Eosinophilic AsthmaPhase 3BRISOTENCT06750289
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
A Phase 3 study testing ICS-LABA and benralizumab in people with Eosinophilic Asthma, run by AstraZeneca at 86 sites in 13 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 75 years
- Conditions the study is for
- Eosinophilic Asthma
- What is being tested?
- ICS-LABA and benralizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 130 participants
- Where
- 86 sitesin 13 countries
- Study dates
- 28 Mar 2025to 21 Sep 2026
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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.
Trial locations and contacts
86 sites in 13 countries.
86 sites in 13 countries
United States20 sites
Research Site
Ann Arbor, Michigan, 48109
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Cape Coral, Florida, 33990
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DuBois, Pennsylvania, 15801
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Greenville, South Carolina, 29607
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Henderson, Nevada, 89052
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Inglewood, California, 90301
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Lauderdale Lakes, Florida, 33313
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Leesburg, Florida, 34748
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Miami, Florida, 33175
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New Hyde Park, New York, 11042
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Newport Beach, California, 92663
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Northfield, New Jersey, 08225
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Pasadena, California, 91101
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San Antonio, Texas, 78251
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Sun City, Arizona, 85351
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Tampa, Florida, 33607
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The Bronx, New York, 10459
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Tucson, Arizona, 85704
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Warwick, Rhode Island, 02886
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Winter Park, Florida, 32789
China18 sites
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Beijing, 100044
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Beijing, 102218
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Changsha, 410004
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Chongqing, 400042
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Fuzhou, 350008
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Guangzhou, 510120
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Guangzhou, 510180
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Hangzhou, 310014
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Hefei, 230061
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Huizhou, 516002
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Jinan, 250021
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Qinhuangdao
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Shanghai, 200080
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Shanghai, 200433
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Wuhan, 430030
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Xuzhou, 221000
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Yinchuan, 750004
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Zhengzhou, 450000
Spain11 sites
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Alcorcón, 28922
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Badalona, 08916
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Barakaldo, 48902
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Jerez de la Frontera, 11407
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Lugo, 27003
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Madrid, 28034
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Málaga, 29010
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Marbella, 29600
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Marbella, 29603
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Palma de Mallorca, 7120
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Santander, 39008
Italy8 sites
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Bergamo, 24127
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Genoa, 16132
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Milan, 20122
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Naples, 80131
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Roma, 00161
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Roma, 00168
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Rozzano, 20089
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Verona, 37124
Germany6 sites
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Berlin, 10367
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Berlin, 10717
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Cottbus, 03050
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Geesthacht, 21502
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Lübeck, 23552
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Wiesbaden, 65183
Bulgaria5 sites
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Plovdiv, 4002
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Rousse, 7002
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Sofia, 1142
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Sofia, 1431
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Stara Zagora, 6000
Canada4 sites
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Ajax, Ontario, L1S 2J5
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Kamloops, British Columbia, V2C 5T1
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Toronto, Ontario, M5T 3A9
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Windsor, Ontario, N8X 1T3
France4 sites
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Créteil, 94010
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Montpellier, 34295
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Toulouse, 31059
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Villeurbanne, 69100
United Kingdom4 sites
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Birmingham, B9 5SS
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Bradford, BD9 6RJ
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Bristol, BS10 5NB
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Leeds, LS9 7TF
Ireland3 sites
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Cork, T12 DFK4
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Dublin, D15 X40D
Research Site
Moneymore, A92 VW28
About this study
Official title: 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.
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.
Read the detailed description
This is a randomized, double-blind, active-controlled, parallel group global study designed to investigate the efficacy and safety of adding fixed-dose benralizumab (30 mg), administered subcutaneously (SC) every 4 weeks for the first 3 doses and then every 8 weeks for participants with a history of eosinophilic asthma, who remain uncontrolled on medium-dose Inhaled corticosteroid-Long-acting β2-agonists (ICS-LABA) with or without other asthma controller(s) (with the exception of oral corticosteroids), compared to the conventional treatment step of escalation of inhaled therapy to high-dose ICS-LABA plus placebo (benralizumab).
