Safety, Pharmacokinetics and Preliminary Efficacy Study of CFZ533 in Patients With Primary Sjögren's Syndrome

PHASE2CompletedINTERVENTIONAL
Enrollment

69

Participants

Timeline

Start Date

October 22, 2014

Primary Completion Date

June 29, 2018

Study Completion Date

June 29, 2018

Conditions
Primary Sjögren's Syndrome
Interventions
DRUG

CFZ533 active - Cohort 1

multiple doses of CFZ533 s.c. injection

DRUG

CFZ533 placebo- Cohort 1

multiple doses of placebo s.c. injection

DRUG

CFZ533 active - Cohort 2

multiple doses of CFZ533 intravenous infusion

DRUG

CFZ533 placebo - Cohort 2

multiple doses of placebo intravenous infusion

DRUG

CFZ533 active -Cohort 3

multiple doses of CFZ533 s.c. injection

DRUG

CFZ533 active - Cohort 3

Single dose of CFZ533 i.v. infusion and multiple doses of CFZ533 s.c. injection

Trial Locations (9)

4031

Novartis Investigative Site, Basel

4032

Novartis Investigative Site, Debrecen

10117

Novartis Investigative Site, Berlin

11501

Novartis Investigative Site, Mineola

16635

Novartis Investigative Site, Duncansville

02111

Novartis Investigative Site, Boston

B15 2WB

Novartis Investigative Site, Edgbaston

EC14 7BE

Novartis Investigative Site, London

NE2 4HH

Novartis Investigative Site, Newcastle upon Tyne

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY