What side effects are associated with this type of intervention?

Common treatments for severe asthma, including monoclonal antibodies like Benralizumab, can have several side effects. Benralizumab, which targets IL-5 receptors to deplete eosinophils, may cause headaches, pharyngitis, and injection site reactions. Other biologics, such as Tezepelumab (anti-TSLP), can lead to serious adverse effects like pneumonia, stroke, and Guillain-Barré syndrome, though these are rare. Combination therapies involving ICS, LABA, and LAMA can result in dry mouth, potential cardiac events, and increased risk of infections. Overall, while these treatments are effective in reducing exacerbations and improving lung function, they come with a range of potential side effects that should be monitored.

What prior FDA approvals exist?

The FDA has approved several biologic agents for the treatment of asthma, particularly targeting severe eosinophilic asthma. Benralizumab, an Anti-IL-5 Receptor Monoclonal Antibody, depletes eosinophils and is one such treatment. Other similar biologics include Mepolizumab and Reslizumab, both of which target IL-5 to reduce eosinophil levels. Dupilumab, an Anti-IL-4 Receptor Alpha Monoclonal Antibody, inhibits IL-4 and IL-13 signaling, and Tezepelumab targets thymic stromal lymphopoietin (TSLP) to reduce inflammation. These treatments are designed to manage severe asthma by targeting specific pathways involved in the inflammatory process.

What other types of research exist?

Promising novel alternatives to Benralizumab for asthma patients include Dupilumab (an IL-4 and IL-13 inhibitor) and Tezepelumab (an anti-TSLP monoclonal antibody). Both have shown significant efficacy in reducing asthma exacerbations and improving lung function in clinical trials.

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Monoclonal Antibodies

Benralizumab for Severe Asthma (BURAN Trial)

Phase 4

Recruiting

Research Sponsored by AstraZeneca

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Have you been diagnosed with Asthma?

Have had at least two exacerbations within the last 12 months?

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from screening to follow-up (up to 1.4 years)

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial will test benralizumab, a medication that reduces inflammation in the airways, on adults with severe eosinophilic asthma not well-controlled by standard treatments. The medication works by lowering the number of specific cells that cause breathing problems. Benralizumab helps improve lung function for patients with severe, uncontrolled asthma with eosinophilic inflammation.

Who is the study for?

This trial is for people with severe eosinophilic asthma who've had at least two flare-ups in the past year. They should be on a stable asthma treatment and able to stop their maintenance medication for 12-24 hours before certain visits. It's not open to those with significant other diseases, a current or past cancer diagnosis, or a history of specific lung procedures.

What is being tested?

The BURAN study is testing how benralizumab affects airway dynamics in patients with severe eosinophilic asthma. Researchers will use advanced imaging (Functional Respiratory Imaging) and CT scans to measure changes in lung structure and function.

What are the potential side effects?

Benralizumab may cause side effects such as headache, sore throat, fever, fatigue, allergic reactions including anaphylaxis, and injection site reactions like pain or swelling.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with asthma.

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I have had two or more flare-ups of my condition in the past year.

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My asthma treatment has not changed recently.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from screening to follow-up (up to 1.4 years)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from screening to follow-up (up to 1.4 years)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from screening to follow-up (up to 1.4 years) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change from baseline in specific airway volume (siVaw)

Secondary study objectives

Change from baseline in Airway resistance (iRaw)

Change from baseline in Airway volume (iVaww)

Change from baseline in BVX with and without adjustment for pre-BD FEV1

+36 more

Side effects data

From 2016 Phase 3 trial • 220 Patients • NCT02075255

15%

Nasopharyngitis

Asthma

Sinusitis

Headache

Bronchitis

Upper respiratory tract infection

Influenza

Back pain

Cough

Dyspnoea

Hypertension

Rhinitis

Urosepsis

Nephrolithiasis

Intervertebral disc protrusion

Umbilical hernia

Adverse drug reaction

Hypersensitivity

Vertigo

Nausea

Dermatitis atopic

Urinary tract infection bacterial

100%

80%

60%

40%

20%

Study treatment Arm

Benra 30 mg q.4 Weeks

Benra 30 mg q.8 Weeks

Placebo

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups

Experimental Treatment

Group I: BenralizumabExperimental Treatment1 Intervention

Participants will receive 3 doses of benralizumab having a strength of 30 mg subcutaneously once every 4 weeks (Week 0, Week 4, and Week 8).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Benralizumab

2016

Completed Phase 4

~10320

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Asthma treatments often target the underlying inflammation and bronchoconstriction characteristic of the disease. Common treatments include inhaled corticosteroids (ICS) that reduce airway inflammation, and long-acting beta-agonists (LABA) that relax bronchial muscles to improve airflow. Biological therapies, such as Benralizumab, target specific pathways involved in asthma. Benralizumab is an anti-IL-5 receptor monoclonal antibody that depletes eosinophils, a type of white blood cell that contributes to airway inflammation and hyper-responsiveness in eosinophilic asthma. By reducing eosinophil levels, Benralizumab can decrease the frequency of asthma exacerbations and improve lung function. Understanding these mechanisms is crucial for asthma patients as it helps tailor treatments to their specific type of asthma, potentially leading to better disease management and improved quality of life.