Efficacy and Safety Study of Sirukumab in Patients With Giant Cell Arteritis

PHASE3TerminatedINTERVENTIONAL
Enrollment

161

Participants

Timeline

Start Date

October 16, 2015

Primary Completion Date

March 21, 2018

Study Completion Date

March 21, 2018

Conditions
Giant Cell Arteritis
Interventions
DRUG

Sirukumab

Sirukumab will be provided as 1 millilitre (mL) Pre-filled Syringe (PFS), containing 100 mg/mL or 50 mg/mL of sirukuma, fitted with a spring-powered, disposable autoinjector device for single use SC administration of liquid biologic drug.

DRUG

Placebo to match sirukumab

Placebo to match sirukumab will be provided as 1.0 mL PFS fitted with a spring-powered, disposable autoinjector device for single use SC administration of liquid biologic drug.

DRUG

Prednisone

Prednisone will be provided as tablets with dosage level up to-60 mg/day. The prednisone dose for all subjects will be determined by the Investigator and starting doses will be within 20-60 mg prednisone at Baseline (Randomization).

DRUG

Placebo to match prednisone

Placebo to match prednisone will be provided as tablets.

Trial Locations (63)

1097

GSK Investigational Site, Budapest

1612

GSK Investigational Site, Sofia

2050

GSK Investigational Site, Camperdown

2217

GSK Investigational Site, Kogarah

3000

GSK Investigational Site, Leuven

3084

GSK Investigational Site, Heidelberg

3145

GSK Investigational Site, Malvern East

3240

GSK Investigational Site, Hamilton

4000

GSK Investigational Site, Liège

4001

GSK Investigational Site, Plovdiv

4032

GSK Investigational Site, Debrecen

5011

GSK Investigational Site, Woodville

6100

GSK Investigational Site, Victoria Park

7910

GSK Investigational Site, Timaru

10021

GSK Investigational Site, New York

13125

GSK Investigational Site, Berlin

14059

GSK Investigational Site, Berlin

15006

GSK Investigational Site, A Coruña

19104

GSK Investigational Site, Philadelphia

20089

GSK Investigational Site, Rozzano

20132

GSK Investigational Site, Milan

22763

GSK Investigational Site, Hamburg

30625

GSK Investigational Site, Hanover

33486

GSK Investigational Site, Boca Raton

34102

GSK Investigational Site, Naples

38305

GSK Investigational Site, Jackson

38320

GSK Investigational Site, San Cristóbal de La Laguna

40225

GSK Investigational Site, Düsseldorf

42100

GSK Investigational Site, Reggio Emilia

45067

GSK Investigational Site, Orléans

48013

GSK Investigational Site, Bilbao

52242

GSK Investigational Site, Iowa City

55905

GSK Investigational Site, Rochester

72076

GSK Investigational Site, Tübingen

73230

GSK Investigational Site, Kirchheim unter Teck

75018

GSK Investigational Site, Paris

75231

GSK Investigational Site, Dallas

75679

GSK Investigational Site, Paris

80210

GSK Investigational Site, Aurora

80336

GSK Investigational Site, München

93009

GSK Investigational Site, Bobigny

93077

GSK Investigational Site, Bad Abbach

98101

GSK Investigational Site, Seattle

98664

GSK Investigational Site, Vancouver

02111

GSK Investigational Site, Boston

02114

GSK Investigational Site, Boston

01307

GSK Investigational Site, Dresden

07747

GSK Investigational Site, Jena

7609 PP

GSK Investigational Site, Almelo

9713 GZ

GSK Investigational Site, Groningen

6525 GA

GSK Investigational Site, Nijmegen

31-121

GSK Investigational Site, Krakow

08036

GSK Investigational Site, Barcelona

08208

GSK Investigational Site, Barcelona

08907

GSK Investigational Site, Barcelona

SS0 0RY

GSK Investigational Site, Westcliff-on-Sea

CH49 9PE

GSK Investigational Site, Metropolitan Borough of Wirral

IP33 2QZ

GSK Investigational Site, Bury St Edmunds

S10 2JF

GSK Investigational Site, Sheffield

EH4 2XR

GSK Investigational Site, Edinburgh

LS9 7TF

GSK Investigational Site, Leeds

OX3 7LD

GSK Investigational Site, Oxford

RG1 5AN

GSK Investigational Site, Reading

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY