Benralizumab for Asthma

(BRISOTE Trial)

Recruiting at 149 trial locations

Overseen By AstraZeneca Clinical Study Information Center

Age: Any Age

Sex: Any

Trial Phase: Phase 3

Sponsor: AstraZeneca

Must be taking: ICS-LABA

Must not be taking: Systemic corticosteroids

Disqualifiers: Pulmonary disease, Chronic infections, Smoking, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 7

Duration: 48 weeks

400 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a drug called benralizumab (an injectable medication) to determine if it improves symptoms in people with uncontrolled eosinophilic asthma when added to their current treatment. Eosinophilic asthma involves high levels of eosinophils (a type of white blood cell) and often results in more severe symptoms. Participants will either receive benralizumab alongside their usual medium-dose asthma treatment or continue with a higher dose of their current inhaler. Individuals who have had asthma for at least a year, experience frequent asthma attacks, and do not find relief with their current medium-dose inhaler might be suitable for this trial. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking asthma treatment.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it mentions that participants should have been on medium-dose ICS-LABA for at least 3 months before starting the trial, so you may need to continue those medications.

Is there any evidence suggesting that benralizumab is likely to be safe for humans?

Research has shown that benralizumab is generally well-tolerated by people with severe asthma. In earlier studies, many participants experienced only mild side effects. For instance, about 21% reported minor issues such as the common cold, worsening asthma, bronchitis, and headaches. Serious side effects were rare and occurred at similar rates in those not taking benralizumab.

The FDA has already approved benralizumab for treating certain types of asthma, indicating it has passed important safety checks for that condition. This approval provides some confidence in its safety for other related asthma conditions. Consulting a healthcare provider is always advisable to understand the potential risks and benefits. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for asthma?

Unlike standard asthma treatments that often involve corticosteroids and long-acting beta agonists (ICS-LABA), benralizumab offers a fresh approach by targeting the IL-5 receptor on eosinophils, a type of white blood cell involved in inflammation. This mechanism helps reduce inflammation with potentially fewer side effects than traditional steroids. Researchers are excited about benralizumab because it is administered as an injection every 8 weeks, which could improve adherence and convenience for patients compared to daily medications. Additionally, this treatment may offer more targeted relief for patients with severe eosinophilic asthma, providing a promising option for those who don't respond well to conventional therapies.

What evidence suggests that benralizumab might be an effective treatment for asthma?

Research has shown that benralizumab effectively treats hard-to-control eosinophilic asthma. Studies have found it can improve breathing and lower eosinophil levels, key indicators of asthma. Notably, benralizumab reduced asthma attacks by over 90% annually. It also helps patients rely less on oral steroids. In this trial, participants will receive either a medium-dose ICS-LABA with benralizumab or a high-dose ICS-LABA with a placebo, making benralizumab a promising additional treatment for those who struggle to manage their asthma with regular inhalers. ^{6 7 8 9 10}

Who Is on the Research Team?

Alfonso Gonzalez-Rodriguez, MD

Principal Investigator

Florida Premier Research Institute - Clay Street

Mila Leong, MD

Principal Investigator

Pediatric Pulmonary & Asthma Associates of South Jersey, LLC

Erika Gonzalez, MD

Principal Investigator

South Texas Allergy & Asthma Medical Professionals (STAAMP)

Dena Petersen, MD

Principal Investigator

Noble Clinical Research - Elite Clinical Network

John Zwetchkenbaum, MD

Principal Investigator

Aapri Clinical Research Institute

Sady Alpizar, MD

Principal Investigator

Clinical Research Trials of Florida, Inc.

Marvin Heuer, MD

Principal Investigator

Heuer M.D. Research, Inc.

