Benralizumab for Asthma

(AERFLO Trial)

Not currently recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Dr. Grace Parraga

Must be taking: Inhaled corticosteroids, Long-acting β2-agonists

Must not be taking: Immunosuppressives, Nonselective β-blockers

Disqualifiers: Pulmonary disease, Cardiovascular disorders, others

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

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 7

Duration: 16 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests benralizumab, a drug designed to help people with severe, hard-to-control asthma. Benralizumab reduces eosinophils, a type of white blood cell that can inflame the airways in some asthma patients. The study will determine if this treatment improves lung function, reduces breathing problems, and enhances participants' quality of life. Individuals with a history of poorly controlled asthma who have not smoked for at least a year might be suitable for this trial. As an unphased trial, this study offers participants the chance to contribute to valuable research that could lead to better asthma treatments.

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 chronic maintenance prednisone for asthma is allowed, and you must have been on certain asthma medications for at least 12 months before joining. It's best to discuss your specific medications with the trial team.

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 one study, about 76% of people taking benralizumab and 80% of those taking a placebo (a fake treatment) experienced side effects. This indicates that benralizumab does not cause more side effects than no treatment at all.

Another study examined the long-term use of benralizumab and found that many patients experienced fewer asthma attacks, with no new safety issues emerging. This suggests the treatment is safe for ongoing use.

Real-world data also supports its safety. In a group of 632 people, many did not report serious problems with the drug, reinforcing the evidence that benralizumab is safe for people with severe, uncontrolled asthma.

Overall, current studies suggest that benralizumab is safe and well-tolerated. However, as with any treatment, individuals might react differently. Always consult a healthcare provider before deciding to join a clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Benralizumab is unique because it targets and depletes eosinophils, which are inflammatory cells that play a significant role in asthma, by binding to the interleukin-5 receptor. This mechanism is different from many standard asthma treatments, like inhaled corticosteroids and bronchodilators, which focus on reducing inflammation and opening airways without specifically targeting eosinophils. Researchers are excited about benralizumab because it offers a more tailored approach, potentially leading to better control of symptoms for patients with eosinophilic asthma. Additionally, its administration as a subcutaneous injection could make it a convenient option for those who prefer less frequent dosing than daily inhalers.

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

Research has shown that benralizumab, the treatment under study in this trial, can improve symptoms in people with severe eosinophilic asthma, which involves a type of white blood cell. Studies have found that benralizumab reduces asthma flare-ups by 51% when used with regular treatment. Additionally, nearly 60% of patients experienced no flare-ups during long-term use. By targeting and reducing these specific white blood cells, benralizumab improves lung function and controls asthma symptoms. This evidence suggests that benralizumab could be a promising option for people with severe, hard-to-control asthma. ^{1 2 3 4 6}

Who Is on the Research Team?

Grace E Parraga, PhD

Principal Investigator

Robarts Research Institute, The University of Western Ontario

Are You a Good Fit for This Trial?

Adults aged 18-70 with severe, poorly controlled eosinophilic asthma who have been on high-dose inhalers and additional medications. They must not smoke, be able to use effective birth control if applicable, and have a history of responding to bronchodilators or positive methacholine tests. Excluded are those with other significant health issues, metal implants incompatible with MRI, recent drug abuse, or certain medication use.

Inclusion Criteria

I am using a reliable method of birth control or am not sexually active.

I have shown significant improvement in lung function tests or had a positive asthma test in the last 2 years.

I have been using high-dose asthma inhalers and long-term breath aids for over a year.

Exclusion Criteria

You have struggled with alcohol or drug abuse in the past year.

I am a new mother, within 8 weeks post-partum or currently breastfeeding.

You have had a severe allergic reaction to any biologic therapy in the past.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive benralizumab 30mg subcutaneous injection on study days 0, 28, and 56, with MRI and other assessments

16 weeks

5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments on Day 112

4 weeks

1 visit (in-person)

Open-label extension (optional)

Participants may opt into continuation of benralizumab treatment every 8 weeks

Long-term

What Are the Treatments Tested in This Trial?

Interventions

• Benralizumab

Trial Overview

The trial is testing benralizumab's effect on lung function in severe asthma patients by using Hyperpolarized 129-Xenon MRI imaging. Participants will receive three doses of benralizumab four weeks apart while undergoing MRIs, breathing tests, blood/sputum analysis and quality of life questionnaires before and after treatment.

How Is the Trial Designed?

Group I: Treatment Experimental Treatment 2 Interventions

Benralizumab 30mg subcutaneous injection on study days 0, 28 and 56 and 1.0 L 129-Xenon/4-Helium mixture, twice per visit, on days 0, 14, 28 and 112.

Benralizumab is already approved in European Union, United States, Canada, Japan for the following indications:

Approved in European Union as Fasenra for:

• Severe eosinophilic asthma

Approved in United States as Fasenra for:

• Severe asthma with an eosinophilic phenotype

Approved in Canada as Fasenra for:

• Severe eosinophilic asthma

Approved in Japan as Fasenra for:

• Severe eosinophilic asthma

Who Is Running the Clinical Trial?

Dr. Grace Parraga

Lead Sponsor

Trials

6

Recruited

490+

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

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11844207/

Benralizumab Outcomes in Patients with Severe Eosinophilic ...

Overall, the percentage of patients with asthma control (ACT>19) increased during benralizumab treatment, ranging from 50% to 68% at every ...

2.

fasenrahcp.com

fasenrahcp.com/long-term-data

Long-Term Data | FASENRA® (benralizumab) | For HCPs

Of the patients receiving FASENRA Q8W, 59% had zero exacerbations across the extension study period (n=110; over 304 total follow-up years). The primary ...

3.

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 ...

4.

fasenrastudies.com

fasenrastudies.com/

FASENRA® (benralizumab) Subcutaneous Injection Studies ...

​51% reduction in the annual asthma exacerbation rate was observed in patients treated with FASENRA + standard of care (SOC) (n=267) vs placebo + SOC (n=267) ( ...

5.

sciencedirect.com

sciencedirect.com/science/article/pii/S0954611124000854

Benralizumab efficacy and safety in severe asthma

The frequency of adverse events was similar for benralizumab (76%) and placebo (80%) in the overall population. Conclusions. MIRACLE data reinforces the ...

6.

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 ...