Clinical Trial Details

NCT ID: NCT03170271
Date Last Changed: September 22, 2017

Overview

Research Study Summary

Patients are needed to participate in a clinical research study evaluating Benralizumab (Medi-563) and Placebo for the treatment of Asthma

Research Study Title

A Multicenter, Randomized, Double-blind, Parallel Group, Placebo Controlled, Phase 3b Study to Evaluate the Safety and Efficacy of Benralizumab 30 mg sc in Patients With Severe Asthma Uncontrolled on Standard of Care Treatment

Purpose

The purpose of this study is to investigate the effect of benralizumab on the rate of asthma exacerbations, patient reported quality of life and lung function during 24-week treatment in patients with uncontrolled, severe asthma with eosinophilic inflammation. A subset of patients will be assessed for their ongoing chronic rhinosinusitis with nasal polyps.

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Recruitment Details

Phase
3
Gender
All
Age
N/A
Overall Status
Recruiting
Lead Sponsor
AstraZeneca
Duration
22 Months
Facility Type
N/A
Compensation

Eligibility

All ages up to N/A

Inclusion Criteria:

  1. Female and male patients aged 18 to 75 years inclusively at the time of Visit 1 with a history of physician-diagnosed asthma requiring treatment with medium-to-high dose Inhaled Corticosteroids (ICS) plus asthma controller, for at least 12 months prior to Visit 1.

  2. Documented current treatment with high daily doses of ICS plus at least one other asthma controller for at least 3 months prior to Visit 1.

  3. History of at least 2 asthma exacerbations while on ICS plus another asthma controller that required treatment with systemic corticosteroids (IM, IV, or oral) in the 12 months prior to Visit 1.

  4. ACQ6 score ≥1.5 at Visit 1.

  5. Screening pre-bronchodilator (pre-BD) FEV1 of < 80% predicted at Visit 2 and airway reversibility (FEV1 ≥12%) demonstrated at Visit 2 or Visit 3.

  6. Peripheral blood eosinophil count of ≥300 cells/μL assessed by central laboratory at Visit 1 or Visit 2.

Exclusion Criteria:

  1. Clinically important pulmonary disease other than asthma

  2. Acute upper or lower respiratory infections within 30 days prior to the date informed consent.

  3. A helminth parasitic infection diagnosed within 24 weeks prior to the date informed consent is obtained that has not been treated with, or has failed to respond to, standard of care therapy.

  4. History of alcohol or drug abuse within 12 months prior to the date informed consent is obtained.

  5. A history of known immunodeficiency disorder.

  6. Current smokers or former smokers with a smoking history of ≥10 pack years.

  7. Previously received benralizumab (MEDI-563).

  8. Receipt of any investigational medication as part of a research study within approximately 5 half-lives prior to randomization.

  9. Receipt of immunoglobulin or blood products within 30 days prior to the date informed consent is obtained.

  10. Receipt of live attenuated vaccines 30 days prior to the date of randomization; other types of vaccines are allowed.

  11. Concurrent enrolment in another interventional or post-authorization safety study

Site Locations (53)

Country State City Zip Facility and Contact
United States California Mission Viejo 92691 Research Site
United States California Napa 94558 Research Site
United States California Newport Beach 92663 Research Site
United States California Riverside 92506 Research Site
United States California Walnut Creek 94598 Research Site
United States Connecticut Waterbury 06708 Research Site
United States Florida Aventura 33180 Research Site
United States Georgia Albany 31707 Research Site
United States Georgia Savannah 31406 Research Site

Brad Goodman, MD
Principal Investigator
United States Indiana South Bend 46617 Research Site
United States Louisiana Shreveport 71106 Research Site
United States Maryland Chevy Chase 20815 Research Site
United States Maryland Waldorf 20602 Research Site
United States Massachusetts North Dartmouth 02747 Research Site
United States Michigan Ypsilanti 48197 Research Site
United States Minnesota Minneapolis 55402 Research Site
United States Missouri Saint Louis 63110 Research Site
United States Nebraska Lincoln 68505 Research Site
United States Nebraska Lincoln 68506 Research Site
United States New Jersey Highland Park 08904 Research Site
United States New Jersey Piscataway 08854 Research Site
United States New Jersey Toms River 08755 Research Site

Vinay Sikand, MD
Principal Investigator
United States New Jersey Verona 70447810 Research Site
United States New Mexico Albuquerque 87109 Research Site
United States New York New York 10016 Research Site
United States New York Rochester 14618 Research Site
United States New York The Bronx 10459 Research Site
United States North Carolina Charlotte 28207 Research Site
United States North Carolina Elizabeth City 27909 Research Site
United States North Carolina Gastonia 28054 Research Site
United States North Carolina High Point 27262 Research Site
United States North Carolina Winston-Salem 27103 Research Site
United States Ohio Cincinnati 45231 Research Site
United States Ohio Columbus 43231 Research Site
United States Oklahoma Tulsa 74136 Research Site
United States Oregon Portland 97015 Research Site
United States Pennsylvania Pittsburgh 15241 Research Site
United States Pennsylvania Wyomissing 19610 Research Site
United States South Carolina Anderson 29621 Research Site
United States South Carolina Easley 29640 Research Site
United States South Carolina Gaffney 23940 Research Site
United States South Carolina Greenville 29607 Research Site
United States South Carolina Greenville 29615 Research Site
United States South Carolina Rock Hill 29732 Research Site
United States South Dakota Sioux Falls 57108 Research Site
United States Texas Fort Worth 76109 Research Site
United States Texas San Antonio 78251 Research Site
United States Utah Provo 84604 Research Site
United States Vermont Burlington 05403 Research Site
United States Virginia Abingdon 24210 Research Site
United States Virginia Richmond 23225 Research Site
United States Washington Spokane 99202 Research Site
United States Wisconsin West Allis 53227 Research Site

Contact

AstraZeneca Clinical Study Information Center
1-877-240-9479
E-mail:

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