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Real World Evidence of Benralizumab in Eosinophilic Severe AsThma in Russia (BEST)

NCT05271526 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 3

Last updated 2024-10-21

No results posted yet for this study

Summary

Benralizumab is a humanised, afucosylated, monoclonal antibody against the interleukin (IL)-5 receptor (IL-5R) α subunit that induces direct, rapid, and near-complete depletion of eosinophils in blood, airway tissue, and bone marrow through enhanced antibody-dependent cell-mediated cytotoxicity (ADCC). This apoptotic process involves natural killer cells responsible for the controlled eosinophilic elimination. In the two pivotal phase III trials SIROCCO and CALIMA, benralizumab was well tolerated, significantly reduced asthma exacerbations by up to 51%, and improved lung function as well as disease control in patients with severe, uncontrolled asthma and blood eosinophil count of ≥ 300 cells/μL blood, receiving both ICS and LABA.

According to the summary of product's characteristics (SmPC) of benralizumab in Russia, it can be used for an add-on maintenance treatment for adult patients with severe eosinophilic asthma. All patients enrolled in the BEST study will comply with the SmPC approved by the Russian Ministry of Health.

Conditions

  • Severe Eosinophilic Asthma

Sponsors & Collaborators

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-16
Primary Completion
2023-11-13
Completion
2023-11-13

Countries

  • Russia

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05271526 on ClinicalTrials.gov