A Study of the Safety and Effectiveness of Benralizumab to Treat Patients With Severe Uncontrolled Asthma.

PHASE3CompletedINTERVENTIONAL
Enrollment

660

Participants

Timeline

Start Date

July 7, 2017

Primary Completion Date

September 25, 2019

Study Completion Date

October 21, 2020

Conditions
Asthma
Interventions
DRUG

Benralizumab (Medi-563)

30mg Benralizumab administered as a subcutaneous injection at Visit 4 (day 0), Visit 6 (day 28 +/- 3 days), Visit 7 (day 56 +/- 3 days) and Visit 9 (day 112 +/- 3 days) In the open label ANDHI IP sub study, all patients will receive benralizumab subcutaneously at Day 168 (Week 24), Day 196 (Week 28), Day 224 (Week 32), Day 280 (Week 40), Day 336 (Week 48), Day 392 (Week 56), Day 448 (Week 64), and Day 504 (Week 72).

DRUG

Placebo

Placebo administered as a subcutaneous injection at Visit 4 (day 0), Visit 6 (day 28 +/- 3 days), Visit 7 (day 56 +/- 3 days) and Visit 9 (day 112 +/- 3 days)

Trial Locations (213)

1130

Research Site, Vienna

4000

Research Site, Liège

5000

Research Site, Odense C

5021

Research Site, Bergen

5101

Research Site, Namur

6110

Research Site, Montigny-le-Tilleul

7100

Research Site, Vejle

8200

Research Site, Aarhus N

10016

Research Site, New York

10305

Research Site, Staten Island

10310

Research Site, Staten Island

10459

Research Site, The Bronx

11042

Research Site, New Hyde Park

11407

Research Site, Jerez de la Frontera

13015

Research Site, Marseille

14059

Research Site, Berlin

14618

Research Site, Rochester

15213

Research Site, Pittsburgh

15241

Research Site, Pittsburgh

15562

Research Site, Rüdersdorf

15706

Research Site, Santiago de Compostela

17027

Research Site, Pietra Ligure

19107

Research Site, Philadelphia

19610

Research Site, Reading

20024

Research Site, Garbagnate Milanese

20089

Research Site, Rozzano

20122

Research Site, Milan

20157

Research Site, Milan

20354

Research Site, Hamburg

20520

Research Site, Turku

20815

Research Site, Chevy Chase

21079

Research Site, Dijon

21162

Research Site, White Marsh

22030

Research Site, Fairfax

23188

Research Site, Williamsburg

23225

Research Site, North Chesterfield

23758

Research Site, Oldenburg

24210

Research Site, Abingdon

25030

Research Site, Besançon

25123

Research Site, Brescia

27100

Research Site, Pavia

27103

Research Site, Winston-Salem

27157

Research Site, Winston-Salem

27262

Research Site, High Point

27834

Research Site, Greenville

27909

Research Site, Elizabeth City

28031

Research Site, Madrid

28034

Research Site, Madrid

28054

Research Site, Gastonia

28223

Research Site, Pozuelo de Alarcón

28277

Research Site, Charlotte

28342

Research Site, Valdemoro

29100

Research Site, Piacenza

29340

Research Site, Gaffney

29607

Research Site, Greenville

29609

Research Site, Brest

29615

Research Site, Greenville

29621

Research Site, Anderson

29631

Research Site, Benalmádena

29730

Research Site, Málaga

29732

Research Site, Rock Hill

30625

Research Site, Marburg

31059

Research Site, Toulouse

31406

Research Site, Savannah

31707

Research Site, Albany

32099

Research Site, Jacksonville

32789

Research Site, Winter Park

33126

Research Site, Miami

33173

Research Site, Miami

33604

Research Site, Pessac

33765

Research Site, Clearwater

34090

Research Site, Montpellier

34741

Research Site, Kissimmee

35128

Research Site, Padua

35209

Research Site, Birmingham

37007

Research Site, Salamanca

37045

Research Site, Legnago

37067

Research Site, Franklin

37126

Research Site, Verona

38043

Research Site, Grenoble

38108

Research Site, Taco

39770

Research Site, Laredo

41009

Research Site, Seville

41017

Research Site, Lakeside Park

41124

Research Site, Modena

42123

Research Site, Reggio Emilia

42301

Research Site, Owensboro

43123

Research Site, Grove City

44093

Research Site, Nantes

44124

Research Site, Cona

44789

Research Site, Bochum

45231

Research Site, Cincinnati

45239

Research Site, Essen

45242

Research Site, Cincinnati

