Predictive Signature of Benralizumab Response (BENRAPRED)

NCT04565483 Phase 4 RECRUITING

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)

Details

Lead sponsor	Nantes University Hospital
Phase	Phase 4
Status	RECRUITING
Enrolment	220
Start date	2021-10-11
Completion	2026-11

Conditions

• Asthma; Eosinophilic
• Severe Asthma

Interventions

• Benralizumab Prefilled Syringe

Primary outcomes

• Predictive value of early blood gene expression signature of Benralizumab — 12 months
  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. We will evaluate an early blood gene expression signature of Benralizumab response through a clinically relevant reduction of the number of exacerbations at month 12 (M12).

Countries

France