NCT01777256 - An Adaptive Phase II Study to Evaluate the Efficacy, Pharmacodynamics, Safety and Tolerability of GSK2586184 | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

March 1, 2013

Primary Completion Date

March 1, 2014

Study Completion Date

March 31, 2014

Conditions

Systemic Lupus Erythematosus

Interventions

DRUG

GSK2586184 50 mg

GSK2586184 tablet will be administered orally as twice daily dose of 50 mg (1 x 50 mg tablet) up to 12 weeks.

DRUG

GSK2586184 100 mg

GSK2586184 tablet will be administered orally as twice daily dose of (2 X 50 mg tablet) up to 12 weeks.

DRUG

GSK2586184 200 mg

GSK2586184 tablet will be administered orally as twice daily dose of 200 mg (1 x 200 mg) up to 12 weeks.

DRUG

GSK2586184 400 mg

GSK2586184 tablet will be administered orally as twice daily dose of (2 X 200 mg) up to 12 weeks.

DRUG

Placebo

Matching placebo tablet will be administered orally twice daily up to 12 weeks.

Trial Locations (53)

1023

GSK Investigational Site, Budapest

1097

GSK Investigational Site, Budapest

2000

GSK Investigational Site, Rosario

4032

GSK Investigational Site, Debrecen

7405

GSK Investigational Site, Pinelands, Cape Town

7505

GSK Investigational Site, Parow

7600

GSK Investigational Site, Stellenbosch

7925

GSK Investigational Site, Cape Town

8900

GSK Investigational Site, Zalaegerszeg

11172

GSK Investigational Site, Bucharest

11312

GSK Investigational Site, Tallinn

12850

GSK Investigational Site, Prague

13419

GSK Investigational Site, Tallinn

15706

GSK Investigational Site, Santiago de Compostela

24105

GSK Investigational Site, Kiel

28046

GSK Investigational Site, Madrid

29609

GSK Investigational Site, Brest

33604

GSK Investigational Site, Pessac

41013

GSK Investigational Site, Seville

41110

GSK Investigational Site, Larissa

44652

GSK Investigational Site, Herne

50937

GSK Investigational Site, Cologne

55131

GSK Investigational Site, Mainz

59037

GSK Investigational Site, Lille

71110

GSK Investigational Site, Heraklion-Crete

75651

GSK Investigational Site, Paris

87042

GSK Investigational Site, Limoges

400006

GSK Investigational Site, Cluj-Napoca

C1431FWO

GSK Investigational Site, Ciudad de Buenos Aires

J5402DIL

GSK Investigational Site, San Juan

Unknown

GSK Investigational Site, Santiago

GSK Investigational Site, Hong Kong

GSK Investigational Site, Shatin

GSK Investigational Site, Tuenmen

GSK Investigational Site, San Borja

GSK Investigational Site, Surco

775 20

GSK Investigational Site, Olomouc

07747

GSK Investigational Site, Jena

115 21

GSK Investigational Site, Athens

546 42

GSK Investigational Site, Thessaloniki

Lima 13

GSK Investigational Site, La Victoria

Lima 27

GSK Investigational Site, Lima

15-297

GSK Investigational Site, Bialystok

81-384

GSK Investigational Site, Gdynia

20-954

GSK Investigational Site, Lublin

60-856

GSK Investigational Site, Poznan

61-397

GSK Investigational Site, Poznan

020125

GSK Investigational Site, Bucharest

120-752

GSK Investigational Site, Seoul

137-701

GSK Investigational Site, Seoul

143-729

GSK Investigational Site, Seoul

SE-413 45

GSK Investigational Site, Gothenburg

SE-581 85

GSK Investigational Site, Linköping