Informations générales (source: ClinicalTrials.gov)
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.
Interventional
Phase 3
AstraZeneca (Voir sur ClinicalTrials)
mars 2025
novembre 2027
02 octobre 2025
This study evaluates the efficacy and safety of benralizumab as an add-on therapy in
uncontrolled eosinophilic asthma participants treated with medium-dose ICS-LABA compared
to the conventional treatment step of escalation of inhaled therapy to high-dose
ICS-LABA.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CHI DE CRETEIL | AMEL BOUDJEMAA | 28/08/2025 16:30:32 | Contacter | ||
| HOPITAL FOCH | COLAS TCHERAKIAN | 20/10/2025 07:27:07 | Contacter | ||
Critères
Tous
- Written informed consent
- Participant must be 12 to 75 years of age
- Documented history of physician-diagnosed asthma requiring treatment with at least
medium-dose ICS (> 250 μg fluticasone dry powder formulation equivalents total daily
dose) and a LABA, for at least 12 months prior to Visit (V) 1.
- Documented treatment with medium-dose ICS and LABA for at least 3 months prior to
Visit 1 with or without additional asthma controllers (excluding oral
corticosteroids).
- Weight of ≥ 35 kg.
- Pre-Bronchodilator (BD) Forced expiratory volume in 1 second (FEV1) of ≤ 90%
predicted
- Documented at least 2 asthma exacerbations in the 12 months prior to the date of
informed consent.
- ACQ-6 score ≥ 1.5 at Visit 1, plus at least once in the run-in period (from V2 to
V3) and at V3.
- Evidence of asthma as documented by excessive variability in lung function, as
defined in the protocol.
- Peripheral blood eosinophil count of ≥ 150 cells/μL, as defined in the protocol.
- At least 70% compliance with usual asthma controller ICS-LABA during run-in period
(from Visit 2 to Visit 3) based on asthma daily diary.
Exclusion Criteria:
- Important pulmonary disease other than asthma at the discretion of the investigator,
or ever been diagnosed with pulmonary or systemic disease, other than asthma, which
are associated with elevated peripheral eosinophil counts.
- Asthma exacerbation requiring use of Systemic corticosteroids (SCS), or acute
upper/lower respiratory infection that requires antibiotics or antiviral medication
within 30 days prior to the date informed consent is obtained or during the
screening/run-in period
- Any unstable disorder that in the opinion of the investigator could affect the study
according to the study protocol.
- Clinically significant chronic or ongoing active infections requiring systemic
treatment (at investigator's discretion)
- Concurrent participation in another clinical study with an IP or a
post-authorisation safety study.
- History of alcohol or drug abuse within 12 months prior to the date informed consent
is obtained.
- Current smokers or former smokers with a smoking history ≥ 10 pack-years. Former
smokers must have stopped for at least 6 months prior to Visit 1 to be eligible.