Efficacy and Safety Study of Mepolizumab Adjunctive Therapy in Participants With Severe Eosinophilic Asthma on Markers of Asthma Control

PHASE3CompletedINTERVENTIONAL
Enrollment

556

Participants

Timeline

Start Date

December 11, 2014

Primary Completion Date

June 10, 2016

Study Completion Date

June 10, 2016

Conditions
Asthma
Interventions
BIOLOGICAL

Mepolizumab

Humanised Immunoglobulin G (IgG) antibody (IgG1, kappa) with human heavy and light chain frameworks, provided as a lyophilised cake in sterile vial. Vial to be reconstituted with sterile water for injection, just prior to use

DRUG

Placebo

Sterile 0.9% sodium chloride solution

DRUG

SOC

Standard of Care (SOC) will differ by participants, however it will include high dose ICS with at least one other controller, e.g. LABA, with or without maintenance OCS

Trial Locations (144)

1000

GSK Investigational Site, Brussels

1431

GSK Investigational Site, Sofia

1900

GSK Investigational Site, La Plata

2000

GSK Investigational Site, Rosario

3000

GSK Investigational Site, Leuven

3260

GSK Investigational Site, Concepción del Uruguay

4000

GSK Investigational Site, Liège

4011

GSK Investigational Site, Stavanger

5021

GSK Investigational Site, Bergen

5101

GSK Investigational Site, Erpent

5500

GSK Investigational Site, Mendoza

5600

GSK Investigational Site, San Rafael

5800

GSK Investigational Site, Pleven

7006

GSK Investigational Site, Trondheim

7600

GSK Investigational Site, Mar del Plata

9000

GSK Investigational Site, Ghent

10717

GSK Investigational Site, Berlin

11527

GSK Investigational Site, Athens

12157

GSK Investigational Site, Berlin

12203

GSK Investigational Site, Berlin

13419

GSK Investigational Site, Tallinn

13619

GSK Investigational Site, Tallinn

13915

GSK Investigational Site, Marseille

14642

GSK Investigational Site, Rochester

15706

GSK Investigational Site, Santiago de Compostela

19013

GSK Investigational Site, Upland

20354

GSK Investigational Site, Hamburg

21018

GSK Investigational Site, Vinnytsia

21029

GSK Investigational Site, Vinnytsia

21079

GSK Investigational Site, Dijon

21236

GSK Investigational Site, Baltimore

22299

GSK Investigational Site, Hamburg

23188

GSK Investigational Site, Williamsburg

23229

GSK Investigational Site, Richmond

24837

GSK Investigational Site, Schleswig

27705

GSK Investigational Site, Durham

28041

GSK Investigational Site, Madrid

28054

GSK Investigational Site, Gastonia

28223

GSK Investigational Site, Pozuelo de Alarcón/Madrid

28922

GSK Investigational Site, Alcorcón (Madrid)

