Benralizumab for Bronchiectasis

(MAHALE Trial)

Recruiting at91 trial locations

Overseen by James D. Chalmers, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: AstraZeneca

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Research Team

James D. Chalmers, MD

Principal Investigator

University of Dundee, Nethergate, Dundee DD1 4HN, Scotland, UK

Eligibility Criteria

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.

Inclusion Criteria

I've had 2 or more flare-ups of my lung condition in the last year.

I have been on a stable lung therapy for mucus clearance for at least 3 months.

My asthma medication dose has been stable for the last 3 months.

Exclusion Criteria

I am in or about to start an intensive lung rehab program, or I am in the maintenance phase of one.

Judgement by the Investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions, and requirements

I have an ongoing liver condition.

Treatment Details

Interventions

• Benralizumab (Monoclonal Antibodies)
• Placebo to Benralizumab (Other)

Trial Overview 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.

Participant Groups

Group I: Benralizumab Experimental Treatment 1 Intervention

Benralizumab will be administered subcutaneously (SC) using an accessorized prefilled syringe (APFS)

Group II: Placebo Placebo Group 1 Intervention

Matching placebo solution will be administered subcutaneously (SC) using an accessorized prefilled syringe (APFS)

Benralizumab is already approved in Canada, Japan for the following indications:

Approved in Canada as Fasenra for:

• Severe eosinophilic asthma

Approved in Japan as Fasenra for:

• Severe eosinophilic asthma

Who Is Running the Clinical Trial?

AstraZeneca

Lead 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