Efficacy and Safety of Benralizumab in Paediatric Patients With Severe Eosinophilic Asthma (DOMINICA)
AstraZeneca
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.
Description
A randomised, double-blind, parallel-group, placebo-controlled, time-to-first-asthma-exacerbation event study designed. There will be a screening period of 2 months to allow adequate time for the eligibility criteria to be evaluated. The screening period may be reduced to not lesser than 4 weeks from Visit 2a. Furthermore, the Screening Period may be extended up to 12 weeks (or longer, if deemed necessary by the investigator), to accommodate treatment. Visit 2 will be split into Part A (Visit 2a) and Part B (Visit 2b) to reassess eligibility prior to randomisation and first dose of study tre…
Eligibility
- Age range
- 6–18 years
- Sex
- All
- 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…
Interventions
- DrugBenralizumab
Benralizumab active solution will be administered SC to the patients.
- DrugPlacebo
Placebo solution will be administered SC to the patients.
Locations (116)
- Research SiteMobile, Alabama
- Research SiteMontgomery, Alabama
- Research SiteTucson, Arizona
- Research SiteLittle Rock, Arkansas
- Research SiteMadera, California
- Research SiteTorrance, California