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A Placebo-controlled, Patient and Investigator Blinded, Randomized Parallel Cohort Study to Assess Pharmacodynamics, Pharmacokinetics, Safety, Tolerability and Preliminary Clinical Efficacy of VAY736 and CFZ533 in Patients With Systemic Lupus Erythematosus (SLE)
This study is designed to evaluate the safety, tolerability, pharmacokinetics and therapeutic efficacy of treatment with either VAY736 (ianalumab) or CFZ533 (iscalimab) in patients with systemic lupus erythematosus (SLE) to enable further development of these compounds as treatment in this disease population
The study consists of a 28-day screening period, a blinded treatment period of 28 weeks where randomized patients received treatment with investigational drug (ianalumab or iscalimab) or placebo. At the end of Week 29 visit, the patients enter the open label treatment phase where patients in active treatment group continued to receive active treatment and patients in placebo group started active treatment with ianalumab/iscalimab until Week 49. After completion of the open-label treatment period, all patients enter a Follow-Up period in order to monitor safety and efficacy up to Week 69. The Week 69 visit is the End of Study (EoS) visit for patients in Cohort 2 (CFZ533). Study duration for patients in Cohort 2 will be approximately 18 months. For Cohort 1 (VAY736). Patients who do not achieve B-cell recovery by Week 69 Visit will enter into a Secondary Follow-Up period until achieving B cell recovery criteria (B-cell count is at \>= 50 cells/µl or at least 80% of baseline levels). Safety follow-up visits will be scheduled as deemed appropriate until the patient achieves the B cell recovery criteria, followed by an EoS 4 weeks later.
Age
18 - 75 years
Sex
ALL
Healthy Volunteers
No
Novartis Investigative Site
Ciudad Autonoma de Bs As, Buenos Aires, Argentina
Novartis Investigative Site
Clayton, Victoria, Australia
Novartis Investigative Site
Guangzhou, Guangdong, China
Novartis Investigative Site
Nanjing, Jiangsu, China
Novartis Investigative Site
Shanghai, China
Novartis Investigative Site
Prague, Czechia
Novartis Investigative Site
Pessac, France
Novartis Investigative Site
Freiburg im Breisgau, Baden-Wurttemberg, Germany
Novartis Investigative Site
Berlin, Germany
Novartis Investigative Site
Budapest, Hungary
Start Date
December 19, 2018
Primary Completion Date
July 27, 2022
Completion Date
April 28, 2025
Last Updated
October 7, 2025
107
ACTUAL participants
VAY736
DRUG
VAY736 Placebo
DRUG
CFZ533
DRUG
CFZ533 Placebo
DRUG
Lead Sponsor
Novartis Pharmaceuticals
NCT06647069
NCT06875960
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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