Efficacy and Safety Study of Mepolizumab Adjunctive Therapy in Subjects With Severe Uncontrolled Refractory Asthma

PHASE3CompletedINTERVENTIONAL
Enrollment

580

Participants

Timeline

Start Date

October 8, 2012

Primary Completion Date

January 1, 2014

Study Completion Date

January 18, 2014

Conditions
Asthma
Interventions
DRUG

Mepolizumab IV

Mepolizumab 75 mg IV will be administered every 4 weeks with the last dose at Week 28

DRUG

Mepolizumab SC

Mepolizumab 100 mg SC will be administered every 4 weeks with the last dose at Week 28

DRUG

IV Placebo

Normal saline (placebo) will be administered IV every 4 weeks with the last dose at Week 28

DRUG

SC Placebo

Normal saline (placebo) will be administered SC every 4 weeks with the last dose at Week 28

Trial Locations (134)

1020

GSK Investigational Site, Brussels

2305

GSK Investigational Site, New Lambton

3000

GSK Investigational Site, Leuven

3052

GSK Investigational Site, Parkville

3168

GSK Investigational Site, Clayton

4000

GSK Investigational Site, Liège

5042

GSK Investigational Site, Bedford Park

5500

GSK Investigational Site, Mendoza

5600

GSK Investigational Site, San Rafael

6009

GSK Investigational Site, Nedlands

7600

GSK Investigational Site, Mar del Plata

9000

GSK Investigational Site, Ghent

10029

GSK Investigational Site, New York

10367

GSK Investigational Site, Berlin

13915

GSK Investigational Site, Marseille

14050

GSK Investigational Site, México DF

14478

GSK Investigational Site, Potsdam

14642

GSK Investigational Site, Rochester

15562

GSK Investigational Site, Rüdersdorf

16132

GSK Investigational Site, Genoa

17027

GSK Investigational Site, Pietra Ligure (SV)

