Spots Global Cancer Trial Database for Efficacy and Safety Study of Benralizumab for Patients With Severe Nasal Polyposis
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Trial Identification
Brief Title: Efficacy and Safety Study of Benralizumab for Patients With Severe Nasal Polyposis
Official Title: A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Phase 3 Efficacy and Safety Study Of Benralizumab in Patients With Severe Nasal Polyposis
Study ID: NCT03401229
Conditions
Study Description
Brief Summary: The aim of this present study is to investigate the use of benralizumab as treatment for severe nasal polyposis. The effect of benralizumab on nasal polyps will be assessed over a 56 weeks of treatment period in patients with severe bilateral nasal polyposis who are still symptomatic despite standard of care therapy, i.e current use of intranasal corticosteroids (INCS) and prior surgery and/or use of systemic corticosteroids. The first 200 patients that complete the 56-week treatment will have a 6 month follow-up (FU) period without dosing.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Research Site, Birmingham, Alabama, United States
Research Site, Fresno, California, United States
Research Site, Huntington Beach, California, United States
Research Site, La Mesa, California, United States
Research Site, Los Angeles, California, United States
Research Site, Los Angeles, California, United States
Research Site, Orange, California, United States
Research Site, Roseville, California, United States
Research Site, Walnut Creek, California, United States
Research Site, Centennial, Colorado, United States
Research Site, Glenwood Springs, Colorado, United States
Research Site, Washington, District of Columbia, United States
Research Site, Lake Mary, Florida, United States
Research Site, Atlanta, Georgia, United States
Research Site, Decatur, Georgia, United States
Research Site, Chicago, Illinois, United States
Research Site, Chicago, Illinois, United States
Research Site, Des Moines, Iowa, United States
Research Site, Kansas City, Kansas, United States
Research Site, Louisville, Kentucky, United States
Research Site, Baltimore, Maryland, United States
Research Site, Boston, Massachusetts, United States
Research Site, Boston, Massachusetts, United States
Research Site, Rochester, Minnesota, United States
Research Site, Lincoln, Nebraska, United States
Research Site, Bronx, New York, United States
Research Site, Hewlett, New York, United States
Research Site, New Windsor, New York, United States
Research Site, New York, New York, United States
Research Site, New York, New York, United States
Research Site, New York, New York, United States
Research Site, New York, New York, United States
Research Site, New York, New York, United States
Research Site, New York, New York, United States
Research Site, Plainview, New York, United States
Research Site, White Plains, New York, United States
Research Site, Charlotte, North Carolina, United States
Research Site, Winston-Salem, North Carolina, United States
Research Site, Oklahoma City, Oklahoma, United States
Research Site, Philadelphia, Pennsylvania, United States
Research Site, Pittsburgh, Pennsylvania, United States
Research Site, Charleston, South Carolina, United States
Research Site, Conroe, Texas, United States
Research Site, Houston, Texas, United States
Research Site, North Logan, Utah, United States
Research Site, Norfolk, Virginia, United States
Research Site, Richmond, Virginia, United States
Research Site, Spokane, Washington, United States
Research Site, Graz, , Austria
Research Site, Linz, , Austria
Research Site, Salzburg, , Austria
Research Site, St. Pölten, , Austria
Research Site, Wien, , Austria
Research Site, Bruxelles, , Belgium
Research Site, Gent, , Belgium
Research Site, Leuven, , Belgium
Research Site, Vancouver, British Columbia, Canada
Research Site, Hamilton, Ontario, Canada
Research Site, London, Ontario, Canada
Research Site, Mississauga, Ontario, Canada
Research Site, Ottawa, Ontario, Canada
Research Site, Montreal, Quebec, Canada
Research Site, Montreal, Quebec, Canada
Research Site, Montreal, Quebec, Canada
Research Site, Trois-Rivières, Quebec, Canada
Research Site, Quebec, , Canada
Research Site, Quebec, , Canada
Research Site, Aalborg, , Denmark
Research Site, Aarhus N, , Denmark
Research Site, Hillerød, , Denmark
Research Site, Hvidovre, , Denmark
Research Site, København NV, , Denmark
Research Site, Køge, , Denmark
Research Site, Næstved, , Denmark
Research Site, Odense C, , Denmark
Research Site, Vejle, , Denmark
Research Site, Aschaffenburg, , Germany
Research Site, Berlin, , Germany
Research Site, Dreieich, , Germany
Research Site, Dresden, , Germany
Research Site, Düsseldorf, , Germany
Research Site, Göttingen, , Germany
Research Site, Heidelberg, , Germany
Research Site, Lübeck, , Germany
Research Site, Münster, , Germany
Research Site, Wiesbaden, , Germany
Research Site, Budapest, , Hungary
Research Site, Budapest, , Hungary
Research Site, Debrecen, , Hungary
Research Site, Eger, , Hungary
Research Site, Nyíregyháza, , Hungary
Research Site, Pécs, , Hungary
Research Site, Veszprém, , Hungary
Research Site, Nadarzyn, , Poland
Research Site, Strzelce Opolskie, , Poland
Research Site, Warszawa, , Poland
Research Site, Wrocław, , Poland
Research Site, Wrocław, , Poland
Research Site, Łódź, , Poland
Contact Details
Name: Claus Bachert, Prof. dr. h.c.
Affiliation: University Hospital Ghent, de Pintelaan 185, 9000 Ghent, Belgium
Role: PRINCIPAL_INVESTIGATOR
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