What side effects are associated with this type of intervention?

Common treatments for severe eosinophilic asthma, such as Benralizumab, Mepolizumab, and Dupilumab, generally involve biologic therapies targeting specific pathways in the immune system. Known side effects of these treatments include injection site reactions, upper respiratory tract infections, headache, and nasopharyngitis. More serious but less common adverse effects can include hypersensitivity reactions and, in rare cases, more severe infections or cardiovascular events. It is important for patients to discuss these potential side effects with their healthcare provider to weigh the benefits and risks of these treatments.

What prior FDA approvals exist?

Several biologic agents have been approved by the FDA for the treatment of asthma, particularly targeting severe eosinophilic asthma. Benralizumab, an anti-IL-5 receptor monoclonal antibody, reduces eosinophils and is used for severe eosinophilic asthma. Other similar treatments include Mepolizumab and Reslizumab, both of which are anti-IL-5 monoclonal antibodies that also target and reduce eosinophils. Dupilumab, an anti-IL-4 receptor alpha monoclonal antibody, inhibits IL-4 and IL-13 signaling and is approved for moderate-to-severe asthma. Tezepelumab, targeting thymic stromal lymphopoietin (TSLP), is another biologic approved for severe asthma. These treatments represent a significant advancement in targeting specific inflammatory pathways in asthma management.

What other types of research exist?

Promising alternatives to Benralizumab for asthma patients include Dupilumab (an IL-4 and IL-13 inhibitor), Omalizumab (an anti-IgE antibody), and Tezepelumab (an anti-TSLP antibody). These therapies have shown efficacy in reducing asthma exacerbations and improving lung function in clinical trials.

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Monoclonal Antibodies

Benralizumab for Asthma (DOMINICA Trial)

Q: What is the mechanism of action of this treatment?

Asthma treatments work through various mechanisms to reduce inflammation, relax airway muscles, and prevent exacerbations. Biologics like benralizumab target specific pathways involved in asthma. Benralizumab is an anti-IL-5 receptor monoclonal antibody that reduces eosinophils, which are white blood cells that contribute to inflammation and asthma severity. By lowering eosinophil levels, benralizumab helps decrease asthma exacerbations and improve lung function. Other common treatments include inhaled corticosteroids (ICS) that reduce airway inflammation, long-acting beta-agonists (LABA) that relax airway muscles, and leukotriene modifiers that block inflammatory chemicals. These treatments are crucial for managing asthma symptoms, preventing attacks, and improving the quality of life for asthma patients.

Phase 3

Recruiting

Research Sponsored by AstraZeneca

Eligibility Criteria Checklist

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

Must have

Patients with an exacerbation history of asthma exacerbations (defined as a requirement for systemic corticosteroids and/or hospitalization) within 12 months prior to Visit 1, OR, 2 asthma exacerbations (defined as a requirement for systemic corticosteroids and/or hospitalization) per year within the 2 years prior to Visit 1 AND, one or more of the following: Currently on stable maintenance oral corticosteroids (OCS) used for at least 3 months prior to Visit 1, OR, At least one of the 2 exacerbations that occurred in the year prior to Visit 1 resulted in hospitalisation.

Male or female patients aged ≥ 6 to < 18 years old.

Must not have

Life-threatening asthma

Current malignancy, or history of malignancy.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from screening period until eot db treatment period

Awards & highlights

Pivotal Trial

Summary

This trial tests benralizumab, an injectable medication, in children and teenagers aged 6 to 18 with severe eosinophilic asthma. The medication works by reducing specific white blood cells that cause lung inflammation, helping to control asthma symptoms. Benralizumab helps improve lung function for patients with severe, uncontrolled asthma with eosinophilic inflammation.

Who is the study for?

This trial is for children and teenagers aged 6 to under 18 with severe eosinophilic asthma. They must have a history of asthma exacerbations, be on high-dose inhaled corticosteroids plus another controller medication, and show certain levels of blood eosinophils. Females who can bear children must use effective contraception. Those with recent respiratory infections or steroid use, other significant health issues, or previous benralizumab treatment are excluded.

What is being tested?

The study tests the effectiveness and safety of benralizumab given by injection compared to a placebo in managing severe eosinophilic asthma in young patients. It focuses on reducing the number of asthma attacks (exacerbations) while monitoring any potential side effects from the treatment.

What are the potential side effects?

Potential side effects include allergic reactions to the drug's components which could range from mild skin reactions to more serious conditions like anaphylaxis. As it's an immune-modulating therapy, there may also be increased risks of infections.

Eligibility Criteria

Inclusion Criteria

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

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I have had severe asthma attacks needing steroids or hospital visits.

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I am between 6 and 17 years old.

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My asthma is linked to high eosinophil levels in my blood or lung tests.

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My lung function test shows reduced airflow.

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My body weight is at least 15 kg.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have severe asthma that could endanger my life.

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I have or had cancer.

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I haven't needed steroids for asthma or had a serious respiratory infection in the last 2 weeks.

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I have been treated with benralizumab before.

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I am currently taking medication that suppresses my immune system.

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I have a worm infection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ during day -7, day 56, day 112, every 16 weeks and at eot db treatment period

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~during day -7, day 56, day 112, every 16 weeks and at eot db treatment period

This trial's timeline: 3 weeks for screening, Varies for treatment, and during day -7, day 56, day 112, every 16 weeks and at eot db treatment period for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Time to first asthma exacerbation

Secondary study objectives

Anti-benralizumab antibodies

Change from baseline, during the DB treatment period in Asthma symptom score

Change from baseline, during the DB treatment period in Interviewer-Administered Version of the Asthma Control Questionnaire (ACQ-IA)

+8 more

Other study objectives

Number of patients with Adverse events (AEs) and Serious adverse events (SAEs)

The AAER in the OLE period

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

Pivotal Trial

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

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: BenralizumabExperimental Treatment1 Intervention

Patients will receive Benralizumab as an active solution via a subcutaneous (SC) injection.

Group II: PlaceboPlacebo Group1 Intervention

Patients will receive a matching solution of the placebo via SC injection.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Benralizumab

2016

Completed Phase 4

~10320

0 / 11Eligibility 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 work through various mechanisms to reduce inflammation, relax airway muscles, and prevent exacerbations. Biologics like benralizumab target specific pathways involved in asthma. Benralizumab is an anti-IL-5 receptor monoclonal antibody that reduces eosinophils, which are white blood cells that contribute to inflammation and asthma severity. By lowering eosinophil levels, benralizumab helps decrease asthma exacerbations and improve lung function. Other common treatments include inhaled corticosteroids (ICS) that reduce airway inflammation, long-acting beta-agonists (LABA) that relax airway muscles, and leukotriene modifiers that block inflammatory chemicals. These treatments are crucial for managing asthma symptoms, preventing attacks, and improving the quality of life for asthma patients.