Tzu-Jen Tzao, MD

Principal Investigator

Pasadena Clinical Trials

Jeremy Cole, MD

Principal Investigator

IPS Research Company

Neil Kao, MD

Principal Investigator

Allergic Disease & Asthma Center, P.A. (ADAC) - Butler Road Office

Shahrukh Kureishy, MD

Principal Investigator

Metroplex Pulmonary and Sleep Center

Juan Rodriguez, MD

Principal Investigator

Sun City Clinical Research

Samuel DeLeon, MD

Principal Investigator

Urban Health Plan

Njira Lugogo, MD

Principal Investigator

University of Michigan Health System - A. Alfred Taubman Health Care Center - Pulmonary Clinic

Patel Paryus, MD

Principal Investigator

Prime Healthcare - Inglewood

Charles Lunn, MD

Principal Investigator

Lynn Health Science Institute East

Mina Makaryus, MD

Principal Investigator

Northwell Health - Centers for Advanced Medicine

Sandeep Bansal, MD

Principal Investigator

Clinical Research Associates of Central PA

Muhammad Salim, MD

Principal Investigator

Chandler Clinical Trials

Jose Diaz, MD

Principal Investigator

Flourish Research - Leesburg

Ryan Klein, MD

Principal Investigator

NewportNativeMD, Inc.

Rohit Katial, MD

Principal Investigator

National Jewish Health

Vikas Sayal, MD

Principal Investigator

Henderson Clinical Trials, LLC

Are You a Good Fit for This Trial?

This trial is for people with a type of asthma called eosinophilic asthma that's not well-controlled by their current medium-dose inhaler treatment. Participants should be adults who can safely receive injections under the skin and have not responded well to standard therapies.

Inclusion Criteria

I've been treated with specific asthma medication for at least 3 months.

Written informed consent

I have asthma treated with a medium or higher dose of inhalers for over a year.

Exclusion Criteria

I have a lung condition other than asthma, or a disease linked to high eosinophil counts.

Any unstable disorder that in the opinion of the investigator could affect the study according to the study protocol

I haven't needed steroids for asthma or antibiotics for infections in the last 30 days.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive benralizumab 30 mg SC or placebo as an add-on therapy every 4 weeks for the first 3 doses, then every 8 weeks, for a total of up to 7 injections

48 weeks

7 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Benralizumab

Trial Overview The study is testing if adding Benralizumab, an injectable medication, to current asthma treatment is better than just increasing the dose of inhaled steroids. Some participants will get Benralizumab while others will get a placebo as part of the research.

How Is the Trial Designed?

Group I: Medium-dose ICS-LABA + benralizumab Active Control 2 Interventions

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.

Group II: High-dose ICS-LABA + placebo Active Control 2 Interventions

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.

Who Is Running the Clinical Trial?

AstraZeneca

Lead Sponsor

Trials

4,491

Recruited

290,540,000+

Sir Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Dr. Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Published Research Related to This Trial

Benralizumab is a monoclonal antibody that targets the interleukin-5 receptor, effectively inhibiting eosinophil and basophil proliferation, which is crucial for managing severe asthma.

Clinical trials have shown that benralizumab significantly reduces asthma exacerbation rates, improves lung function (measured by FEV1), and enhances quality of life for patients with high eosinophil counts, while being well tolerated.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Benralizumab for the treatment of asthma. Matera, MG., Rogliani, P., Calzetta, L., et al.[2018]

Benralizumab significantly reduces asthma exacerbations and improves lung function in patients with severe, uncontrolled asthma, with a notable reduction in annual exacerbation rates (AER) observed in patients with higher baseline eosinophil counts and more frequent exacerbation histories.

In a pooled analysis of 2295 patients from two phase 3 studies, those receiving benralizumab every 4 weeks showed a 37% reduction in AER compared to placebo, while those receiving it every 8 weeks had a 36% reduction, indicating that the treatment is effective across different eosinophil thresholds.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictors of enhanced response with benralizumab for patients with severe asthma: pooled analysis of the SIROCCO and CALIMA studies. FitzGerald, JM., Bleecker, ER., Menzies-Gow, A., et al.[2022]

In a study of 429 patients with severe eosinophilic asthma treated with benralizumab, asthma exacerbation rates significantly decreased by 52% to 64% after treatment, demonstrating its effectiveness across various eosinophil levels.

