Benralizumab for Bronchiectasis

(MAHALE Trial)

Recruiting at 91 trial locations

Overseen By AstraZeneca Clinical Study Information Center

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: AstraZeneca

Must be taking: Inhaled corticosteroids, Bronchodilators

Must not be taking: Immunosuppressives, Biologics

Disqualifiers: Pulmonary disease, Liver disease, Malignancy, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

100 Participants Needed

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Double-blind Treatment

Participants receive either benralizumab or placebo for 28 to 52 weeks

28 to 52 weeks

Open-label Extension

Participants receive open-label benralizumab for 24 weeks followed by a follow-up visit 8 weeks after the last dose

32 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

8 weeks

Treatment Details

Interventions

• Benralizumab
• Placebo to Benralizumab

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 European Union, United States, Canada, Japan for the following indications:

Approved in European Union as Fasenra for:

• Severe eosinophilic asthma

Approved in United States as Fasenra for:

• Severe asthma with an eosinophilic phenotype

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