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Monoclonal Antibodies

Benralizumab for Bronchiectasis (MAHALE Trial)

Phase 3
Waitlist Available
Led By James D. Chalmers, MD
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Documented history of 2 or more bronchiectasis exacerbations within a year of the screening visit.
Must be on airway clearance therapy, physiotherapy, or mucus clearance therapy.The dose and regimen of these therapies and any drugs used to aid expectoration should be stable for at least 3 months prior to the screening visit and remain stable throughout the DB period of the study.
Must not have
Current active liver disease
Use of immunosuppressive medication within 3 months of the screening visit or expected need for chronic use (≥ 4 weeks) during study
Timeline
Screening 3 weeks
Treatment Varies
Follow Up over the db treatment period (28 to 52 weeks)
Awards & highlights

Summary

This trial tests if benralizumab can reduce lung flare-ups in adults with a specific lung condition involving high eosinophil levels. The medication works by lowering certain white blood cells that cause inflammation. Benralizumab helps improve lung function for patients with severe, uncontrolled asthma with eosinophilic inflammation.

Who is the study for?
Adults over 18 with non-cystic fibrosis bronchiectasis confirmed by CT, experiencing at least two exacerbations in the past year. They must be on stable airway clearance or mucus therapy for three months prior to screening and agree to use effective birth control if applicable. Excluded are those with recent infections, drug abuse history, other diseases causing high eosinophil counts, certain cancers, unstable health conditions, or using specific treatments like long-term oxygen.
What is being tested?
The trial is testing Benralizumab against a placebo in addition to standard care for reducing exacerbation rates in patients with bronchiectasis and eosinophilic inflammation. It's a phase III study where participants are randomly assigned to either the medication or placebo group and may enter an open-label extension after completing initial treatment.
What are the potential side effects?
While not specified here, common side effects of drugs like Benralizumab can include headache, fatigue, allergic reactions at injection site. More serious risks might involve weakening of immune system leading to increased risk of infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I've had 2 or more flare-ups of my lung condition in the last year.
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I have been on a stable lung therapy for mucus clearance for at least 3 months.
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My asthma medication dose has been stable for the last 3 months.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have an ongoing liver condition.
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I haven't taken immunosuppressive drugs in the last 3 months and don't expect to need them.
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I am on long-term oxygen therapy.
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I haven't taken any experimental drugs within the last 30 days or 5 half-lives.
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I have not received any live vaccines in the last 30 days.
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I have smoked at least 10 pack-years.
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I have had a lung infection or worsening of my bronchiectasis recently.
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I have a condition that increases my eosinophil count.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~over the db treatment period (28 to 52 weeks)
This trial's timeline: 3 weeks for screening, Varies for treatment, and over the db treatment period (28 to 52 weeks) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Annualised exacerbation rate
Secondary study objectives
Change from baseline in LCQ
Change from baseline in QoL-B scales (excluding QoL-B-RSS secondary endpoint)
Change from baseline in QoL-B-RSS
+3 more
Other study objectives
Anti-drug antibodies (ADA) as a measure of immunogenicity
Serum benralizumab concentration as a measure of pharmacokinetics

Side effects data

From 2016 Phase 3 trial • 220 Patients • NCT02075255
15%
Nasopharyngitis
8%
Asthma
7%
Sinusitis
7%
Headache
7%
Bronchitis
6%
Upper respiratory tract infection
4%
Influenza
3%
Back pain
3%
Cough
3%
Dyspnoea
3%
Hypertension
3%
Rhinitis
1%
Urosepsis
1%
Nephrolithiasis
1%
Intervertebral disc protrusion
1%
Umbilical hernia
1%
Adverse drug reaction
1%
Hypersensitivity
1%
Vertigo
1%
Nausea
1%
Dermatitis atopic
1%
Urinary tract infection bacterial
100%
80%
60%
40%
20%
0%
Study treatment Arm
Benra 30 mg q.4 Weeks
Benra 30 mg q.8 Weeks
Placebo

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: BenralizumabExperimental Treatment1 Intervention
Benralizumab will be administered subcutaneously (SC) using an accessorized prefilled syringe (APFS)
Group II: PlaceboPlacebo Group1 Intervention
Matching placebo solution will be administered subcutaneously (SC) using an accessorized prefilled syringe (APFS)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Benralizumab
2016
Completed Phase 4
~10540

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
Common treatments for Bronchiectasis include antibiotics, bronchodilators, and anti-inflammatory agents. Antibiotics target bacterial infections, reducing inflammation and preventing exacerbations. Bronchodilators, such as beta-agonists and anticholinergics, relax airway muscles, improving airflow and reducing symptoms. Anti-inflammatory agents, including corticosteroids and monoclonal antibodies like Benralizumab, reduce inflammation by targeting specific pathways. Benralizumab, an anti-eosinophil monoclonal antibody, targets the IL-5 receptor, reducing eosinophil levels and inflammation. This is crucial for Bronchiectasis patients as it helps manage chronic inflammation, reduces exacerbations, and improves overall lung function.

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,352 Previous Clinical Trials
288,646,709 Total Patients Enrolled
2 Trials studying Bronchiectasis
121 Patients Enrolled for Bronchiectasis
James D. Chalmers, MDPrincipal InvestigatorUniversity of Dundee, Nethergate, Dundee DD1 4HN, Scotland, UK
~24 spots leftby Sep 2025
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