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) - DOMINICA

Study identifier:D3250C00024

ClinicalTrials.gov identifier:NCT05692180

EudraCT identifier:N/A

CTIS identifier:2022-501344-14-00

Recruiting

Official Title

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

Medical condition

asthma

Phase

Phase 3

Healthy volunteers

No

Study drug

Benralizumab, Placebo

Sex

All

Estimated Enrollment

200

Study type

Interventional

Age

6 Years - 18 Years

Date

Study Start Date: 05 Apr 2023
Estimated Primary Completion Date: 05 May 2030
Estimated Study Completion Date: 16 May 2032

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 Aug 2024 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

PAREXEL

Inclusion and exclusion criteria