A Randomized, Double-blind 2-arm NEPTUNUS Extension Study to Assess the Long-term Safety and Efficacy of Ianalumab in Patients With Sjogrens Syndrome.

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

613

Participants

Timeline

Start Date

October 27, 2023

Primary Completion Date

August 21, 2028

Study Completion Date

July 18, 2030

Conditions
Sjogrens Syndrome
Interventions
DRUG

Ianalumab (VAY736)

Ianalumab 300 mg / 2 mL, PFS or AI, monthly or every 3 months, solution for injection for subcutaneous use

OTHER

Placebo

Placebo 0 mg/2 mL PFS or AI, once monthly between doses of Ianalumab 3 monthly , solution for injection for subcutaneous Use

Trial Locations (196)

1606

Novartis Investigative Site, Sofia

1646

Novartis Investigative Site, Buenos Aires

1878

Novartis Investigative Site, Quilmes

2000

Novartis Investigative Site, Stockerau

3000

Novartis Investigative Site, Leuven

3300

Novartis Investigative Site, Eger

4000

Novartis Investigative Site, San Miguel de Tucumán

4032

Novartis Investigative Site, Debrecen

4558

Novartis Investigative Site, Maroochydore

5011

Novartis Investigative Site, Woodville South

5700

Novartis Investigative Site, Gyula

6720

Novartis Investigative Site, Szeged

6740

Novartis Investigative Site, Concepción

7000

Novartis Investigative Site, Hobart

7500

Novartis Investigative Site, Panorama

7600

Novartis Investigative Site, Stellenbosch

8000

Novartis Investigative Site, Burgas

Novartis Investigative Site, Székesfehérvár

8036

Novartis Investigative Site, Graz

9001

Novartis Investigative Site, Quetzaltenango

11501

Winthrop University Hospital, Mineola

13125

Novartis Investigative Site, Berlin

13353

Novartis Investigative Site, Berlin

13676

St Lawrence Health System, Potsdam

14004

Novartis Investigative Site, Córdoba

15006

Novartis Investigative Site, A Coruña

16635

Altoona Center for Clin Res, Duncansville

20100

Novartis Investigative Site, Milan

21034

Novartis Investigative Site, Dijon

21224

The John Hopkins Jerome L Greene Sjogren, Baltimore

28034

Novartis Investigative Site, Madrid

28202

On Site Clinical Solutions Llc, Charlotte

28207

Arthritis and Osteoporosis, Charlotte

29200

Novartis Investigative Site, Brest

30024

North GA Rheumatology Group PC, Suwanee

30625

Novartis Investigative Site, Hanover

30912

Augusta University Georgia, Augusta

33024

GNP Research, Cooper City

33321

West Broward Rheumatology Associates Inc, Tamarac

33511

Bay Area Arthritis And Osteoporosis, Brandon

34239

Sarasota Arthritis Res Ctr, Sarasota

36200

Novartis Investigative Site, Vigo

38119

Shelby Research LLC, Memphis

38305

West Tennessee Research Institute, Jackson

39008

Novartis Investigative Site, Santander

40447

Novartis Investigative Site, Taichung

41380

Novartis Investigative Site, Kocaeli

42055

Novartis Investigative Site, Saint-Etienne

44649

Novartis Investigative Site, Herne

44650

Novartis Investigative Site, Guadalajara

45402

STAT Research Inc, Dayton

46026

Novartis Investigative Site, Valencia

48013

Novartis Investigative Site, Bilbao

49933

Novartis Investigative Site, Angers

50367

Novartis Investigative Site, Wroclaw

50937

Novartis Investigative Site, Cologne

59037

Novartis Investigative Site, Lille

60126

Novartis Investigative Site, Ancona

60467

Clin Invest Specialists Inc, Orland Park

61469

Novartis Investigative Site, Gwangju

63800

Novartis Investigative Site, Brno

66160

University of Kansas Hospital, Kansas City

67000

Novartis Investigative Site, Strasbourg

67063

Novartis Investigative Site, Ludwigshafen

70809

Ochsner Health System, Baton Rouge

72000

Novartis Investigative Site, Le Mans

73116

RAO Research LLS, Oklahoma City

75010

Novartis Investigative Site, Paris

75013

Novartis Investigative Site, Paris

76034

Precision Comprehensive Research, Colleyville

77030

Baylor College Of Medicine, Houston

77054

Prolato Clinical Research Center, Houston

77382

Advanced Rheumatology of Houston, Spring

77494

Houston Rheumatology & Arthrit, Katy

78229

First Outpatient Research Unit, San Antonio

79106

Novartis Investigative Site, Freiburg im Breisgau

80131

Novartis Investigative Site, Napoli

81108

Novartis Investigative Site, Bratislava

81346

Novartis Investigative Site, Kaohsiung City

83301

Novartis Investigative Site, Kaohsiung City

84100

Novartis Investigative Site, Salerno

88011

Arthritis Osteoporosis Assoc of NM, Las Cruces

90623

Advanced Medical Research, La Palma

91056

Novartis Investigative Site, Erlangen

91405

Medvin Clinical Research, Van Nuys

92835

Providence Medical Foundation, Fullerton

94275

Novartis Investigative Site, Le Kremlin-Bicêtre

97070

Novartis Investigative Site, Mérida

97080

Novartis Investigative Site, Würzburg

99204

Arthritis Northwest PLLC, Spokane

100029

Novartis Investigative Site, Beijing

100050

Novartis Investigative Site, Beijing

100730

Novartis Investigative Site, Beijing

