NCT04541589 - Study of Safety and Tolerability of CFZ533 in Patients With Sjögren's Syndrome | Biotech Hunter

Enrollment

206

Participants

Timeline

Start Date

January 5, 2021

Primary Completion Date

August 19, 2024

Study Completion Date

August 19, 2024

Conditions

Sjogren's Syndrome

Interventions

DRUG

Iscalimab

Iscalimab 600 mg or 300 mg was administered subcutaneously weekly for the first 3 weeks. Subsequently, iscalimab was administered subcutaneously bi-weekly (every other week or Q2W).

OTHER

Placebo

Placebo (1 injection of 2 ml) administered to participants in the iscalimab 300 mg arm to maintain blinding until the final database lock of the core study

Trial Locations (62)

1090

Novartis Investigative Site, Vienna

1426

Novartis Investigative Site, CABA

6009

Novartis Investigative Site, Nedlands

6720

Novartis Investigative Site, Szeged

8000

Novartis Investigative Site, Székesfehérvár

8036

Novartis Investigative Site, Graz

11501

Winthrop University Hospital, Mineola

19104

Perelman School of Medicine, Philadelphia

20132

Novartis Investigative Site, Milan

21224

The John Hopkins Jerome L Greene Sjogren, Baltimore

29200

Novartis Investigative Site, Brest

30024

North GA Rheumatology Group PC, Suwanee

53105

Novartis Investigative Site, Bonn

53792

Uni Wisconsin School Med Pub Health, Madison

56124

Novartis Investigative Site, Pisa

59037

Novartis Investigative Site, Lille

67000

Novartis Investigative Site, Strasbourg

70809

Ochsner Health System, Baton Rouge

79106

Novartis Investigative Site, Freiburg im Breisgau

94275

Novartis Investigative Site, Le Kremlin-Bicêtre

97080

Novartis Investigative Site, Würzburg

115522

Novartis Investigative Site, Moscow

195257

Novartis Investigative Site, Saint Petersburg

400006

Novartis Investigative Site, Cluj-Napoca

420097

Novartis Investigative Site, Kazan'

500283

Novartis Investigative Site, Brasov

620028

Novartis Investigative Site, Yekaterinburg

634009

Novartis Investigative Site, Tomsk

3104802

Novartis Investigative Site, Haifa

4428164

Novartis Investigative Site, Kfar Saba

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

C1055AAF

Novartis Investigative Site, Ciudad Autonoma de Bs As

29055 450

Novartis Investigative Site, Vitória

36010 570

Novartis Investigative Site, Juiz de Fora

01244-030

Novartis Investigative Site, São Paulo

M5T 2S8

Novartis Investigative Site, Toronto

G5L 5T1

Novartis Investigative Site, Rimouski

G9A 3Y2

Novartis Investigative Site, Trois-Rivières

050001

Novartis Investigative Site, Medellín

080002

Novartis Investigative Site, Barranquilla

01307

Novartis Investigative Site, Dresden

115 27

Novartis Investigative Site, Athens

457 8510

Novartis Investigative Site, Nagoya

857-1195

Novartis Investigative Site, Sasebo

710-0824

Novartis Investigative Site, Kurashiki

104 8560

Novartis Investigative Site, Chuo Ku

3015 GD

Novartis Investigative Site, Rotterdam

9713 GZ

Novartis Investigative Site, Groningen

1050-034

Novartis Investigative Site, Lisbon

1649 035

Novartis Investigative Site, Lisbon

4990 041

Novartis Investigative Site, Ponte de Lima

06591

Novartis Investigative Site, Seoul

113 65

Novartis Investigative Site, Stockholm

06500

Novartis Investigative Site, Ankara

B15 2TH

Novartis Investigative Site, Birmingham

DN2 5LT

Novartis Investigative Site, Doncaster

M13 9WL

Novartis Investigative Site, Manchester