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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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up over the db treatment period (28 to 52 weeks)
Awards & highlights

MAHALE Trial Summary

This trial is testing if a drug called benralizumab can help reduce exacerbation rates for people with non-cystic fibrosis bronchiectasis who also have eosinophilic inflammation. The trial will last for 52 weeks, and patients who complete the trial will be eligible for an extension where they will receive the drug for at least one more year.

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.Check my eligibility
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.See study design
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.

MAHALE Trial 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 antibiotic treatment for preventing lung issues has been stable for 3 months.
Select...
I am 18 years old or older.
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I have been on a stable lung therapy for mucus clearance for at least 3 months.
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I have been diagnosed with NCFB confirmed by a recent CT scan.
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My asthma medication dose has been stable for the last 3 months.
Select...
I've had 2 or more flare-ups of my lung condition in the last year.
Select...
I am 18 years old or older.

MAHALE Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Annualised exacerbation rate
Secondary outcome measures
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
+4 more
Other outcome measures
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
Placebo
Benra 30 mg q.8 Weeks

MAHALE 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 3
~10580

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,238 Previous Clinical Trials
288,471,321 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any previous case studies of patients being treated with Benralizumab?

"Out of the 20 ongoing studies on Benralizumab, 10 are currently in Phase 3. The majority of these studies are situated in Bethesda, Maryland; however, there are 1,481 total clinical trial sites for this medication."

Answered by AI

Are we looking for test subjects who are over the age of 35 for this experiment?

"The acceptable age range for participants in this trial is between 18 and 130 years old."

Answered by AI

What have been the most serious side effects associated with Benralizumab?

"Benralizumab is in Phase 3 of clinical trials, which implies that there is some data affirming its efficacy and multiple rounds of data affirming its safety--our team at Power rated it a 3 on a scale from 1 to 3."

Answered by AI

What is the largest number of people who can sign up for this research project?

"Unfortunately, this trial is not presently looking for new candidates. The study was originally posted on 7/21/2021 but was most recently edited on 8/24/2022. For patients looking for other studies, 438 trials actively enrolling patients with bronchiectasis and 20 trials for Benralizumab are searching for participants."

Answered by AI

Does this research mark a new era in this field of study?

"Benralizumab was first studied in 2014 with Phase 2 & 3 approval coming later. Currently, there are 20 active studies being conducted in 352 cities across 42 countries."

Answered by AI

Could you tell me how many hospitals are participating in this trial at the moment?

"Enrollment for this clinical trial is currently open at 18 sites, which are situated in Newport Beach, Washington, Statesville, and other cities. To reduce the burden of travel, patients are encouraged to enroll at the location nearest to them."

Answered by AI

What are the requirements for subjects in this clinical trial?

"This study is seeking 79 individuals, aged 18 to 130, who have bronchiectasis and are currently receiving airway clearance therapy, physiotherapy, or mucus clearance therapy. The dose and regimen of these therapies and any drugs used to aid expectoration must be stable for at least 3 months prior to the screening visit and remain stable throughout the study. Male or female patients who meet the following criteria are eligible for inclusion: a documented history of 2 or more bronchiectasis exacerbations within a year of the screening visit, no recent prophylactic antibiotic use (if prophylactic macrolides have been recently"

Answered by AI

Can people with the disease still sign up to participate in the research?

"This clinical trial is not presently searching for candidates anymore. The trial was initially posted on 7/21/2021 and was last updated on 8/24/2022. If you are seeking for other studies, there are currently 438 trials actively looking for participants with bronchiectasis and 20 studies for Benralizumab actively enrolling participants."

Answered by AI

Who else is applying?

What state do they live in?
Tennessee
Florida
How old are they?
18 - 65
What site did they apply to?
Research Site
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria

Why did patients apply to this trial?

~3 spots leftby May 2024