Benralizumab for Bronchiectasis
(MAHALE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether benralizumab (also known as Fasenra) can reduce flare-ups in people with non-cystic fibrosis bronchiectasis, a lung condition that causes frequent infections and mucus build-up. Participants will receive either benralizumab or a placebo (an inactive substance) to compare effects. Ideal candidates are adults with this lung condition confirmed by a scan and at least two flare-ups in the past year. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.
Will I have to stop taking my current medications?
You may need to stop certain medications before joining the trial. If you're on prophylactic antibiotics, you must have been off them for at least 3 months or have a 4-week break before starting the trial. Other medications like inhaled corticosteroids or bronchodilators should remain stable for at least 3 months before and during the study.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that benralizumab is generally well-tolerated. In studies where patients used benralizumab for other conditions, common side effects included colds, worsening asthma, bronchitis, and headaches. These side effects occurred in more than 5 out of 100 patients each year.
The FDA has approved this treatment for other uses, such as severe asthma, indicating its safety for those conditions. However, each condition differs, and safety can vary. Always consult a healthcare provider about potential risks and benefits before joining a trial.12345Why do researchers think this study treatment might be promising for bronchiectasis?
Benralizumab is unique because it targets and reduces eosinophils, a type of white blood cell often involved in inflammation, particularly in respiratory conditions like bronchiectasis. Unlike standard treatments, which typically manage symptoms with antibiotics and airway clearance techniques, Benralizumab works by specifically binding to the interleukin-5 receptor on eosinophils, leading to their depletion. Researchers are excited about this treatment because it offers a targeted approach that might significantly improve lung function and reduce flare-ups in patients with eosinophilic-driven bronchiectasis.
What evidence suggests that benralizumab might be an effective treatment for bronchiectasis?
Research has shown that benralizumab, which participants in this trial may receive, can help reduce flare-ups in individuals with severe eosinophilic asthma related to bronchiectasis. Studies have found that benralizumab quickly improves lung function and reduces the need for oral corticosteroids, often used to manage symptoms. This treatment targets a specific type of inflammation in the immune system found in non-cystic fibrosis bronchiectasis. Individuals with similar conditions have experienced fewer flare-ups and better breathing after using benralizumab. These findings suggest it could help those with bronchiectasis manage their symptoms more effectively.12367
Who Is on the Research Team?
James D. Chalmers, MD
Principal Investigator
University of Dundee, Nethergate, Dundee DD1 4HN, Scotland, UK
Are You a Good Fit for This Trial?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Double-blind Treatment
Participants receive either benralizumab or placebo for 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
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
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.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
Benralizumab will be administered subcutaneously (SC) using an accessorized prefilled syringe (APFS)
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:
- Severe eosinophilic asthma
- Severe asthma with an eosinophilic phenotype
- Severe eosinophilic asthma
- Severe eosinophilic asthma
Find a Clinic Near You
Who Is Running the Clinical Trial?
AstraZeneca
Lead Sponsor
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
Citations
Benralizumab Effectiveness in Severe Eosinophilic Asthma ...
Results: We included 74 patients with SEA treated with benralizumab, of which 35 (47.2%) showed the co-presence of bronchiectasis (SEA + BE) ...
Benralizumab Outcomes in Patients with Severe Eosinophilic ...
The findings support the effectiveness of benralizumab at multiple levels: reductions in exacerbation and mOCS use and improvements in lung ...
Rapid Benralizumab effectiveness in patients with severe ...
Conclusion: Benralizumab determined a very rapid clinical and functional improvement in patients with severe eosinophilic asthma and BE. Footnotes. Cite this ...
Efficacy and Safety of Benralizumab in Patients With Non ...
Outcome Measures. 1. Primary Outcome Measure: Annualized bronchiectasis exacerbations rate in the double-blind period [ Time Frame: through Double-blind ...
NCT05006573 | Efficacy and Safety of Benralizumab in ...
Benralizumab will reduce exacerbation rates compared with placebo on top of standard-of-care therapy in adult patients with non-cystic fibrosis bronchiectasis.
Safety Profile | FASENRA® (benralizumab) | For HCPs
Most common AEs (≥5 per 100 patient-years in the FASENRA Q8W arm) were nasopharyngitis, worsening asthma, bronchitis, and headache.§1. NO. trend toward ...
Benralizumab efficacy and safety in severe asthma
Benralizumab treatment significantly reduced AAER, and improved lung function, asthma symptoms, symptom control, and HRQoL in patients from Asia with SEA. These ...
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