46617

Research Site, South Bend

48109

Research Site, Ann Arbor

48197

Research Site, Ypsilanti

48431

Research Site, Rheine

50266

Research Site, West Des Moines

51092

Research Site, Reims

52242

Research Site, Iowa City

53105

Research Site, Bonn

53226

Research Site, Milwaukee

53227

Research Site, West Allis

53228

Research Site, Milwaukee

53792

Research Site, Madison

54511

Research Site, Vandœuvre-lès-Nancy

55402

Research Site, Minneapolis

57108

Research Site, Sioux Falls

59037

Research Site, Lille

59808

Research Site, Missoula

61602

Research Site, Peoria

63156

Research Site, St Louis

64100

Research Site, Bayonne

67091

Research Site, Strasbourg

68510

Research Site, Lincoln

69317

Research Site, Lyon

71100

Research Site, Foggia

71106

Research Site, Shreveport

72209

Research Site, Little Rock

73034

Research Site, Edmond

74136

Research Site, Tulsa

75069

Research Site, McKinney

75225

Research Site, Dallas

75246

Research Site, Dallas

75877

Research Site, Paris

76031

Research Site, Rouen

76109

Research Site, Fort Worth

77429

Research Site, Cypress

77555

Research Site, Galveston

78229

Research Site, San Antonio

78249

Research Site, San Antonio

78251

Research Site, San Antonio

80045

Research Site, Aurora

80131

Research Site, Napoli

84604

Research Site, Provo

85724

Research Site, Tucson

85925

Research Site, La Roche-sur-Yon

87106

Research Site, Albuquerque

88100

Research Site, Catanzaro

88239

Research Site, Wangen

90025

Research Site, Los Angeles

90127

Research Site, Palermo

90806

Research Site, Long Beach

92024

Research Site, Encinitas

92108

Research Site, San Diego

92506

Research Site, Riverside

92663

Research Site, Newport Beach

92691

Research Site, Mission Viejo

93053

Research Site, Regensburg

93301

Research Site, Bakersfield

94270

Research Site, Le Kremlin-Bicêtre

94598

Research Site, Walnut Creek

95123

Research Site, Catania

95207

Research Site, Stockton

98208

Research Site, Everett

98405

Research Site, Tacoma

99204

Research Site, Spokane

06519

Research Site, New Haven

06708

Research Site, Waterbury

02747

Research Site, North Dartmouth

08904

Research Site, Highland Park

08053

Research Site, Marlton

08225

Research Site, Northfield

08854

Research Site, Piscataway

08755

Research Site, Toms River

07044

Research Site, Verona

97015-5737

Research Site, Clackamas

29420-4211

Research Site, North Charleston

05403

Research Site, South Burlington

A-8330

Research Site, Feldbach

T2N 4Z6

Research Site, Calgary

V1W 1V3

Research Site, Kelowna

V5Z 1M9

Research Site, Vancouver

V6Z 1Y6

Research Site, Vancouver

R2H 2A6

Research Site, Winnipeg

L1S 2J5

Research Site, Ajax

L7N 3V2

Research Site, Burlington

L5A 3V4

Research Site, Mississauga

M5T 3A9

Research Site, Toronto

H4A 3J1

Research Site, Montreal

G1V 4W2

Research Site, Québec

00290

Research Site, Helsinki

06002

Research Site, Nice

02321

Research Site, Saint-Quentin

03050

Research Site, Cottbus

07747

Research Site, Jena

Unknown

Research Site, Matera

00168

Research Site, Roma

3813 TZ

Research Site, Amersfoort

7416 SE

Research Site, Deventer

7513 ER

Research Site, Enschede

3844 DG

Research Site, Harderwijk

5707 HA

Research Site, Helmond

6532 SZ

Research Site, Nijmegen

8025 AB

Research Site, Zwolle

N-1478

Research Site, Lørenskog

08916

Research Site, Badalona(Barcelona)

08035

Research Site, Barcelona

08036

Research Site, Barcelona

07010

Research Site, Palma de Mallorca

08208

Research Site, Sabadell

221 85

Research Site, Lund

831 83

Research Site, Östersund

SE-181 58

Research Site, Stockholm

B9 5SS

Research Site, Birmingham

BND9 6RJ

Research Site, Bradford

CB2 2QQ

Research Site, Cambridge

KT16 0PZ

Research Site, Chertsey

DD1 9SY

Research Site, Dundee

G51 4TF

Research Site, Glasgow

EC1A 7BE

Research Site, London

NG5 1PB

Research Site, Nottingham

Sponsors

Lead Sponsor

All Listed Sponsors
lead

AstraZeneca

INDUSTRY