29118

GSK Investigational Site, Orangeburg

29609

GSK Investigational Site, Brest

32825

GSK Investigational Site, Orlando

33180

GSK Investigational Site, Aventura

33604

GSK Investigational Site, Pessac

34295

GSK Investigational Site, Montpellier

35243

GSK Investigational Site, Birmingham

35294

GSK Investigational Site, Birmingham

39008

GSK Investigational Site, Santander

42100

GSK Investigational Site, Reggio Emilia

43100

GSK Investigational Site, Parma

44093

GSK Investigational Site, Nantes

45231

GSK Investigational Site, Cincinnati

46026

GSK Investigational Site, Valencia

49074

GSK Investigational Site, Dnipro

50134

GSK Investigational Site, Florence

51014

GSK Investigational Site, Tartu

51092

GSK Investigational Site, Reims

55905

GSK Investigational Site, Rochester

56068

GSK Investigational Site, Koblenz

56124

GSK Investigational Site, Pisa

56403

GSK Investigational Site, Thessaloniki

56429

GSK Investigational Site, Thessaloniki

57010

GSK Investigational Site, Thessaloniki

57702

GSK Investigational Site, Rapid City

58452

GSK Investigational Site, Witten

59037

GSK Investigational Site, Lille

61093

GSK Investigational Site, Kharkiv

61124

GSK Investigational Site, Kharkiv

65025

GSK Investigational Site, Odesa

66100

GSK Investigational Site, Chieti

69076

GSK Investigational Site, Zaporizhia

69317

GSK Investigational Site, Lyon

70124

GSK Investigational Site, Bari

71100

GSK Investigational Site, Foggia

74100

GSK Investigational Site, Rethymnon, Crete

75877

GSK Investigational Site, Paris

80206

GSK Investigational Site, Denver

80539

GSK Investigational Site, Munich

84132

GSK Investigational Site, Salt Lake City

90274

GSK Investigational Site, Rolling Hills Estates

90808

GSK Investigational Site, Long Beach

91786

GSK Investigational Site, Upland

92506

GSK Investigational Site, Riverside

92663

GSK Investigational Site, Newport Beach

93720

GSK Investigational Site, Fresno

96049

GSK Investigational Site, Bamberg

115211

GSK Investigational Site, Moscow

195030

GSK Investigational Site, Saint Petesburg

197706

GSK Investigational Site, Sestroretsk

198216

GSK Investigational Site, Saint Petersburg

355030

GSK Investigational Site, Stavropol

394066

GSK Investigational Site, Voronezh

620109

GSK Investigational Site, Yekaterinburg

630102

GSK Investigational Site, Novosibirsk

664043

GSK Investigational Site, Irkutsk

06520

GSK Investigational Site, New Haven

C1121ABE

GSK Investigational Site, Buenos Aires

C1425BEN

GSK Investigational Site, Buenos Aires

T2N 4Z6

GSK Investigational Site, Calgary

V5Z 1M9

GSK Investigational Site, Vancouver

R2H 2A6

GSK Investigational Site, Winnipeg

L7N 3V2

GSK Investigational Site, Burlington

J6E 2B4

GSK Investigational Site, St-Charles-Borromée

M5T 3A9

GSK Investigational Site, Toronto

N8X 5A6

GSK Investigational Site, Windsor

H4J 1C5

GSK Investigational Site, Montreal

G1V 4G5

GSK Investigational Site, Sainte-Foy

G8T 7A1

GSK Investigational Site, Trois-Rivières

625 00

GSK Investigational Site, Brno

748 01

GSK Investigational Site, Hlučín

500 05

GSK Investigational Site, Hradec Králové

278 01

GSK Investigational Site, Kralupy nad Vltavou

775 20

GSK Investigational Site, Olomouc

305 99

GSK Investigational Site, Pilsen

140 59

GSK Investigational Site, Prague

04103

GSK Investigational Site, Leipzig

04357

GSK Investigational Site, Leipzig

106 76

GSK Investigational Site, Athens

124 62

GSK Investigational Site, Haidari / Athens

1105 AZ

GSK Investigational Site, Amsterdam

4818 CK

GSK Investigational Site, Breda

8934 AD

GSK Investigational Site, Leeuwarden

2333 ZA

GSK Investigational Site, Leiden

3045 PM

GSK Investigational Site, Rotterdam

0405

GSK Investigational Site, Oslo

Lima 27

GSK Investigational Site, Lima

Lima 31

GSK Investigational Site, San Martín de Porres

Lima 32

GSK Investigational Site, San Miguel

GSK Investigational Site, Lima

Lima 1

GSK Investigational Site, Lima

972 01

GSK Investigational Site, Bojnice

052 01

GSK Investigational Site, Spišská Nová Ves

927 01

GSK Investigational Site, Šaľa

952 01

GSK Investigational Site, Vráble

03004

GSK Investigational Site, Alicante

08041

GSK Investigational Site, Barcelona

03038

GSK Investigational Site, Kyiv

03049

GSK Investigational Site, Kyiv

03680

GSK Investigational Site, Kyiv

BD9 6RJ

GSK Investigational Site, Bradford

OX3 7LE

GSK Investigational Site, Oxford

PL6 8DH

GSK Investigational Site, Plymouth

SA2 8PP

GSK Investigational Site, Swansea

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY

NCT02281318 - Efficacy and Safety Study of Mepolizumab Adjunctive Therapy in Participants With Severe Eosinophilic Asthma on Markers of Asthma Control | Biotech Hunter | Biotech Hunter