Evaluation of Efficacy and Safety of Sarilumab in Patients With GCA

PHASE3TerminatedINTERVENTIONAL
Enrollment

83

Participants

Timeline

Start Date

November 20, 2018

Primary Completion Date

November 24, 2020

Study Completion Date

November 24, 2020

Conditions
Giant Cell Arteritis
Interventions
DRUG

Sarilumab SAR153191

Pharmaceutical form: solution for injection Route of administration: subcutaneous

DRUG

Sarilumab matching placebo

Pharmaceutical form: solution for injection Route of administration: subcutaneous

DRUG

Prednisone

Pharmaceutical form: tablets or capsules Route of administration: oral administration

DRUG

Prednisone matching placebo

Pharmaceutical form: capsules Route of administration: oral administration

Trial Locations (61)

1000

Investigational Site Number 7050001, Ljubljana

2217

Investigational Site Number 0360001, Kogarah

3000

Investigational Site Number 0560001, Leuven

3124

Investigational Site Number 0360003, Camberwell

3168

Investigational Site Number 0360006, Clayton

4032

Investigational Site Number 3480001, Debrecen

5700

Investigational Site Number 2080003, Svendborg

8000

Investigational Site Number 2080002, Aarhus C

9007

Investigational Site Number 7560002, Sankt Gallen

10000

Investigational Site Number 1910001, Zagreb

13125

Investigational Site Number 2760001, Berlin

13419

Investigational Site Number 2330001, Tallinn

15006

Investigational Site Number 7240011, A Coruña

19104

Investigational Site Number 8400019, Philadelphia

20089

Investigational Site Number 3800005, Rozzano

20132

Investigational Site Number 3800001, Milan

28046

Investigational Site Number 7240014, Madrid

29609

Investigational Site Number 2500005, Brest

32608

Investigational Site Number 8400017, Gainesville

33486

Investigational Site Number 8400002, Boca Raton

33604

Investigational Site Number 2500006, Pessac

34295

Investigational Site Number 2500003, Montpellier

34362

Investigational Site Number 3760004, Haifa

38320

Investigational Site Number 7240015, Santa Cruz de Tenerife

48013

Investigational Site Number 7240010, Bilbao

52242

Investigational Site Number 8400014, Iowa City

68100

Investigational Site Number 2500007, Mulhouse

72076

Investigational Site Number 2760007, Tübingen

73230

Investigational Site Number 2760003, Kirchheim unter Teck

75014

Investigational Site Number 2500001, Paris

75231

Investigational Site Number 8400011, Dallas

76290

Investigational Site Number 2500002, Montivilliers

78278

Investigational Site Number 3760006, Ashkelon

80336

Investigational Site Number 2760004, München

97239

Investigational Site Number 8400018, Portland

115404

Investigational Site Number 6430002, Moscow

123182

Investigational Site Number 6430003, Moscow

650000

Investigational Site Number 6430005, Kemerovo

C1015ABO

Investigational Site Number 0320001, Buenos Aires

C1181ACH

Investigational Site Number 0320002, Caba

L8N 4A6

Investigational Site Number 1240007, Hamilton

H4A 3T2

Investigational Site Number 1240010, Montreal

G5L 5T1

Investigational Site Number 1240001, Rimouski

J1G 2E8

Investigational Site Number 1240005, Sherbrooke

G8Z 1Y2

Investigational Site Number 1240003, Trois-Rivières

01307

Investigational Site Number 2760002, Dresden

8934 AD

Investigational Site Number 5280005, Leeuwarden

6162 BG

Investigational Site Number 5280009, Sittard-Geleen

2545 CH

Investigational Site Number 5280007, The Hague

5912 BL

Investigational Site Number 5280001, Venlo

2801-951

Investigational Site Number 6200001, Almada

3810-501

Investigational Site Number 6200005, Aveiro

4990-041

Investigational Site Number 6200004, Ponte de Lima

08208

Investigational Site Number 7240016, Sabadell

701 85

Investigational Site Number 7520003, Örebro

751 85

Investigational Site Number 7520001, Uppsala

AB25 2ZN

Investigational Site Number 8260006, Aberdeen

NE9 6SX

Investigational Site Number 8260004, Gateshead

LS7 4SA

Investigational Site Number 8260003, Leeds

M13 9WL

Investigational Site Number 8260005, Manchester

PO6 3LY

Investigational Site Number 8260011, Portsmouth

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Regeneron Pharmaceuticals

INDUSTRY

lead

Sanofi

INDUSTRY

NCT03600805 - Evaluation of Efficacy and Safety of Sarilumab in Patients With GCA | Biotech Hunter | Biotech Hunter