NCT03610516 - Safety, Pharmacokinetics and Preliminary Efficacy Study of CFZ533 in Patients With Lupus Nephritis. | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

September 12, 2018

Primary Completion Date

June 29, 2023

Study Completion Date

June 29, 2023

Conditions

Lupus Nephritis

Interventions

DRUG

CFZ533

Multiple doses of 10 mg/kg CFZ533 intravenous (IV) infusion. CFZ533 was administered every 4 weeks (Q4W; from Day 1 to Day 141), plus an additional dose of 10 mg/kg IV at Day 15, resulting in a Q2W loading regimen up to the third dose on Day 29.

DRUG

Placebo

multiple doses of placebo intravenous infusion

Trial Locations (21)

1008

Novartis Investigative Site, Tunis

4032

Novartis Investigative Site, Debrecen

10048

Novartis Investigative Site, Taipei

40447

Novartis Investigative Site, Taichung

40705

Novartis Investigative Site, Taichung

41380

Novartis Investigative Site, Kocaeli

55131

Novartis Investigative Site, Mainz

100730

Novartis Investigative Site, Beijing

150062

Novartis Investigative Site, Yaroslavl

197022

Novartis Investigative Site, Saint Petersburg

197110

Novartis Investigative Site, Saint Petersburg

200127

Novartis Investigative Site, Shanghai

344022

Novartis Investigative Site, Rostov-on-Don

410008

Novartis Investigative Site, Changsha

510000

Novartis Investigative Site, Guangzhou

830001

Novartis Investigative Site, Ürümqi

C1015ABO

Novartis Investigative Site, Ciudad Autonoma de Bs As

X5016KEH

Novartis Investigative Site, Córdoba

Unknown

Novartis Investigative Site, Hong Kong

06591

Novartis Investigative Site, Seoul

03080

Novartis Investigative Site, Seoul