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

Who is this study for? Patients with severe eosinophilic asthma
What treatments are being studied? Benralizumab
Status: Recruiting
Location: See all (53) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• Male or female aged 18 through 70 years.

• Physician-diagnosed asthma requiring continuous treatment with medium- or high-dose ICS plus LABA with or without additional controller medication for at least 12 months prior to Visit 1, and current treatment with high-dose ICS plus LABA for at least 3 months prior to Visit 1 with or without additional asthma maintenance medication.

• Morning pre-BD FEV1 ≥50 to \<80% of predicted normal value (PNV) and ≥1 liter (L) or morning pre-BD FEV1 ≥ 50 to \< 90% of PNV, if historical pre-BD FEV1 value (within 12 months prior to screening visit) was \< 80% of PNV.

• A blood eosinophil count meeting any of 3 criteria: ≥300 cells/µL during screening or ≥ 220 to \< 300 cells/μL during screening and documented eosinophil count of ≥ 300 cells/μL in the past 12 months, or ≥150 to \<300 cells/µL during screening plus one of the following: presence of nasal polyps or pre-BD FVC \<65% predicted at Visit 2

• Negative pregnancy test.

• Asthma control questionnaire (ACQ-6) \>1.5.

• Fewer than 12 exacerbations within the 6 months prior to Visit 3.

Locations
United States
Alabama
Research Site
RECRUITING
Birmingham
California
Research Site
RECRUITING
Los Angeles
Research Site
WITHDRAWN
Los Angeles
Florida
Research Site
WITHDRAWN
Jacksonville
Research Site
RECRUITING
Jacksonville
Research Site
RECRUITING
Miami
Georgia
Research Site
WITHDRAWN
Decatur
Research Site
RECRUITING
Snellville
Iowa
Research Site
ACTIVE_NOT_RECRUITING
Iowa City
Indiana
Research Site
RECRUITING
Indianapolis
Kansas
Research Site
WITHDRAWN
Hutchinson
Research Site
RECRUITING
Kansas City
Massachusetts
Research Site
WITHDRAWN
Boston
Maryland
Research Site
WITHDRAWN
Baltimore
Michigan
Research Site
RECRUITING
Ann Arbor
Research Site
RECRUITING
Bloomfield Hills
Minnesota
Research Site
RECRUITING
Rochester
Missouri
Research Site
RECRUITING
St Louis
North Carolina
Research Site
WITHDRAWN
Durham
Research Site
TERMINATED
New Bern
Research Site
ACTIVE_NOT_RECRUITING
Winston-salem
New York
Research Site
RECRUITING
Maspeth
Research Site
WITHDRAWN
Port Jefferson Station
Pennsylvania
Research Site
WITHDRAWN
Philadelphia
Research Site
WITHDRAWN
Philadelphia
Research Site
ACTIVE_NOT_RECRUITING
Pittsburgh
Research Site
WITHDRAWN
Sayre
South Carolina
Research Site
WITHDRAWN
Charleston
Texas
Research Site
RECRUITING
Galveston
Research Site
RECRUITING
Lewisville
Research Site
RECRUITING
Mansfield
Research Site
WITHDRAWN
Mcallen
Research Site
WITHDRAWN
Mckinney
Virginia
Research Site
WITHDRAWN
Williamsburg
Other Locations
Canada
Research Site
RECRUITING
Calgary
Research Site
WITHDRAWN
Edmonton
Research Site
WITHDRAWN
Hamilton
Denmark
Research Site
RECRUITING
Aalborg
Research Site
COMPLETED
Aarhus N
Research Site
RECRUITING
Copenhagen
Research Site
COMPLETED
Hvidovre
Research Site
RECRUITING
Næstved
Research Site
COMPLETED
Odense C
Research Site
COMPLETED
Vejle
Sweden
Research Site
RECRUITING
Gothenburg
Research Site
COMPLETED
Lund
United Kingdom
Research Site
RECRUITING
Cambridge
Research Site
COMPLETED
Headington
Research Site
RECRUITING
Leicester
Research Site
RECRUITING
Liverpool
Research Site
RECRUITING
London
Research Site
WITHDRAWN
London
Research Site
COMPLETED
Wythenshawe
Contact Information
Primary
AstraZeneca Clinical Study Information Center
information.center@astrazeneca.com
1-877-240-9479
Time Frame
Start Date: 2019-10-17
Estimated Completion Date: 2026-09-09
Participants
Target number of participants: 81
Treatments
Experimental: Benralizumab
Administrated subcutaneously (SC) every 4 weeks for the first 3 doses, then every 8 weeks
Placebo_comparator: Placebo
Administrated subcutaneously every 4 weeks for the first 3 doses, then every 8 weeks
Related Therapeutic Areas
Sponsors
Leads: AstraZeneca

This content was sourced from clinicaltrials.gov

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