
September 09, 2026

Connect with a study center

  • Research Site

    Calgary, Alberta T2N 4Z6
    Canada

    Active - Recruiting

  • Research Site

    Edmonton, Alberta T6G 2G3
    Canada

    Site Not Available

  • Research Site

    Hamilton, Ontario L8N 4A6
    Canada

    Site Not Available

  • Research Site

    Aarhus N, 8200
    Denmark

    Completed

  • Research Site

    Hvidovre, 2650
    Denmark

    Site Not Available

  • Research Site

    København, 2400
    Denmark

    Active - Recruiting

  • Research Site

    København NV, 2400
    Denmark

    Site Not Available

  • Research Site

    Naestved, 4700
    Denmark

    Active - Recruiting

  • Research Site

    Odense C, 5000
    Denmark

    Completed

  • Research Site

    Vejle, 7100
    Denmark

    Completed

  • Research Site

    Ålborg, 9000
    Denmark

    Active - Recruiting

  • Research Site

    Göteborg, 413 45
    Sweden

    Active - Recruiting

  • Research Site

    Lund, 221 85
    Sweden

    Completed

  • Research Site

    Cambridge, CB2 2QQ
    United Kingdom

    Active - Recruiting

  • Research Site

    Headington, OX3 9DU
    United Kingdom

    Completed

  • Research Site

    Leicester, LE3 9QP
    United Kingdom

    Active - Recruiting

  • Research Site

    Liverpool, L7 8XP
    United Kingdom

    Active - Recruiting

  • Research Site

    London, W1G 8HU
    United Kingdom

    Active - Recruiting

  • Research Site

    Oxford, OX3 7LE
    United Kingdom

    Site Not Available

  • Research Site

    Wythenshawe, M23 9LT
    United Kingdom

    Completed

  • Research Site

    Birmingham, Alabama 35209
    United States

    Active - Recruiting

  • Research Site

    Los Angeles, California 90033
    United States

    Active - Recruiting

  • Research Site

    Aurora, Colorado 80045
    United States

    Site Not Available

  • Research Site

    New Haven, Connecticut 06510
    United States

    Site Not Available

  • Research Site

    Jacksonville, Florida 32204
    United States

    Active - Recruiting

  • Research Site

    Miami, Florida 33166
    United States

    Active - Recruiting

  • Research Site

    Saint Cloud, Florida 34769
    United States

    Site Not Available

  • Research Site

    Decatur, Georgia 30033
    United States

    Site Not Available

  • Research Site

    Snellville, Georgia 30078
    United States

    Active - Recruiting

  • Research Site

    Indianapolis, Indiana 46268
    United States

    Active - Recruiting

  • Research Site

    Iowa City, Iowa 52242
    United States

    Site Not Available

  • Research Site

    Hutchinson, Kansas 67502
    United States

    Site Not Available

  • Research Site

    Kansas City, Kansas 66160
    United States

    Active - Recruiting

  • Research Site

    Baltimore, Maryland 21224
    United States

    Site Not Available

  • Research Site

    Boston, Massachusetts 02115
    United States

    Site Not Available

  • Research Site

    Ann Arbor, Michigan 48109
    United States

    Active - Recruiting

  • Research Site

    Bloomfield Hills, Michigan 48301
    United States

    Active - Recruiting

  • Research Site

    Rochester, Minnesota 55905
    United States

    Active - Recruiting

  • Research Site

    Saint Louis, Missouri 63156
    United States

    Active - Recruiting

  • Research Site

    Maspeth, New York 11378
    United States

    Active - Recruiting

  • Research Site

    Port Jefferson Station, New York 11776
    United States

    Site Not Available

  • Research Site

    Durham, North Carolina 27705
    United States

    Site Not Available

  • Research Site

    Greenville, North Carolina 27834
    United States

    Site Not Available

  • Research Site

    New Bern, North Carolina 28562
    United States

    Terminated

  • Research Site

    Winston-Salem, North Carolina 27104
    United States

    Site Not Available

  • Research Site

    Philadelphia, Pennsylvania 19140
    United States

    Site Not Available

  • Research Site

    Pittsburgh, Pennsylvania 15213
    United States

    Site Not Available

  • Research Site

    Sayre, Pennsylvania 18840
    United States

    Site Not Available

  • Research Site

    Charleston, South Carolina 29414
    United States

    Site Not Available

  • Research Site

    Spartanburg, South Carolina 29303
    United States

    Site Not Available

  • Research Site

    Galveston, Texas 77555
    United States

    Active - Recruiting

  • Research Site

    Lewisville, Texas 75067
    United States

    Active - Recruiting

  • Research Site

    Mansfield, Texas 76063
    United States

    Active - Recruiting

  • Research Site

    McAllen, Texas 78503
    United States

    Site Not Available

  • Research Site

    McKinney, Texas 75069
    United States

    Site Not Available

  • Research Site

    Williamsburg, Virginia 23188
    United States

    Site Not Available

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