NCT05006573

Efficacy and Safety of Benralizumab in Patients With Non-cystic Fibrosis Bronchiectasis

A Multicentre, Randomised, Double-blind, Parallel-group, Placebo-controlled, 52 Week, Phase III Study With an Open-label Extension to Evaluate the Efficacy and Safety of Benralizumab in Patients With Non-Cystic Fibrosis Bronchiectasis (MAHALE)

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 130 Years
• Healthy volunteers: Not accepted

Summary

This is a multicentre, randomised, double-blind, parallel-group, placebo-controlled, phase III study originally designed to test the hypothesis that benralizumab will reduce exacerbation rates compared with placebo on top of standard-of-care therapy in adult patients with non-cystic fibrosis bronchiectasis with eosinophilic inflammation (NCFB+EI). All patients who complete the double-blind treatment period (28 to 52 weeks depending on the timing of patient randomization and when the revised CSP version 3.0 becomes effective) on investigational product (IP) may be eligible to continue into an open-label extension (OLE) period during which all patients will receive benralizumab. The revised OLE period is intended to allow patients approximately 32 weeks of treatment with open label benralizumab (24 weeks followed by a FU visit 8 weeks after the last dose of IP for a total of approximately 32 weeks).

Conditions

• Non-cystic Fibrosis Bronchiectasis

Interventions

Type	Name	Description
BIOLOGICAL	Benralizumab	Benralizumab active solution in a single accessorized prefilled syringe (APFS) will be administered subcutaneously (SC), 1 mL fill volume
BIOLOGICAL	Placebo to Benralizumab	Matching placebo solution in a single accessorized prefilled syringe (APFS) will be administered subcutaneously (SC), 1 mL fill volume

Timeline

• Start date: 2021-07-21
• Primary completion: 2024-04-16
• Completion: 2024-04-16
• First posted: 2021-08-16
• Last updated: 2025-07-20
• Results posted: 2025-07-20

Locations

48 sites across 16 countries: United States, Argentina, Australia, Canada, China, Denmark, Germany, India, Italy, Philippines, Poland, Russia, South Korea, Spain, United Kingdom, Vietnam

Regulatory

• FDA-regulated drug study