Benralizumab for Asthma

(BRISOTE Trial)

Recruiting at 22 trial locations

Overseen By AstraZeneca Clinical Study Information Center

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: AstraZeneca

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Research Team

John Zwetchkenbaum, MD

Principal Investigator

Aapri Clinical Research Institute

Juan Rodriguez, MD

Principal Investigator

Sun City Clinical Research

Erika Gonzalez, MD

Principal Investigator

South Texas Allergy & Asthma Medical Professionals (STAAMP)

Dena Petersen, MD

Principal Investigator

Noble Clinical Research - Elite Clinical Network

Sady Alpizar, MD

Principal Investigator

Clinical Research Trials of Florida, Inc.

Mila Leong, MD

Principal Investigator

Pediatric Pulmonary & Asthma Associates of South Jersey, LLC

Alfonso Gonzalez-Rodriguez, MD

Principal Investigator

Florida Premier Research Institute - Clay Street

Neil Kao, MD

Principal Investigator

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

Charles Lunn, MD

Principal Investigator

Lynn Health Science Institute East

Mina Makaryus, MD

Principal Investigator

Northwell Health - Centers for Advanced Medicine

Tzu-Jen Tzao, MD

Principal Investigator

Pasadena Clinical Trials

Patel Paryus, MD

Principal Investigator

Prime Healthcare - Inglewood

Marvin Heuer, MD

Principal Investigator

Heuer M.D. Research, Inc.

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

Jeremy Cole, MD

Principal Investigator

IPS Research Company

Shahrukh Kureishy, MD

Principal Investigator

Metroplex Pulmonary and Sleep Center

Njira Lugogo, MD

Principal Investigator

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

Samuel DeLeon, MD

Principal Investigator

Urban Health Plan

Eligibility Criteria

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.

Treatment Details

Interventions

• Benralizumab (Monoclonal Antibodies)

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.

Participant Groups

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