Benralizumab for Severe Eosinophilic Asthma
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)
- Age
- 6 – 18
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 200 (estimated)
- Sponsor
- AstraZeneca · Industry
This trial is looking for children aged 6 to under 18 with severe eosinophilic asthma. Participants will receive injections of a medication called benralizumab and will need to answer questions about their asthma periodically.
You may be able to join if
- I am between 6 and 18 years old.
- I have been diagnosed with severe eosinophilic asthma for at least 12 months.
- I have a history of asthma exacerbations in the last year.
- I am currently using high-dose inhaled corticosteroids and another asthma medication.
- I have a blood eosinophil count of at least 300 cells/μL.
- I weigh at least 15 kg.
- I can complete questionnaires about my asthma.
- I have been compliant with my asthma medications.
You may not be able to join if
- I have a serious lung disease other than asthma.
- I have had a life-threatening asthma event.
- I have had an asthma exacerbation that required corticosteroids in the last 2 weeks.
- I have a history of severe allergic reactions to any biologic therapy.
- I am pregnant, breastfeeding, or lactating.
- I have a current or past cancer.
- I have taken any immunosuppressive medication recently.
- I am participating in another clinical study.
Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.
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Check Your EligibilityA 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.
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AstraZeneca Clinical Study Information Center
1-877-240-9479
information.center@astrazeneca.com
CONTACT