NCT04565483

Predictive Signature of Benralizumab Response

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 220 (estimated)
• Sponsor: Nantes University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The objective of the study is to establish the predictive value of early blood gene expression signature of Benralizumab response associated with a significant reduction of the number of exacerbations in treated severe asthmatic patients. This trial is a French, multicenter and no-randomized trial. Patients enrolled will be clinically followed for 16 months (the treatment period: 12 months and 1 month follow-up; 6 clinical visit on site and in phone call at 13 months)

Conditions

• Asthma; Eosinophilic
• Severe Asthma

Interventions

Type	Name	Description
DRUG	Benralizumab Prefilled Syringe	Patients receive BENRALIZUMAB if they meet the criteria for inclusion and non-inclusion at the inclusion visit. Injections take place at the inclusion visit, at 1 month, 2 months, 4 months, 6 months, 8 months, 10 months and 12 months.

Timeline

• Start date: 2021-10-11
• Primary completion: 2026-10-01
• Completion: 2026-11-01
• First posted: 2020-09-25
• Last updated: 2024-04-26

Locations

20 sites across 1 country: France