Benralizumab Airway Remodeling Study in Severe Eosinophilic Asthmatics
NCT ID: NCT03953300
Last Updated: 2025-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
PHASE4
75 participants
INTERVENTIONAL
2019-10-08
2026-09-09
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Benralizumab
Administrated subcutaneously (SC) every 4 weeks for the first 3 doses, then every 8 weeks
Benralizumab
Benralizumab: 30 mg/mL solution for injection in accessorized prefilled syringe (APFS) will be administered subcutaneously (SC) every 4 weeks for the first 3 doses - Weeks 0, 4 and 8, and then every 8 weeks - Weeks 16, 24, 32, 40.
Placebo
Administrated subcutaneously every 4 weeks for the first 3 doses, then every 8 weeks
Placebo
Matching placebo will be administered subcutaneously with accessorized prefilled syringe (APFS) every 4 weeks for the first 3 doses - Weeks 0, 4 and 8, and then every 8 weeks - Weeks 16, 24, 32, 40.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Benralizumab
Benralizumab: 30 mg/mL solution for injection in accessorized prefilled syringe (APFS) will be administered subcutaneously (SC) every 4 weeks for the first 3 doses - Weeks 0, 4 and 8, and then every 8 weeks - Weeks 16, 24, 32, 40.
Placebo
Matching placebo will be administered subcutaneously with accessorized prefilled syringe (APFS) every 4 weeks for the first 3 doses - Weeks 0, 4 and 8, and then every 8 weeks - Weeks 16, 24, 32, 40.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Physician-diagnosed asthma requiring continuous treatment with medium- or high-dose ICS plus LABA with or without additional controller medication for at least 12 months prior to Visit 1, and current treatment with high-dose ICS plus LABA for at least 3 months prior to Visit 1 with or without additional asthma maintenance medication.
3. Morning pre-BD FEV1 ≥50 to \<80% of predicted normal value (PNV) and ≥1 liter (L) or morning pre-BD FEV1 ≥ 50 to \< 90% of PNV, if historical pre-BD FEV1 value (within 12 months prior to screening visit) was \< 80% of PNV.
4. A blood eosinophil count meeting any of 3 criteria: ≥300 cells/µL during screening or ≥ 220 to \< 300 cells/μL during screening and documented eosinophil count of ≥ 300 cells/μL in the past 12 months, or ≥150 to \<300 cells/µL during screening plus one of 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 Criteria
* current smokers
* history of cancer
* life-threatening asthma
* clinically important pulmonary disease other than asthma
2. Use of chronic immunosuppressive medication or receipt of immunoglobulin (or blood products) within 30 days prior to the date informed consent is obtained.
3. 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 the date informed consent is obtained, whichever is longer.
* any marketed or investigational biologic for the treatment of asthma within 4 months (or 5 half-lives) prior to the date informed consent is obtained, whichever is longer.
4. Currently pregnant, breastfeeding or lactating women.
18 Years
70 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
AstraZeneca
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Mario Castro, MD
Role: PRINCIPAL_INVESTIGATOR
University of Kansas School of Medicine 3901 Rainbow Blvd. Kansas City, KS 66160, USA
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Research Site
Birmingham, Alabama, United States
Research Site
Los Angeles, California, United States
Research Site
Jacksonville, Florida, United States
Research Site
Miami, Florida, United States
Research Site
Snellville, Georgia, United States
Research Site
Indianapolis, Indiana, United States
Research Site
Iowa City, Iowa, United States
Research Site
Kansas City, Kansas, United States
Research Site
Ann Arbor, Michigan, United States
Research Site
Bloomfield Hills, Michigan, United States
Research Site
Rochester, Minnesota, United States
Research Site
St Louis, Missouri, United States
Research Site
Maspeth, New York, United States
Research Site
New Bern, North Carolina, United States
Research Site
Winston-Salem, North Carolina, United States
Research Site
Pittsburgh, Pennsylvania, United States
Research Site
Galveston, Texas, United States
Research Site
Lewisville, Texas, United States
Research Site
Mansfield, Texas, United States
Research Site
Calgary, Alberta, Canada
Research Site
Aalborg, , Denmark
Research Site
Aarhus N, , Denmark
Research Site
Copenhagen, , Denmark
Research Site
Hvidovre, , Denmark
Research Site
Næstved, , Denmark
Research Site
Odense C, , Denmark
Research Site
Vejle, , Denmark
Research Site
Gothenburg, , Sweden
Research Site
Lund, , Sweden
Research Site
Cambridge, , United Kingdom
Research Site
Headington, , United Kingdom
Research Site
Leicester, , United Kingdom
Research Site
Liverpool, , United Kingdom
Research Site
London, , United Kingdom
Research Site
Wythenshawe, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2018-003391-13
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
D3250C00059
Identifier Type: -
Identifier Source: org_study_id