Randomised Clinical Trial to Investigate Efficacy and Safety of Benralizumab 30 mg SC as an add-on Therapy in Uncontrolled Eosinophilic Asthma Patients Treated With Medium-dose ICS-LABA Compared to Conventional Escalation to High-dose ICS-LABA Treatment
BRISOTE
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.
1 other identifier
interventional
400
13 countries
157
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Mar 2025
Typical duration for phase_3
157 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 20, 2024
CompletedFirst Posted
Study publicly available on registry
December 27, 2024
CompletedStudy Start
First participant enrolled
March 28, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 3, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 3, 2027
March 19, 2026
March 1, 2026
2.6 years
November 20, 2024
March 18, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Annualized asthma exacerbation rate
To assess asthma exacerbation rate.
Baseline through Week 48
Secondary Outcomes (7)
Change in Saint George's Respiratory Questionnaire (SGRQ) total score
Baseline through Week 48
Change in pre-bronchodilator FEV1
Baseline through Week 48
Change in Asthma control questionnaire (ACQ) scale score.
Baseline through Week 48.
Time to first asthma exacerbation
Baseline through Week 48.
Annualized asthma exacerbation rate associated with an emergency/urgent care visit or a hospitalization
Baseline through Week 48.
- +2 more secondary outcomes
Study Arms (2)
Medium-dose ICS-LABA + benralizumab
ACTIVE COMPARATORParticipants 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.
High-dose ICS-LABA + placebo
ACTIVE COMPARATORParticipants 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.
Interventions
ICS-LABA inhalation
Placebo for Benralizumab (aka, "placebo"). SC injection.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (157)
Research Site
Chandler, Arizona, 85224, United States
Research Site
Sun City, Arizona, 85351, United States
Research Site
Tucson, Arizona, 85704, United States
Research Site
Bakersfield, California, 93301, United States
Research Site
Inglewood, California, 90301, United States
Research Site
Modesto, California, 95355, United States
Research Site
Newport Beach, California, 92663, United States
Research Site
Pasadena, California, 91101, United States
Research Site
Denver, Colorado, 80206, United States
Research Site
Cape Coral, Florida, 33990, United States
Research Site
Hialeah, Florida, 33015, United States
Research Site
Lauderdale Lakes, Florida, 33313, United States
Research Site
Leesburg, Florida, 34748, United States
Research Site
Miami, Florida, 33122, United States
Research Site
Miami, Florida, 33155, United States
Research Site
Miami, Florida, 33175, United States
Research Site
Orlando, Florida, 32819, United States
Research Site
Plantation, Florida, 33324, United States
Research Site
Tampa, Florida, 33607, United States
Research Site
Winter Park, Florida, 32789, United States
Research Site
Ann Arbor, Michigan, 48109, United States
Research Site
Henderson, Nevada, 89052, United States
Research Site
Northfield, New Jersey, 08225, United States
Research Site
Union City, New Jersey, 07087, United States
Research Site
New Hyde Park, New York, 11042, United States
Research Site
The Bronx, New York, 10459, United States
Research Site
Oklahoma City, Oklahoma, 73103, United States
Research Site
Oklahoma City, Oklahoma, 73111, United States
Research Site
DuBois, Pennsylvania, 15801, United States
Research Site
Warwick, Rhode Island, 02886, United States
Research Site
Greenville, South Carolina, 29607, United States
Research Site
Houston, Texas, 77099, United States
Research Site
McKinney, Texas, 75069, United States
Research Site
San Antonio, Texas, 78251, United States
Research Site
Dimitrovgrad, 6400, Bulgaria
Research Site
Haskovo, 6300, Bulgaria
Research Site
Pleven, 5800, Bulgaria
Research Site
Plovdiv, 4002, Bulgaria
Research Site
Plovdiv, 4023, Bulgaria
Research Site
Rousse, 7002, Bulgaria
Research Site
Sofia, 1142, Bulgaria
Research Site
Sofia, 1431, Bulgaria
Research Site
Stara Zagora, 6000, Bulgaria
Research Site
Stara Zagora, 6000, Bulgaria
Research Site
Edmonton, Alberta, T6G 2C8, Canada
Research Site
Kamloops, British Columbia, V2C 5T1, Canada
Research Site
Vancouver, British Columbia, V5Z 1M9, Canada
Research Site
Ajax, Ontario, L1S 2J5, Canada
Research Site
Toronto, Ontario, M5T 3A9, Canada
Research Site
Windsor, Ontario, N8X 1T3, Canada
Research Site
Québec, Quebec, G1G 3Y8, Canada
Research Site
Sainte-Foy, Quebec, G1V 4G5, Canada
Research Site
Beijing, 100020, China
Research Site
Beijing, 100044, China
Research Site
Beijing, 102218, China
Research Site
Changsha, 410004, China
Research Site
Chongqing, 400042, China
Research Site
Fuzhou, 350001, China
Research Site
Fuzhou, 350005, China
Research Site
Fuzhou, 350008, China
Research Site