- Conditions
- Eosinophilic Asthma
- Being tested
- ICS-LABA, benralizumab, Placebo for Benralizumab
- Keywords
- Eosinophilic Asthma;, Benralizumab,, FASENRA,, Medium-Dose Inhaled Corticosteroid,, Long-acting β2-Agonist
- Medical subject headings
- Pulmonary Eosinophilia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICS-LABACombination product
ICS-LABA inhalation
benralizumabCombination product
Benralizumab. SC injection.
Placebo for BenralizumabCombination product
Placebo for Benralizumab (aka, "placebo"). SC injection.
| Study group | Role | What they receive |
|---|---|---|
| Medium-dose ICS-LABA + benralizumab | Active comparator | 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. Receives: Combination Product: ICS-LABA; Combination Product: benralizumab |
| High-dose ICS-LABA + placebo | Active comparator | 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. Receives: Combination Product: ICS-LABA; Combination Product: Placebo for Benralizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Annualized asthma exacerbation rate
To assess asthma exacerbation rate.
Measured: Baseline through Week 48
Secondary outcomes (7)
Change in Saint George's Respiratory Questionnaire (SGRQ) total score
The SGRQ is a 50-item ePRO instrument developed to measure the health status of participants with airway obstruction disease. The questionnaire is divided into 2 parts: Part 1 consists of 8 items that pertain to the severity of respiratory symptoms in the preceding 4 weeks, and Part 2 consists of 42 items related to the daily activity and psychosocial impacts of the individual's respiratory condition. The SGRQ yields a total score and 3 component scores (symptoms, activity, and impacts). The total score indicates the impact of disease on overall health status. This total score ranges from 0 to 100 with 0 indicating the best possible health status and 100 representing the worst possible health status
Measured: Baseline through Week 48
Change in pre-bronchodilator FEV1
Lung function is assessed by FEV1 which was measured by spirometry. Spirometry will be performed by the Investigator or authorized delegate according to American Thoracic Society /European Respiratory Society guidelines.
Measured: Baseline through Week 48
Change in Asthma control questionnaire (ACQ) scale score.
The ACQ-6 is a shortened version of the full 7-item ACQ questionnaire, which assesses asthma symptoms (nighttime awakening, symptoms on awakening, activity limitation, shortness of breath, wheezing, SABA use) but omits the FEV1 measurement from the original ACQ-7 assessment. Participants are asked to recall how their asthma has been during the previous week by responding to 6 symptom questions. Questions are weighted equally and scored from 0 (totally controlled) to 6 (severely uncontrolled). The total ACQ-6 score is the mean of the responses.
The effect of benralizumab will be evaluated with the change from baseline in ACQ-6 to End of treatment (week 48) and over the treatment period.
Measured: Baseline through Week 48.
Time to first asthma exacerbation
Time to the first occurrence of asthma exacerbation post randomisation.
Measured: Baseline through Week 48.
Annualized asthma exacerbation rate associated with an emergency/urgent care visit or a hospitalization
The annualized exacerbation rate is based on unadjudicated exacerbation reported by the investigator that are associated with an emergency room/urgent care visit or a hospitalization adjusted by the time of follow-up.
Measured: Baseline through Week 48.
Number and proportion of participants that meet each component of a 4-component clinical remission composite
- Number and proportion of participants that meet each component of a 4-component clinical remission composite (no exacerbations; no mOCS use; ACQ-6 < 1.5); and stable FEV1 (defined as change from baseline in FEV1 > -100 mL) at Week 24 and EOT.
- Number and proportion of participants that meet 0, 1, 2, 3 and all 4 components of the composite remission endpoint at Week 24 and EOT.
Measured: Week 24 and Week 48.
Safety Adverse Event (AEs), Serious Adverse Event (SAEs), Adverse event leading to treatment discontinuation (DAEs.)
Measured: Baseline through Week 48.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2024
- Study start28 Mar 2025
- Primary completion21 Sep 2026
- Study completion21 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eosinophilic AsthmaStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomised 1:1 to one of the following arms: * Medium-dose ICS-LABA + benralizumab * High-dose ICS-LABA + placebo (benralizumab)
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06750289
- Sponsor's protocol ID
- D3250C00101
- Acronym
- BRISOTE
- Status last verified
- Oct 2026
- First submitted
- 20 Nov 2024
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.