NCT04108962

Benralizumab in the Treatment of Patients With Severe Asthma With ABPA

Phase IV, Single-Center, Open-Label Study Evaluating the Effects of an Anti-IL5 Receptor Alpha (Benralizumab) Monoclonal Antibody in the Treatment of Severe Asthma in Patients With Allergic Bronchopulmonary Aspergillosis

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Baylor Research Institute · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Phase IV, open-label study will evaluate effects of Benralizumab in the treatment of severe asthma in patients with allergic bronchopulmonary aspergillosis

Detailed description

Subjects who have been identified to have severe asthma with ABPA will be consented and enrolled in the study to receive benralizumab injections administered every 4 weeks for the first 3 injections with an additional injection eight weeks to follow for a total of 16 weeks active treatment with a follow-up/termination visit eight weeks from the last injection. The termination visit will occur week 24 for subjects who complete the study treatment. Subjects who receive the first dose of benralizumab but withdraw from the study or terminate study treatment for any reason should complete all the procedures outlined for the termination visit.

Conditions

• ABPA
• Severe Asthma
• Allergic Bronchopulmonary Aspergillosis

Interventions

Type	Name	Description
DRUG	Fasenra, 30 Mg/mL Subcutaneous Solution	Anti-IL5 receptor alpha monoclonal antibody

Timeline

• Start date: 2019-12-23
• Primary completion: 2021-09-24
• Completion: 2021-10-01
• First posted: 2019-09-30
• Last updated: 2022-02-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study