Efficacy and Safety Study of Benralizumab for Patients With Severe Nasal Polyposis

PHASE3CompletedINTERVENTIONAL
Enrollment

413

Participants

Timeline

Start Date

January 15, 2018

Primary Completion Date

July 31, 2020

Study Completion Date

July 31, 2020

Conditions
Nasal Polyposis
Interventions
BIOLOGICAL

Benralizumab 30 mg SC + Mometasone Furoate

"Benralizumab injection is 30mg/ml SC clear to opalescent, colourless to yellow solution in accessorized pre-filled syringe.~Benralizumab 30 mg SC will be injected every 4 weeks for the first 3 doses - Weeks 0 , 4 and 8 and every 8 weeks thereafter - Weeks 16, 24, 32, 40 and 48. Total of 8 doses.~Mometasone Furoate Nasal Spray (MFNS) - intranasal corticosteroid - 2 doses (1 dose = 50 micrograms/actuation) in each nostril twice daily. Total daily dose of 400mcg. MFNS will be used for a minimum of 4 weeks prior to randomization and will be continued throughout the study."

BIOLOGICAL

Matching placebo SC + Mometasone Furoate

"Matching placebo injection is SC clear to opalescent, colourless to yellow solution in accessorized pre-filled syringe.~Matching placebo SC will be injected every 4 weeks for the first 3 doses - Weeks 0 , 4 and 8 and every 8 weeks thereafter - Weeks 16, 24, 32, 40 and 48. Total of 8 doses.~Mometasone Furoate Nasal Spray (MFNS) - intranasal corticosteroid - 2 doses (1 dose = 50 micrograms/actuation) in each nostril twice daily. Total daily dose of 400mcg. MFNS will be used for a minimum of 4 weeks prior to randomization and will be continued throughout the study."

Trial Locations (99)

1083

Research Site, Budapest

1090

Research Site, Vienna

1106

Research Site, Budapest

1200

Research Site, Brussels

2400

Research Site, København NV

2650

Research Site, Hvidovre

3000

Research Site, Leuven

3100

Research Site, Sankt Pölten

3300

Research Site, Eger

3400

Research Site, Hillerød

4010

Research Site, Linz

4032

Research Site, Debrecen

4400

Research Site, Nyíregyháza

4600

Research Site, Køge

4700

Research Site, Næstved

5000

Research Site, Odense C

5020

Research Site, Salzburg

7100

Research Site, Vejle

7621

Research Site, Pécs

8036

Research Site, Graz

8200

Research Site, Aarhus N

Research Site, Veszprém

9000

Research Site, Ghent

Research Site, Aalborg

10001

Research Site, New York

10011

Research Site, New York

10016

Research Site, New York

10022

Research Site, New York

10075

Research Site, New York

10128

Research Site, New York

10461

Research Site, The Bronx

10605

Research Site, White Plains

11557

Research Site, Hewlett

11803

Research Site, Plainview

12553

Research Site, New Windsor

13353

Research Site, Berlin

15213

Research Site, Pittsburgh

19107

Research Site, Philadelphia

20037

Research Site, Washington D.C.

21224

Research Site, Baltimore

23235

Research Site, Richmond

23507

Research Site, Norfolk

23538

Research Site, Lübeck

27103

Research Site, Winston-Salem

28210

Research Site, Charlotte

29425

Research Site, Charleston

30030

Research Site, Decatur

30308

Research Site, Atlanta

32746

Research Site, Lake Mary

35209

Research Site, Birmingham

37073

Research Site, Göttingen

40220

Research Site, Louisville

40225

Research Site, Düsseldorf

48149

Research Site, Münster

50312

Research Site, Des Moines

55905

Research Site, Rochester

60611

Research Site, Chicago

60657

Research Site, Chicago

63303

Research Site, Dreieich

63739

Research Site, Aschaffenburg

65183

Research Site, Wiesbaden

66160

Research Site, Kansas City

68510

Research Site, Lincoln

69120

Research Site, Heidelberg

73120

Research Site, Oklahoma City

77030

Research Site, Houston

77304

Research Site, Conroe

80112

Research Site, Centennial

81601

Research Site, Glenwood Springs

84341

Research Site, North Logan

90048

Research Site, Los Angeles

91942

Research Site, La Mesa

92647

Research Site, Huntington Beach

92868

Research Site, Orange

93720

Research Site, Fresno

94598

Research Site, Walnut Creek

95661

Research Site, Roseville

99201

Research Site, Spokane

90095-1624

Research Site, Los Angeles

02111

Research Site, Boston

02114

Research Site, Boston

V5Z 1M9

Research Site, Vancouver

L8S 1G5

Research Site, Hamilton

N6A 4V2

Research Site, London

L5A 3V4

Research Site, Mississauga

K1G 6C6

Research Site, Ottawa

H2X 3E4

Research Site, Montreal

H3G 1L5

Research Site, Montreal

H4A 3J1

Research Site, Montreal

G1V 4G5

Research Site, Québec

G1V 4W2

Research Site, Québec

G8T 7A1

Research Site, Trois-Rivières

01307

Research Site, Dresden

90-153

Research Site, Lodz

05-830

Research Site, Nadarzyn

47-100

Research Site, Strzelce Opolskie

02-547

Research Site, Warsaw

50-220

Research Site, Wroclaw

53-301

Research Site, Wroclaw

Sponsors

Lead Sponsor

All Listed Sponsors
lead

AstraZeneca

INDUSTRY