Guangzhou, 510120, China
Research Site
Guangzhou, 510180, China
Research Site
Hangzhou, 31000, China
Research Site
Hangzhou, 310014, China
Research Site
Hefei, 230061, China
Research Site
Huizhou, 516002, China
Research Site
Jinan, 250021, China
Research Site
Linyi, 276100, China
Research Site
Ningbo, 315020, China
Research Site
Qinhuangdao, China
Research Site
Shanghai, 200080, China
Research Site
Shanghai, 200433, China
Research Site
Wenzhou, 325027, China
Research Site
Wuhan, 430030, China
Research Site
Xuzhou, 221000, China
Research Site
Yinchuan, 750004, China
Research Site
Zhengzhou, 450000, China
Research Site
Bayonne, 64109, France
Research Site
Créteil, 94010, France
Research Site
La Tronche, 38043, France
Research Site
Lyon, 69317, France
Research Site
Montpellier, 34295, France
Research Site
Pessac, F-33604, France
Research Site
Suresnes, 92150, France
Research Site
Toulouse, 31059, France
Research Site
Villeurbanne, 69100, France
Research Site
Berlin, 10367, Germany
Research Site
Berlin, 10717, Germany
Research Site
Bonn, 53119, Germany
Research Site
Cottbus, 03050, Germany
Research Site
Delitzsch, 4509, Germany
Research Site
Geesthacht, 21502, Germany
Research Site
Landsberg, 86899, Germany
Research Site
Lübeck, 23552, Germany
Research Site
Mönchengladbach, 41063, Germany
Research Site
München, 81377, Germany
Research Site
München-Pasing, 81241, Germany
Research Site
Neu-Isenburg, 63263, Germany
Research Site
Wiesbaden, 65183, Germany
Research Site
Witten, 58452, Germany
Research Site
Zossen, 15806, Germany
Research Site
Hong Kong, 999077, Hong Kong
Research Site
Pok Fu Lam, 999077, Hong Kong
Research Site
Shatin, 0000, Hong Kong
Research Site
Ballinasloe, H53 T971, Ireland
Research Site
Cork, T12 DFK4, Ireland
Research Site
Dublin, D15 X40D, Ireland
Research Site
Moneymore, A92 VW28, Ireland
Research Site
Bari, 70124, Italy
Research Site
Bergamo, 24127, Italy
Research Site
Brescia, 25123, Italy
Research Site
Cagliari, 09122, Italy
Research Site
Catanzaro, 88100, Italy
Research Site
Genoa, 16132, Italy
Research Site
Milan, 20122, Italy
Research Site
Modena, 41124, Italy
Research Site
Montebelluna, 31044, Italy
Research Site
Naples, 80131, Italy
Research Site
Roma, 00161, Italy
Research Site
Roma, 00168, Italy
Research Site
Rozzano, 20089, Italy
Research Site
Verona, 37124, Italy
Research Site
Lørenskog, N-1478, Norway
Research Site
Alcorcón, 28922, Spain
Research Site
Alzira (Valencia), 46600, Spain
Research Site
Badalona, 08916, Spain
Research Site
Barakaldo, 48902, Spain
Research Site
Barcelona, 08025, Spain
Research Site
Barcelona, 08035, Spain
Research Site
Burgos, 09006, Spain
Research Site
Cáceres, 10003, Spain
Research Site
Granada, 18014, Spain
Research Site
Jerez de la Frontera, 11407, Spain
Research Site
Lugo, 27003, Spain
Research Site
Madrid, 28034, Spain
Research Site
Madrid, 28041, Spain
Research Site
Madrid, 28050, Spain
Research Site
Marbella, 29600, Spain
Research Site
Marbella, 29603, Spain
Research Site
Málaga, 29010, Spain
Research Site
Mérida, 06800, Spain
Research Site
Palma de Mallorca, 7120, Spain
Research Site
Santander, 39008, Spain
Research Site
Aarau, 5001, Switzerland
Research Site
Basel, 4031, Switzerland
Research Site
Lausanne, 1011, Switzerland
Research Site
Sankt Gallen, 9007, Switzerland
Research Site
Sion, 1951, Switzerland
Research Site
Belfast, BT9 7AB, United Kingdom
Research Site
Birmingham, B9 5SS, United Kingdom
Research Site
Bradford, BD9 6RJ, United Kingdom
Research Site
Bristol, BS10 5NB, United Kingdom
Research Site
Chorley, PR7 1PP, United Kingdom
Research Site
Leeds, LS9 7TF, United Kingdom
Research Site
Liverpool, L7 8XP, United Kingdom
Research Site
Nottingham, NG7 2UH, United Kingdom
Research Site
Portsmouth, PO6 3LY, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
AstraZeneca Clinical Study Information Center
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Benralizumab and placebo will be supplied in identical Accessorised pre-filled syringe (APFS). Medium and high dose ICS-LABA will be supplied in identical inhalers, as appropriate for US and ex-US markets, and the maximum daily dose is the same for the 2 Investigational products (IPs) (2 doses/day). Participants are not aware of the dose levels to which they are assigned. The Interactive Response Technology / Randomisation and Trial Supply Management (IRT/RTSM) will provide to the investigator(s) or pharmacist(s) the kit identification number to be allocated to the participant at the dispensing visit. Routines for this will be described in the IRT/RTSM user manual that will be provided to each centre.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 20, 2024
First Posted
December 27, 2024
Study Start
March 28, 2025
Primary Completion (Estimated)
November 3, 2027
Study Completion (Estimated)
November 3, 2027
Last Updated
March 19, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.