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ACTIVE NOT RECRUITING
NCT03953300
PHASE4

Benralizumab Airway Remodeling Study in Severe Eosinophilic Asthmatics

Sponsor: AstraZeneca

View on ClinicalTrials.gov

Summary

The purpose of the study is to evaluate effect of benralizumab on structural and lung function changes in severe eosinophilic asthmatics. Changes will be assessed over 48 week treatment period in patients with persistent symptoms despite standard therapy of inhaled corticosteroids (ICS) plus long acting B2-agonist (LABA) with or without additional controller medication. Patients who complete treatment will enter 4 weeks follow-up period.

Official title: A Phase 4, Multicenter, Randomized, Double-blind, Parallel Group, Placebo Controlled Study to Evaluate the Effect of Benralizumab on Structural and Lung Function Changes in Severe Eosinophilic Asthmatics

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

75

Start Date

2019-10-08

Completion Date

2026-10-19

Last Updated

2026-04-09

Healthy Volunteers

No

Conditions

Interventions

BIOLOGICAL

Benralizumab

Benralizumab: 30 mg/mL solution for injection in accessorized prefilled syringe (APFS) will be administered subcutaneously (SC) every 4 weeks for the first 3 doses - Weeks 0, 4 and 8, and then every 8 weeks - Weeks 16, 24, 32, 40.

BIOLOGICAL

Placebo

Matching placebo will be administered subcutaneously with accessorized prefilled syringe (APFS) every 4 weeks for the first 3 doses - Weeks 0, 4 and 8, and then every 8 weeks - Weeks 16, 24, 32, 40.

Locations (35)

Research Site

Birmingham, Alabama, United States

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Los Angeles, California, United States

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Jacksonville, Florida, United States

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Miami, Florida, United States

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Snellville, Georgia, United States

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Indianapolis, Indiana, United States

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Iowa City, Iowa, United States

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Kansas City, Kansas, United States

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Ann Arbor, Michigan, United States

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Bloomfield Hills, Michigan, United States

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Rochester, Minnesota, United States

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St Louis, Missouri, United States

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Maspeth, New York, United States

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New Bern, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Pittsburgh, Pennsylvania, United States

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Galveston, Texas, United States

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Lewisville, Texas, United States

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Mansfield, Texas, United States

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Calgary, Alberta, Canada

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Aalborg, Denmark

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Aarhus N, Denmark

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Copenhagen, Denmark

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Hvidovre, Denmark

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Næstved, Denmark

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Odense C, Denmark

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Vejle, Denmark

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Gothenburg, Sweden

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Lund, Sweden

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Cambridge, United Kingdom

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Headington, United Kingdom

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Leicester, United Kingdom

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Liverpool, United Kingdom

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London, United Kingdom

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Wythenshawe, United Kingdom