17033

GSK Investigational Site, Hershey

21018

GSK Investigational Site, Vinnytsia

21224

GSK Investigational Site, Baltimore

22299

GSK Investigational Site, Hamburg

27103

GSK Investigational Site, Winston-Salem

27705

GSK Investigational Site, Durham

28223

GSK Investigational Site, Pozuelo de Alarcón/Madrid

31707

GSK Investigational Site, Albany

34295

GSK Investigational Site, Montpellier

35013

GSK Investigational Site, Cittadella PD

35294

GSK Investigational Site, Birmingham

37203

GSK Investigational Site, Nashville

39112

GSK Investigational Site, Magdeburg

43125

GSK Investigational Site, Parma

43221

GSK Investigational Site, Columbus

44195

GSK Investigational Site, Cleveland

45040

GSK Investigational Site, Zapopan

45200

GSK Investigational Site, Zapopan

45229

GSK Investigational Site, Cincinnati

45231

GSK Investigational Site, Cincinnati

54003

GSK Investigational Site, Mykolayiv

55131

GSK Investigational Site, Mainz

55905

GSK Investigational Site, Rochester

56124

GSK Investigational Site, Pisa

59037

GSK Investigational Site, Lille

60389

GSK Investigational Site, Frankfurt am Main

60596

GSK Investigational Site, Frankfurt am Main

60612

GSK Investigational Site, Chicago

61124

GSK Investigational Site, Kharkiv

63263

GSK Investigational Site, Neu-Isenburg

63571

GSK Investigational Site, Gelnhausen

63739

GSK Investigational Site, Aschaffenburg

64020

GSK Investigational Site, Monterrey

66000

GSK Investigational Site, Perpignan

69317

GSK Investigational Site, Lyon

71100

GSK Investigational Site, Foggia

80131

GSK Investigational Site, Napoli

80206

GSK Investigational Site, Denver

90274

GSK Investigational Site, Rolling Hills Estates

92506

GSK Investigational Site, Riverside

92663

GSK Investigational Site, Newport Beach

94275

GSK Investigational Site, Le Kremlin-Bicêtre

97448

GSK Investigational Site, Saint-Pierre

123182

GSK Investigational Site, Moscow

194354

GSK Investigational Site, Saint Petersburg

194356

GSK Investigational Site, Saint Petersburg

454106

GSK Investigational Site, Chelyabinsk

501757

GSK Investigational Site, Donggu Gwangju

2841959

GSK Investigational Site, Rancagua

4270918

GSK Investigational Site, Talcahuano

8380453

GSK Investigational Site, Santiago

06520

GSK Investigational Site, New Haven

84132-2409

GSK Investigational Site, Salt Lake City

B7600FZN

GSK Investigational Site, Mar del Plata

S2000DBS

GSK Investigational Site, Rosario

C1424BSF

GSK Investigational Site, Buenos Aires

C1426ABP

GSK Investigational Site, Buenos Aires

T2N 4Z6

GSK Investigational Site, Calgary

T6G2E1

GSK Investigational Site, Edmonton

V5Z 1M9

GSK Investigational Site, Vancouver

R2H 2A6

GSK Investigational Site, Winnipeg

L7N 3V2

GSK Investigational Site, Burlington

L8N 3Z5

GSK Investigational Site, Hamilton

N8X 5A6

GSK Investigational Site, Windsor

H2W 1T8

GSK Investigational Site, Montreal

H2X 2P4

GSK Investigational Site, Montreal

H4J 1C5

GSK Investigational Site, Montreal

G1V 4G5

GSK Investigational Site, Québec

J6E 2B4

GSK Investigational Site, Saint-Charles-Borromée

G8T 7A1

GSK Investigational Site, Trois-Rivières

06156

GSK Investigational Site, Perugia

296-8602

GSK Investigational Site, Chiba

802-0052

GSK Investigational Site, Fukuoka

811-1394

GSK Investigational Site, Fukuoka

832-0059

GSK Investigational Site, Fukuoka

370-0615

GSK Investigational Site, Gunma

732-0052

GSK Investigational Site, Hiroshima

062-8618

GSK Investigational Site, Hokkaido

070-8644

GSK Investigational Site, Hokkaido

651-0072

GSK Investigational Site, Hyōgo

672-8064

GSK Investigational Site, Hyōgo

319-1113

GSK Investigational Site, Ibaraki

252-0392

GSK Investigational Site, Kanagawa

861-1196

GSK Investigational Site, Kumamoto

515-8544

GSK Investigational Site, Mie

901-2132

GSK Investigational Site, Okinawa

904-2293

GSK Investigational Site, Okinawa

560-8552

GSK Investigational Site, Osaka

596-8501

GSK Investigational Site, Osaka

102-0083

GSK Investigational Site, Tokyo

103-0027

GSK Investigational Site, Tokyo

171-0014

GSK Investigational Site, Tokyo

187-0024

GSK Investigational Site, Tokyo

431-070

GSK Investigational Site, Anyang-si

420-767

GSK Investigational Site, Bucheon-si

361-711

GSK Investigational Site, Cheongju, Chungcheongbuk-do

705-717

GSK Investigational Site, Daegu

405-760

GSK Investigational Site, Incheon

561-712

GSK Investigational Site, Jeonju-si, Jeollabuk-Do

220-701

GSK Investigational Site, Kangwon-do

120-752

GSK Investigational Site, Seoul

Unknown

GSK Investigational Site, Seoul

443-721

GSK Investigational Site, Suwon, Kyonggi-do

03004

GSK Investigational Site, Alicante

08036

GSK Investigational Site, Barcelona

08041

GSK Investigational Site, Barcelona

08208

GSK Investigational Site, Barcelona

03680

GSK Investigational Site, Kiev

BD9 6RJ

GSK Investigational Site, Bradford

G11 6NT

GSK Investigational Site, Glasgow

EC1M 6BQ

GSK Investigational Site, London

PL6 8DH

GSK Investigational Site, Plymouth

SO16 6YD

GSK Investigational Site, Southampton

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY

NCT01691521 - Efficacy and Safety Study of Mepolizumab Adjunctive Therapy in Subjects With Severe Uncontrolled Refractory Asthma | Biotech Hunter | Biotech Hunter