Benralizumab for Asthma

MS
SG
Overseen BySamantha Gongora
Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: Endeavor Health
Must be taking: Benralizumab, ICS inhaler
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how well benralizumab, a medication for severe eosinophilic asthma, controls asthma symptoms. Researchers will assess its effectiveness by monitoring inhaler use with special electronic devices. Participants will switch to a study-provided rescue inhaler and document their medication use with photos. Ideal candidates have experienced severe asthma for at least a year, currently use benralizumab, and are willing to use the study's inhalers. As a Phase 4 trial, this study involves an FDA-approved treatment and aims to understand how benralizumab benefits more patients.

What is the safety track record for benralizumab and budesonide-albuterol?

Research has shown that benralizumab is generally safe and well-tolerated for people with severe asthma. Several studies found no new safety concerns, and patients from various backgrounds received it well. One study reported that 12.7% of patients experienced mild side effects, while serious side effects were rare, occurring in about 13% of cases. Serious infections were even less common, occurring in 3.8% of cases.

Benralizumab also appears to help reduce asthma attacks. Some studies reported a significant decrease in the number of asthma attacks, which is promising for its long-term use.

This treatment already has approval for other conditions, providing some reassurance about its safety. Overall, based on existing data, benralizumab appears to be a safe option for managing severe asthma.12345

Why are researchers enthusiastic about this study treatment?

Unlike the standard treatments for asthma, which typically involve inhaled corticosteroids and bronchodilators, benralizumab offers a unique approach by specifically targeting and depleting eosinophils, a type of white blood cell involved in inflammation. This mechanism makes benralizumab particularly promising for patients with eosinophilic asthma, as it directly reduces the source of inflammation rather than just addressing symptoms. Researchers are excited about benralizumab because it can potentially lead to more effective and long-term control of asthma symptoms, reducing the need for frequent use of relief inhalers.

What is the effectiveness track record for benralizumab in maintaining asthma control?

Studies have shown that benralizumab can greatly reduce asthma flare-ups. Specifically, patients experienced a 49% to 60% reduction in flare-up rates after 12 weeks of treatment. Benralizumab targets and reduces eosinophils, a type of white blood cell that can worsen asthma symptoms. This treatment is already approved for severe asthma and has proven effective in managing the condition. Additionally, research has shown that the budesonide-albuterol inhaler, called AirSupra, lowers the risk of severe asthma attacks by 27%. In this trial, participants will receive an open-label combination of benralizumab and AirSupra, which may help maintain better asthma control.678910

Who Is on the Research Team?

GM

Giselle Mosnaim, MD, MS

Principal Investigator

Endeavor Health

Are You a Good Fit for This Trial?

This trial is for adults (18+) with severe eosinophilic asthma who have been on benralizumab for at least 6 months and use a daily inhaler. Participants must not be current smokers, must have stable health, and cannot join if they recently had a serious asthma attack or are in another asthma study.

Inclusion Criteria

I have taken benralizumab for severe asthma for at least 6 months and had 4 or more doses.
I am able to understand and sign the consent form for this study.
I have used a daily inhaler with steroids at the same dose for at least 3 months.
See 3 more

Exclusion Criteria

I have had bad reactions to budesonide-albuterol before.
I have not used any asthma biologic except benralizumab in the past 5 months.
Current smoker including tobacco, vaping, and marijuana; former smokers must have stopped 6 months or more prior to Visit 1
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks
1 visit (in-person)

Treatment

Participants receive benralizumab every 8 weeks and use electronic medication monitors to track inhaler usage

24 weeks
4 visits (1 in-person, 3 virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Benralizumab
  • Budesonide-albuterol

Trial Overview

The study observes how well benralizumab helps control severe eosinophilic asthma over time. It also tracks the use of regular maintenance inhalers and an albuterol-budesonide rescue inhaler using electronic monitors.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Open-Label benralizumab + budesonide-albuterolExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Endeavor Health

Lead Sponsor

Trials
135
Recruited
742,000+

AstraZeneca

Industry 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

Citations

Mechanism of Disease and Mechanism of Action

FASENRA is not indicated for the relief of acute bronchospasm or status asthmaticus … linical Trial Data Overview: Efficacy and Safety Data

Benralizumab: From the Basic Mechanism of Action to ... - PMC

When compared with placebo, after 12 weeks of treatment, benralizumab induced significant decreases of 49% and 60% in the rates of asthma exacerbations and ...

Benralizumab for the Prevention of COPD Exacerbations

By week 4, and through to week 56, benralizumab resulted in substantial depletion of blood eosinophils, and substantial depletion of sputum ...

BRISOTE

This study evaluates the efficacy and safety of benralizumab as an add-on therapy in uncontrolled eosinophilic asthma participants treated with medium-dose ...

Anti Benralizumab Antibody, clone AbD59973

Benralizumab is indicated as a maintenance treatment for severe asthma ... Data for benralizumab are shown as the mean of three measurements. Anti Benralizumab ...

Real-World Safety and Effectiveness of Benralizumab in ...

ADRs were reported in 12.7% and serious AEs in 13.0% of patients. Serious infections occurred in 3.8%, serious hypersensitivity in 0.3%, and ...

Benralizumab efficacy and safety in severe asthma

5 Conclusions. Benralizumab treatment significantly reduced AAER, and improved lung function, asthma symptoms, symptom control, and HRQoL in patients from Asia ...

Benralizumab Effectiveness in Severe Asthma Is ...

Benralizumab led to an 81% reduction in exacerbation rate, with 48% of patients with previous exacerbations experiencing none after 48 weeks.

Safety and effectiveness of benralizumab in Indian patients ...

The results indicate that benralizumab is safe and well-tolerated in Indian patients, with no new safety signals. In our study, the median asthma duration was ...

Severe asthma: safety of benralizumab in adolescents

Benralizumab was well tolerated – no serious side effects occurred · When administered every eight weeks, it reduced the number of asthma attacks ...