Study to Demonstrate the Efficacy, Safety and Tolerability of an Intravenous Regimen of Secukinumab Compared to Placebo in Subjects With Active axSpA

PHASE3CompletedINTERVENTIONAL
Enrollment

527

Participants

Timeline

Start Date

December 11, 2019

Primary Completion Date

February 17, 2022

Study Completion Date

December 20, 2022

Conditions
Ankylosing Spondylitis
Interventions
DRUG

Secukinumab

The subjects will receive secukinumab 6 mg/kg i.v. at randomization (Baseline (BSL) visit), followed by the administration of secukinumab 3 mg/kg i.v. every four weeks starting at Week 4 through Week 48 (exposure through Week 52)

DRUG

Placebo

The subjects will receive i.v. placebo at randomization (BSL visit), Weeks 4, 8, and 12 , followed by the administration of secukinumab 3 mg/kg i.v. at Week 16 and every four weeks through Week 48 (exposure through Week 52)

Trial Locations (102)

1008

Novartis Investigative Site, Manila

1070

Novartis Investigative Site, Brussels

1102

Novartis Investigative Site, Quezon

1413

Novartis Investigative Site, Sofia

1431

Novartis Investigative Site, Sofia

3000

Novartis Investigative Site, Leuven

4000

Novartis Investigative Site, Plovdiv

4002

Novartis Investigative Site, Plovdiv

4114

Novartis Investigative Site, Dasmariñas

4217

Novartis Investigative Site, Lipa City

5800

Novartis Investigative Site, Pleven

10400

Novartis Investigative Site, Bangkok

10700

Novartis Investigative Site, Bangkoknoi

13676

Novartis Investigative Site, Potsdam

16635

Novartis Investigative Site, Duncansville

21740

Novartis Investigative Site, Cumberland

25801

Novartis Investigative Site, Beckley

26443

Novartis Investigative Site, Pátrai

27408

Novartis Investigative Site, Greensboro

29204

Novartis Investigative Site, Columbia

30450

Novartis Investigative Site, Ipoh

32789

Novartis Investigative Site, Winter Park

33324

Novartis Investigative Site, Plantation

34093

Novartis Investigative Site, Istanbul

34761

Novartis Investigative Site, Ocoee

37134

Novartis Investigative Site, Verona

38119

Novartis Investigative Site, Memphis

38305

Novartis Investigative Site, Jackson

40002

Novartis Investigative Site, Khon Kaen

42101

Novartis Investigative Site, Bowling Green

44130

Novartis Investigative Site, Middleburg Heights

48439

Novartis Investigative Site, Grand Blanc

53100

Novartis Investigative Site, Siena

59100

Novartis Investigative Site, Kuala Lumpur

61469

Novartis Investigative Site, Gwangju

68100

Novartis Investigative Site, Selangor Darul Ehsan

68516

Novartis Investigative Site, Lincoln

70300

Novartis Investigative Site, Seremban

77380

Novartis Investigative Site, The Woodlands

77382

Novartis Investigative Site, Spring

77494

Novartis Investigative Site, Katy

90110

Novartis Investigative Site, Songkhla

91786

Novartis Investigative Site, Upland

91942

Novartis Investigative Site, La Mesa

92604

Novartis Investigative Site, Irvine

93586

Novartis Investigative Site, Kuching

94578

Novartis Investigative Site, San Leandro

97239

Novartis Investigative Site, Portland

98208

Novartis Investigative Site, Everett

99204

Novartis Investigative Site, Spokane

110029

Novartis Investigative Site, New Delhi

110221

Novartis Investigative Site, Bogotá

111121

Novartis Investigative Site, Cundinamarca

115522

Novartis Investigative Site, Moscow

150003

Novartis Investigative Site, Yaroslavl

185019

Novartis Investigative Site, Petrozavodsk

190068

Novartis Investigative Site, Saint Petersburg

197341

Novartis Investigative Site, Saint Petersburg

395009

Novartis Investigative Site, Surat

420064

Novartis Investigative Site, Kazan'

432063

Novartis Investigative Site, Ulyanovsk

454076

Novartis Investigative Site, Chelyabinsk

500082

Novartis Investigative Site, Hyderabad

620137

Novartis Investigative Site, Yekaterinburg

630047

Novartis Investigative Site, Novosibirsk

630099

Novartis Investigative Site, Novosibirsk

650029

Novartis Investigative Site, Kemerovo

650070

Novartis Investigative Site, Kemerovo

730006

Novartis Investigative Site, Ibagué

29055 450

Novartis Investigative Site, Vitória

40150 150

Novartis Investigative Site, Salvador

36010 570

Novartis Investigative Site, Juiz de Fora

01244-030

Novartis Investigative Site, São Paulo

20241-180

Novartis Investigative Site, Rio de Janeiro

15090 000

Novartis Investigative Site, São José do Rio Preto

080002

Novartis Investigative Site, Barranquilla

0001

Novartis Investigative Site, Bucaramanga

080020

Novartis Investigative Site, Barranquilla

772 00

Novartis Investigative Site, Ostrava

128 50

Novartis Investigative Site, Prague

140 59

Novartis Investigative Site, Prague

150 06

Novartis Investigative Site, Prague

686 01

Novartis Investigative Site, Uherské Hradiště

115 27

Novartis Investigative Site, Athens

01009

Novartis Investigative Site, Guatemala City

01010

Novartis Investigative Site, Guatemala City

01011

Novartis Investigative Site, Guatemala City

560 079

Novartis Investigative Site, Bangalore

400 053

Novartis Investigative Site, Mumbai

422 101

Novartis Investigative Site, Nashik

15-351

Novartis Investigative Site, Bialystok

30 002

Novartis Investigative Site, Krakow

96-500

Novartis Investigative Site, Sochaczew

87-100

Novartis Investigative Site, Torun

02 637

Novartis Investigative Site, Warsaw

04763

Novartis Investigative Site, Seoul

05030

Novartis Investigative Site, Seoul

05278

Novartis Investigative Site, Seoul

182 88

Novartis Investigative Site, Danderyd

171 76

Novartis Investigative Site, Stockholm

01160

Novartis Investigative Site, Adana

06100

Novartis Investigative Site, Ankara

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY