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)

Recruiting Phase 3 Interventional Study
Asthma
Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
6 – 18
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
200 (estimated)
Sponsor
AstraZeneca · Industry
Who this trial is looking for

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.

Are You a Good Fit for This Trial?
Must be taking High-dose inhaled corticosteroidsAdditional asthma controller medication

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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About This Trial

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.

Trial Locations
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Eligibility Criteria
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 …
Contacts

AstraZeneca Clinical Study Information Center

1-877-240-9479

information.center@astrazeneca.com

CONTACT