🅇
Currently Recruiting
This trial is actively seeking participants in the UK. Discuss eligibility with your patient.
Status
Recruiting
Phase
PHASE3
NCT ID
NCT05692180

Trial 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.

Sponsor: AstraZeneca
Participants: ALL
Start: 2023-04-05
Completion: 2030-05-05
Min Age: 6 Years
Max Age: 18 Years

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 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 to Visit 1. * Patients with a diagnosis of severe asthma confirmed, evaluated, and managed by the clinical site/site network for ≥ 6 months prior to Visit 1. * Patients with an exacerbation history of asthma exacerbations (defined as a requirement for systemic corticosteroids and/or hospitalisation) within 12 months prior to Visit 1, OR, 1. 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: 2. Currently on stable maintenance oral corticosteroids (OCS) used for at least 3 months prior to Visit 1,…

Data from ClinicalTrials.gov. Always verify on the primary source before clinical use.

Share: 𝕏 Twitter/X 🔗 LinkedIn View on Source ↗

More in Respiratory / COPD / Asthma