Patients switching from other biologics to benralizumab also experienced substantial reductions in exacerbation rates, with 39% to 49% of patients having no exacerbations during the first 24 months of follow-up, indicating long-term clinical benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-World Effectiveness Study of Benralizumab for Severe Eosinophilic Asthma: ZEPHYR 2. Carstens, D., Maselli, DJ., Mu, F., et al.[2023]

In a real-world study of 205 patients with severe eosinophilic asthma treated with benralizumab for an average of 9.8 months, there was a dramatic reduction in exacerbations, with 81% of patients becoming exacerbation-free and a 93.3% decrease in the annualized exacerbation rate.

Benralizumab treatment also led to significant reductions in oral corticosteroid use, with 43.2% of patients able to stop OCS therapy and an overall dose reduction of 56%, indicating its effectiveness in managing severe asthma symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

ChAracterization of ItaliaN severe uncontrolled Asthmatic patieNts Key features when receiving Benralizumab in a real-life setting: the observational rEtrospective ANANKE study. Menzella, F., Bargagli, E., Aliani, M., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11559237/

Benralizumab: Effectiveness in Patients with Uncontrolled ... Benralizumab improved respiratory function as well as key biomarkers such as eosinophil count, exhaled nitric oxide fraction (FeNO), which ...

2. respiratory-research.biomedcentral.com respiratory-research.biomedcentral.com/articles/10.1186/s12931-023-02439-w

Long-term effectiveness of benralizumab in severe ... Benralizumab treatment was shown to induce over 90% reduction in annualized exacerbation rate (AER) (both severe and any kind of exacerbations), ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0954611123001737

Real-world effectiveness of benralizumab in US ... Benralizumab was associated with improved outcomes in severe eosinophilic asthma. •. Exacerbation reduction was observed in patients switching from other ...

4. nature.com nature.com/articles/s41598-025-07275-0

Factors influencing the real-world effectiveness of ... The ZONDA trial, a phase III study, demonstrated that patients treated with benralizumab achieved a 75% reduction in OCS dose compared to a 25% ...

5. mdpi.com mdpi.com/2077-0383/13/10/3013

Unlocking the Long-Term Effectiveness of Benralizumab in ... Results: At 36 months, benralizumab reduced the exacerbation rate by 89% and increased the forced expiratory volume in 1 second (FEV1) (+440 mL at 36 months, p ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12584834/

Long-term effectiveness and safety of benralizumab in EGPA From a safety perspective, benralizumab was well tolerated, with only 21.2% of patients experiencing mild adverse events and no reports of ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S0954611124000854

Benralizumab efficacy and safety in severe asthma Benralizumab treatment significantly reduced AAER, and improved lung function, asthma symptoms, symptom control, and HRQoL in patients from Asia with SEA. These ...

8. respiratory-research.biomedcentral.com respiratory-research.biomedcentral.com/articles/10.1186/s12931-023-02539-7

Achieving clinical outcomes with benralizumab in severe ... Almost half (43.7%) of the OP on benralizumab met all four criteria for clinical remission. Patients with concomitant CRSwNP obtained similar or ...

9. fasenrahcp.com fasenrahcp.com/safety

Safety Profile | FASENRA® (benralizumab) | For HCPs The most common AEs (≥5% in the FASENRA Q8W arm) were nasopharyngitis, worsening asthma, bronchitis, and headache · Event rates for SAEs were similar across all ...

10. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10807277/

Real-World Safety and Effectiveness of Benralizumab in ... In total, 632 patients were evaluated for safety and 274 for effectiveness; 139 patients were included in the severe uncontrolled asthma ...