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
Location: See all (131) locations...
Intervention Type: Combination product
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Maximum Age: 75
Healthy Volunteers: f
View:

• 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.

Locations
United States
Arizona
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Chandler
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Sun City
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Tucson
California
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Bakersfield
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Inglewood
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Newport Beach
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Pasadena
Colorado
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Denver
Florida
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Cape Coral
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Lauderdale Lakes
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Leesburg
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Miami
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Orlando
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Tampa
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Winter Park
Michigan
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Ann Arbor
New Jersey
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Northfield
Nevada
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Henderson
New York
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New Hyde Park
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The Bronx
Oklahoma
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Oklahoma City
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Oklahoma City
Pennsylvania
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Dubois
Rhode Island
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Warwick
South Carolina
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Greenville
Texas
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Mckinney
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San Antonio
Other Locations
Bulgaria
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Plovdiv
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Rousse
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Sofia
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Sofia
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Stara Zagora
Canada
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Ajax
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Edmonton
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Kamloops
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Québec
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Sainte-foy
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Toronto
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Vancouver
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Windsor
China
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Beijing
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Beijing
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Changsha
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Chongqing
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Fuzhou
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Guangzhou
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Guangzhou
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Hangzhou
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Hangzhou
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Hefei
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Huizhou
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Jinan
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Qinhuangdao
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Shanghai
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Shanghai
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Wenzhou
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Wuhan
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Xuzhou
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Yinchuan
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Zhengzhou
France
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Bayonne
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Créteil
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La Tronche
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Lyon
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Montpellier
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Pessac
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Suresnes
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Toulouse
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Villeurbanne
Germany
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Berlin
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Berlin
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Cottbus
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Delitzsch
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Geesthacht
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Lübeck
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München
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Wiesbaden
Hong Kong Special Administrative Region
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Hong Kong
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Pok Fu Lam
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Shatin
Ireland
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Ballinasloe
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Cork
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Dublin
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Moneymore
Italy
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Bari
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Bergamo
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Brescia
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Cagliari
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Catanzaro
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Genoa
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Milan
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Modena
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Montebelluna
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Napoli
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Roma
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Roma
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Rozzano
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Verona
Norway
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Lørenskog
Spain
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Alcorcón
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Alzira (valencia)
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Badalona
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Barakaldo
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Barcelona
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Barcelona
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Burgos
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Cáceres
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Granada
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Jerez De La Frontera
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Lugo
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Madrid
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Madrid
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Málaga
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Marbella
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Marbella
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Mérida
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Palma De Mallorca
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Santander
Switzerland
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Aarau
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Basel
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Lausanne
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Sankt Gallen
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Sion
United Kingdom
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Belfast
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Birmingham
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Bradford
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Bristol
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Chorley
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Leeds
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Nottingham
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WITHDRAWN
Portsmouth
Contact Information
Primary
AstraZeneca Clinical Study Information Center
information.center@astrazeneca.com
1-877-240-9479
Time Frame
Start Date: 2025-03-28
Estimated Completion Date: 2027-11-02
Participants
Target number of participants: 400
Treatments
Active_comparator: Medium-dose ICS-LABA + benralizumab
Participants will be randomised 1:1 to one of the 2 study arms. Participants will receive up to 7 SC injections during study, with the first 3 doses administered every 4 weeks and then subsequent doses every 8 weeks.
Active_comparator: High-dose ICS-LABA + placebo
Participants will be randomised 1:1 to one of the 2 study arms. Participants will receive up to 7 SC injections during study, with the first 3 doses administered every 4 weeks and then subsequent doses every 8 weeks.
Related Therapeutic Areas
Sponsors
Leads: AstraZeneca

This content was sourced from clinicaltrials.gov