Efficacy and Safety of Benralizumab in Paediatric Patients With Severe Eosinophilic Asthma (DOMINICA)

Status: Recruiting
Location: See all (84) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 6
Maximum Age: 18
Healthy Volunteers: f
View:

• 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 a diagnosis of eosinophilic asthma, defined by regional for at least 12 months prior to Visit 1.

• Patients with a diagnosis of severe asthma confirmed, evaluated, and managed by the clinical site for ≥ 6 months prior to Visit 1.

• Patients with an exacerbation history of asthma exacerbations (defined as a requirement for systemic corticosteroids and/or hospitalization) within 12 months prior to Visit 1, OR,

‣ 2 asthma exacerbations (defined as a requirement for systemic corticosteroids and/or hospitalization) per year within the 2 years prior to Visit 1 AND, one or more of the following:

⁃ Currently on stable maintenance oral corticosteroids (OCS) used for at least 3 months prior to Visit 1, OR,

⁃ 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 1 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 and documentation of elevated eosinophils in bronchoalveolar lavage (BAL), sputum, or bronchial biopsy 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 70% 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.

• Pre-BD FEV1 ≤ 95% PN or pre-BD FEV1/FVC ratio \< 0.85 required. Patients with ≥ 25 % increase in mean pre-BD FEV1 value during the screening period will be screen failed.

• ACQ-IA ≥ 1.5 with no meaningful improvement (ACQ-IA change ≤ -0.5) between 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 and acceptable method of contraception

Locations
United States
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Tucson
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Madera
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Washington
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Miami
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Miami
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Ocala
Kentucky
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Owensboro
Louisiana
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Lafayette
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New Orleans
Maryland
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Glenn Dale
Missouri
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Kansas City
Nebraska
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Lincoln
New Jersey
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Brick
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Northfield
New York
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Bronx
Ohio
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Cincinnati
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Cleveland
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Charleston
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West Virginia
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Argentina
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Ciudad De Buenos Aire
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Florida
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Lobos
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Mendoza
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Rosario
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Santa Fe
Canada
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Burlington
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Edmonton
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Hamilton
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Montreal
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Quebec
France
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Creteil
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Lyon
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Toulouse Cedex 9
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Essen
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Italy
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Genova
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Milano
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Pavia
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Ponte San Pietro
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Roma
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Roma
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Verona
Poland
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Bialystok
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Krakow
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Łódź
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Skarżysko-kamienna
Republic of Korea
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Cheongju-si
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Jung-gu
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Seoul
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Seoul
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Seoul
Spain
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Badalona
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Barcelona
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Benalmádena
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Cartagena
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Esplugues De Llobregat
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Madrid
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Mérida
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Valencia
Taiwan
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Changhua
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Kaohsiung
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Taichung
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Taipei
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Taoyuan
United Kingdom
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Glasgow
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Leicester
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London
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London
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Manchester
Contact Information
Primary
AstraZeneca Clinical Study Information Center
information.center@astrazeneca.com
1-877-240-9479
Time Frame
Start Date: 2023-04-05
Estimated Completion Date: 2032-05-16
Participants
Target number of participants: 200
Treatments
Experimental: Benralizumab
Patients will receive Benralizumab as an active solution via a subcutaneous (SC) injection.
Placebo_comparator: Placebo
Patients will receive a matching solution of the placebo via SC injection.
Related Therapeutic Areas
Sponsors
Leads: AstraZeneca
Collaborators: Parexel

This content was sourced from clinicaltrials.gov