RecruitingPhase 3

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)

United States200 participantsStarted 2023-04-05

Plain-language 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.

Who can participate

Age range6 Years – 18 Years

SexALL

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Inclusion criteria

✓. 2 asthma exacerbations (defined as a requirement for systemic corticosteroids and/or hospitalisation) 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.

What they're measuring

Time to first asthma exacerbation

Timeframe: From Baseline (Week 0) to End of Treatment (EOT) in DB treatment period

Trial details

NCT IDNCT05692180

SponsorAstraZeneca

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2030-05-05

Contact for this trial

AstraZeneca Clinical Study Information Center

1-877-240-9479 information.center@astrazeneca.com

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