BRISOTE: A Multicentre, Randomised, Double-blind, Parallel Group, Active-Controlled, Phase 3b Study to Evaluate the Efficacy and Safety of Benralizumab 30 mg SC in Eosinophilic Asthma Patients Uncontrolled on Medium-Dose Inhaled Corticosteroid Plus Long-acting β2 Agonist

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-515162-13-00

Acronym

D3250C00101

Enrollment

172

Registered

2025-03-17

Start date

2025-04-29

Completion date

Unknown

Last updated

2025-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Eosinophilic Asthma

Brief summary

Endpoint: AAER during the 48-week treatment period.

Detailed description

Change from baseline in SGRQ total score to EOT (Week 48)

Interventions

DRUGFasenra 30 mg solution for injection in pre-filled syringe

DRUGSymbicort Turbuhaler 160 microgramos/4

DRUG5 microgramos/inhalación polvo para inhalación

DRUGPlacebo for Benralizumab

DRUGSymbicort forte Turbuhaler 320 microgramos/9 microgramos/inhalación polvo para inhalación.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Endpoint: AAER during the 48-week treatment period.	—

Secondary

Measure	Time frame
Change from baseline in SGRQ total score to EOT (Week 48)	—

Countries

Bulgaria, France, Germany, Ireland, Italy, Norway, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026

BRISOTE: A Multicentre, Randomised, Double-blind, Parallel Group, Active-Controlled, Phase 3b Study to Evaluate the Efficacy and Safety of Benralizumab 30 mg SC in Eosinophilic Asthma Patients Uncontrolled on Medium-Dose Inhaled Corticosteroid Plus Long-acting β2 Agonist