RECRUITING

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 (DOMINICA)

Conditions

Asthma Eosinophilic asthma Pediatric Patients Severe asthma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-04-05

Study Completion:2032-05-16

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05692180

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:6 Years to 18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT

Inclusion Criteria	Exclusion 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 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, 1. 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: 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 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	* 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 4 months or 5 half-lives prior to Visit 1 * 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.

Inclusion Criteria

Exclusion 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 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,
1. 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:
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 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

* 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 4 months or 5 half-lives prior to Visit 1
* 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.

Contacts and Locations

Study Contact

AstraZeneca Clinical Study Information Center

CONTACT

1-877-240-9479

information.center@astrazeneca.com

Study Locations (Sites)

Research Site

Mobile, Alabama, 36608

United States

Research Site

Montgomery, Alabama, 36106

United States

Research Site

Tucson, Arizona, 85724

United States

Research Site

Little Rock, Arkansas, 72202

United States

Research Site

Madera, California, 93636

United States

Research Site

Washington, District of Columbia, 20010

United States

Research Site

Miami, Florida, 33144

United States

Research Site

Miami, Florida, 33184

United States

Research Site

Ocala, Florida, 34471

United States

Research Site

Owensboro, Kentucky, 42301

United States

Research Site

Lafayette, Louisiana, 70508

United States

Research Site

New Orleans, Louisiana, 70112

United States

Research Site

Glenn Dale, Maryland, 20769

United States

Research Site

Kansas City, Missouri, 64108

United States

Research Site

Lincoln, Nebraska, 68510

United States

Research Site

Brick, New Jersey, 08724

United States

Research Site

Northfield, New Jersey, 08225

United States

Research Site

Bronx, New York, 10459

United States

Research Site

Cincinnati, Ohio, 45229

United States

Research Site

Cleveland, Ohio, 44106

United States

Research Site

Charleston, South Carolina, 29425

United States

Research Site

Dallas, Texas, 75235

United States

Research Site

San Antonio, Texas, 78229

United States

Research Site

Tyler, Texas, 75708

United States

Research Site

Morgantown, West Virginia, 26506

United States

Collaborators and Investigators

Sponsor: AstraZeneca

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-04-05

Study Completion Date2032-05-16

Study Record Updates

Study Start Date2023-04-05

Study Completion Date2032-05-16

Terms related to this study

Keywords Provided by Researchers

Eosinophilic asthma
Pediatric Patients
Severe asthma

Additional Relevant MeSH Terms

Asthma