A Multicentre, Randomised, Double-blind, Parallel Group, Placebo-controlled, Time-to-first Asthma Exacerbation Phase III Efficacy and Safety Study of Benralizumab in Paediatric Patients With Severe Eosinophilic Asthma
Benralizumab: Benralizumab active solution will be administered SC to the patients.
Placebo: Placebo solution will be administered SC to the patients.
Study summary
A study to evaluate the efficacy and safety of benralizumab administered subcutaneously in patients ≥ 6 to \< 18 years of age with severe eosinophilic asthma, including a well-documented history of asthma exacerbations and uncontrolled asthma receiving high-dose inhaled corticosteroid (ICS) plus at least one additional controller medication.
Eligibility
Sex
ALL
Min age
6 Years
Max age
18 Years
Healthy volunteers
No
Inclusion Criteria:
* Capable of giving assent (signing the assent form) to participate in the study. The caregiver of the patient must be capable of giving written informed consent for the patient's participation in the study. Consent and assent forms must be completed prior to any study-specific procedures.
* Patient and the caregiver (where applicable) must be willing to and be able to answer questionnaires that are part of the study procedures.
* Male or female patients aged ≥ 6 to \< 18 years old.
* Patients with physician-diagnosed severe eosinophilic asthma for at least 12 months prior to Visit 1.
* Patients with a diagnosis of severe asthma confirmed, evaluated, and managed by the clinical site/site network for ≥ 6 months prior to Visit 1.
* Patients with an exacerbation history of asthma exacerbations (defined as a requirement for systemic corticosteroids and/or hospitalisation) within 12 months prior to Visit 1, OR,
1. 2 asthma exacerbations (defined as a requirement for systemic corticosteroids and/or hospitalisation) per year within the 2 years prior to Visit 1 AND, one or more of the following:
2. Currently on stable maintenance oral corticosteroids (OCS) used for at least 3 months prior to Visit 1, OR,
3. At least one of the 2 exacerbations that occurred in the year prior to Visit 1 resulted in hospitalisation.
* Patients on well-documented, stable treatment for asthma with high dose ICS and at least one additional controller medication, such as long-acting β2 agonists (LABA), leukotriene receptor antagonists (LTRA), long-acting muscarinic antagonists (LAMA), or theophylline, since at least 6 months prior to Visit 1.
* Eosinophilic airway inflammation that is related to asthma characterised as eosinophilic in nature as indicated by peripheral blood eosinophil count of ≥ 300 cells/μL during screening OR a blood eosinophil count of 150 to 299 cells/μL during screening and documentation of elevated eosinophils in bronchoalveolar lavage (BAL), sputum, bronchial biopsy, or historical eosinophil count ≥ 300 cells/μL within the 2 years prior to Visit 1.
* ≥ 70% compliance with maintenance asthma medication during the screening period based on the Paediatric Asthma Symptom - Observer reported (PASO) or Asthma Daily Diary.
* At least 50% daily PASO or Asthma Daily Diary completion during the entire screening period, with at least 50% PASO or Asthma Daily Diary completion in the 14-day period prior to randomisation.
* ACQ-IA ≥ 1.5 at screening and Visit 2a.
* Body weight ≥ 15 kg.
* Females of childbearing potential (FOCBP) who are sexually active, as judged by the investigator, must commit to consistent and correct use of a highly effective method of contraception.
Exclusion Criteria:
* Clinically important pulmonary disease other than asthma or patients who have ever been diagnosed with pulmonary or systemic disease, other than asthma, that are associated with elevated peripheral eosinophil counts.
* Life-threatening asthma.
* Asthma exacerbation requiring use of systemic corticosteroids or increase in maintenance dose of OCS within 2 weeks prior to Visit 2a or acute upper/lower respiratory infection that requires antibiotics or antiviral medication within 2 weeks prior to the first dose of the IP (Visit 2b).
* Any disorder that is not stable in the opinion of the investigator and could affect the safety of the patient during the study, influence the findings of the studies or their interpretations or impede the patient's ability to complete the entire duration of the study.
* History of anaphylaxis to any biologic therapy.
* Current malignancy, or history of malignancy.
* A helminth parasitic infection.
* Use of immunosuppressive medication.
* Receipt of immunoglobulin or blood products within 30 days prior to Visit 1.
* Receipt of any marketed or investigational biologic within 5 half-lives prior to Visit 2.
* Previously received benralizumab (MEDI-563).
* Participation in another interventional clinical study.
* Patients with known hypersensitivity to benralizumab or any of the excipients of the product.
* Currently pregnant, breastfeeding, or lactating females.
* Previous randomisation in the present study.
Primary outcome measure(s)
Time to first asthma exacerbation — From Baseline (Week 0) to End of Treatment (EOT) in DB treatment period The effect of benralizumab on asthma exacerbations in paediatric and adolescent patients with uncontrolled asthma will be evaluated.
Trial sites (43)
Facility
City
Region
Status
Research Site
Torrance
California
Research Site
Ocala
Florida
Research Site
Owensboro
Kentucky
Research Site
Lafayette
Louisiana
Research Site
Kansas City
Missouri
Research Site
Northfield
New Jersey
Research Site
The Bronx
New York
Research Site
Cincinnati
Ohio
Research Site
Charleston
South Carolina
Research Site
San Antonio
Texas
Research Site
Tyler
Texas
Research Site
Ciudad de Buenos Aires
Argentina
Research Site
Ciudad de Buenos Aire
Argentina
Research Site
Florida
Argentina
Research Site
Lobos
Argentina
Research Site
Mar del Plata
Argentina
Research Site
Mendoza
Argentina
Research Site
Mendoza
Argentina
Research Site
Rosario
Argentina
Research Site
San Juan Bautista
Argentina
Research Site
Santa Fe
Argentina
Research Site
Créteil
France
Research Site
Lyon
France
Research Site
Rouen
France
Research Site
Milan
Italy
Research Site
Roma
Italy
Research Site
Bialystok
Poland
Research Site
Krakow
Poland
Research Site
Lodz
Poland
Research Site
Skarżysko-Kamienna
Poland
Research Site
Tarnów
Poland
Research Site
Cheongju-si
South Korea
Research Site
Junggu
South Korea
Research Site
Seoul
South Korea
Research Site
Seoul
South Korea
Research Site
Badalona
Spain
Research Site
Barcelona
Spain
Research Site
Benalmádena
Spain
Research Site
Esplugues de Llobregat
Spain
Research Site
Kaohsiung City
Taiwan
+ 3 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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