Study the Efficacy and Safety of VAY736 and CFZ533 in SLE Patients

PHASE2CompletedINTERVENTIONAL
Enrollment

107

Participants

Timeline

Start Date

December 19, 2018

Primary Completion Date

July 27, 2022

Study Completion Date

April 28, 2025

Conditions
Systemic Lupus Erythematosus (SLE)
Interventions
DRUG

VAY736

150 mg powder in vial for solution for injection; after reconstitution to 150 mg/mL per vial, a dose of 300 mg

DRUG

VAY736 Placebo

solution for injection; 0 mg/mL administered as 2 mL s.c. injection

DRUG

CFZ533

150 mg/mL as concentrate in vial for infusion, administered at a dose of 10 mg/kg as i.v. infusion

DRUG

CFZ533 Placebo

Placebo as concentrate in vial for infusion, administered at a dose of 10 mg/kg as i.v. infusion

Trial Locations (31)

1023

Novartis Investigative Site, Budapest

3168

Novartis Investigative Site, Clayton

4032

Novartis Investigative Site, Debrecen

10117

Novartis Investigative Site, Berlin

10400

Novartis Investigative Site, Bangkok

10700

Novartis Investigative Site, Bangkok

33604

Novartis Investigative Site, Pessac

40201

Novartis Investigative Site, Taichung

40447

Novartis Investigative Site, Taichung

61469

Novartis Investigative Site, Gwangju

79106

Novartis Investigative Site, Freiburg im Breisgau

115522

Novartis Investigative Site, Moscow

194044

Novartis Investigative Site, Saint Petersburg

200127

Novartis Investigative Site, Shanghai

210008

Novartis Investigative Site, Nanjing

407219

Novartis Investigative Site, Taichung

510000

Novartis Investigative Site, Guangzhou

620144

Novartis Investigative Site, Yekaterinburg

5265601

Novartis Investigative Site, Ramat Gan

C1015ABO

Novartis Investigative Site, Ciudad Autonoma de Bs As

128 00

Novartis Investigative Site, Prague

457 8510

Novartis Investigative Site, Nagoya

460-0001

Novartis Investigative Site, Nagoya

104 8560

Novartis Investigative Site, Chuo Ku

162 8655

Novartis Investigative Site, Shinjuku Ku

160 8582

Novartis Investigative Site, Shinjuku-ku

85 168

Novartis Investigative Site, Bydgoszcz

60-218

Novartis Investigative Site, Poznan

00-874

Novartis Investigative Site, Warsaw

08035

Novartis Investigative Site, Barcelona

08041

Novartis Investigative Site, Barcelona

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY