Efficacy and Safety Study of Benralizumab in Patients With Uncontrolled Asthma on Medium to High Dose Inhaled Corticosteroid Plus LABA (MIRACLE)

Summary

This is a randomised, double-blind, parallel group, placebo-controlled study designed to evaluate the efficacy and safety of a fixed 30 mg dose of benralizumab administered subcutaneously for patients with a history of asthma exacerbations and uncontrolled asthma receiving medium to high-dose inhaled corticosteroid plus long-acting β2-agonist (ICS-LABA) with or without oral corticosteroids and additional asthma controllers.

Timeline

Start

2017-09-07

Primary completion

2023-01-30

Completion

2023-01-30

Outcome

Met primary endpoint

registry analysis (superiority test); Benralizumab 30 mg vs Placebo; p <0.0001; Rate Ratio 0.26 (95% CI 0.19 to 0.36) NCT03186209 ↗

Publications

• Jin Y, Guiastrennec B, Stuke M, Yao Y, Zhang Y, Barker P, Jison M, Penland RC, Ding J, Lukka PB. Population Pharmacokinetics and Exposure-Response Analysis of Benralizumab in Chinese Adults, Adolescents, and Pediatric Participants with Severe Eosinophilic Asthma. Clin Pharmacokinet. 2025 Aug;64(8):1231-1243. doi: 10.1007/s40262-025-01538-9. Epub 2025 Jun 23.

Drugs

Indications