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

NCT03656562 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 107

Last updated 2026-05-14

Study results available
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Summary

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

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

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-19
Primary Completion
2022-07-27
Completion
2025-04-28
FDA Drug
Yes

Countries

  • Argentina
  • Australia
  • China
  • Czechia
  • France
  • Germany
  • Hungary
  • Israel
  • Japan
  • Poland
  • Russia
  • South Korea
  • Spain
  • Taiwan
  • Thailand

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03656562 on ClinicalTrials.gov