110011

Novartis Investigative Site, Shenyang

110029

Novartis Investigative Site, New Delhi

110221

Novartis Investigative Site, Bogotá

130021

Novartis Investigative Site, Changchun

200011

Novartis Investigative Site, Shanghai

210008

Novartis Investigative Site, Nanjing

230001

Novartis Investigative Site, Hefei

276000

Novartis Investigative Site, Linyi

300052

Novartis Investigative Site, Tianjin

330006

Novartis Investigative Site, Nanchang

337000

Novartis Investigative Site, Pingxiang

380013

Novartis Investigative Site, Ahmedabad

380015

Novartis Investigative Site, Ahmedabad

400006

Novartis Investigative Site, Cluj-Napoca

400010

Novartis Investigative Site, Chongqing

407219

Novartis Investigative Site, Taichung

430030

Novartis Investigative Site, Wuhan

453099

Novartis Investigative Site, Xinxiang

500283

Novartis Investigative Site, Brasov

510630

Novartis Investigative Site, Guangzhou

518020

Novartis Investigative Site, Shenzhen

610041

Novartis Investigative Site, Chengdu

710063

Novartis Investigative Site, Shanxi

750000

Novartis Investigative Site, Yinchuan

4428164

Novartis Investigative Site, Kfar Saba

4710243

Novartis Investigative Site, Braga

5110683

Novartis Investigative Site, Valdivia

5265601

Novartis Investigative Site, Ramat Gan

7500571

Novartis Investigative Site, Santiago

7500588

Novartis Investigative Site, Santiago

7500710

Novartis Investigative Site, Santiago

02111

Tufts School of Dental Medicine, Boston

C1405BCH

Novartis Investigative Site, CABA

C1055AAF

Novartis Investigative Site, Ciudad Autonoma de Bs As

C1428AZF

Novartis Investigative Site, Ciudad Autonoma de Bs As

29055 450

Novartis Investigative Site, Vitória

40150 150

Novartis Investigative Site, Salvador

36010 570

Novartis Investigative Site, Juiz de Fora

14048-900

Novartis Investigative Site, Ribeirão Preto

04266 010

Novartis Investigative Site, São Paulo

01409-902

Novartis Investigative Site, São Paulo

V5Z 1L7

Novartis Investigative Site, Vancouver

B1P 1P3

Novartis Investigative Site, Sydney

G5L 5T1

Novartis Investigative Site, Rimouski

J1G 2E8

Novartis Investigative Site, Sherbrooke

G9A 3Y2

Novartis Investigative Site, Trois-Rivières

014010

Novartis Investigative Site, Baotou

030000

Novartis Investigative Site, Taiyuan

030001

Novartis Investigative Site, Taiyuan

050001

Novartis Investigative Site, Medellín

080002

Novartis Investigative Site, Barranquilla

0001

Novartis Investigative Site, Bucaramanga

686 01

Novartis Investigative Site, Uherské Hradiště

01307

Novartis Investigative Site, Dresden

115 21

Novartis Investigative Site, Athens

115 27

Novartis Investigative Site, Athens

01009

Novartis Investigative Site, Guatemala City

01010

Novartis Investigative Site, Guatemala City

01011

Novartis Investigative Site, Guatemala City

455-8530

Novartis Investigative Site, Nagoya

457 8510

Novartis Investigative Site, Nagoya

457-8511

Novartis Investigative Site, Nagoya

807-8556

Novartis Investigative Site, Kitakyushu

060 8648

Novartis Investigative Site, Sapporo

245-8575

Novartis Investigative Site, Yokohama

511-0061

Novartis Investigative Site, Kuwana

857-1195

Novartis Investigative Site, Sasebo

710-0824

Novartis Investigative Site, Kurashiki

113-8431

Novartis Investigative Site, Bunkyo Ku

104 8560

Novartis Investigative Site, Chuo Ku

173-8610

Novartis Investigative Site, Itabashi-ku

152-8902

Novartis Investigative Site, Meguro-ku

160 8582

Novartis Investigative Site, Shinjuku-ku

08406

Novartis Investigative Site, Vilnius

06700

Novartis Investigative Site, Mexico City

CP 80000

Novartis Investigative Site, Culiacán

07029

Novartis Investigative Site, México

61-397

Novartis Investigative Site, Poznan

30-727

Novartis Investigative Site, Krakow

52 416

Novartis Investigative Site, Wroclaw

52-210

Novartis Investigative Site, Wroclaw

85 168

Novartis Investigative Site, Bydgoszcz

30 002

Novartis Investigative Site, Krakow

00-874

Novartis Investigative Site, Warsaw

6300 858

Novartis Investigative Site, Guarda

1050-034

Novartis Investigative Site, Lisbon

1349-019

Novartis Investigative Site, Lisbon

1649 035

Novartis Investigative Site, Lisbon

011172

Novartis Investigative Site, Bucharest

S308433

Novartis Investigative Site, Singapore

04011

Novartis Investigative Site, Košice

960 01

Novartis Investigative Site, Zvolen

06591

Novartis Investigative Site, Seoul

08208

Novartis Investigative Site, Sabadell

08916

Novartis Investigative Site, Badalona

08041

Novartis Investigative Site, Barcelona

113 65

Novartis Investigative Site, Stockholm

06100

Novartis Investigative Site, Ankara

06230

Novartis Investigative Site, Ankara

06500

Novartis Investigative Site, Ankara

LS1 3EX

Novartis Investigative Site, Leeds

L9 7AL

Novartis Investigative Site, Liverpool

NE1 4LP

Novartis Investigative Site, Newcastle upon Tyne

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY