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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)

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Trial Profile

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)

Status: Active, no longer recruiting
Phase of Trial: Phase II

Latest Information Update: 28 Feb 2025

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At a glance

  • Drugs Ianalumab (Primary) ; Iscalimab (Primary)
  • Indications Systemic lupus erythematosus
  • Focus Therapeutic Use
  • Sponsors Novartis; Novartis Pharma KK; Novartis Pharmaceuticals

Most Recent Events

  • 28 Jun 2024 The study has been Completed in Germany, According to European Clinical Trials Database record.
  • 15 Jun 2024 Results assessing changes in B-cell subsets, whole blood transcriptome and antibodies against extractable nuclear antigens (ENA) in patients with systemic lupus erythematosus (SLE) pre- and post-treatment with ianalumab to characterize pharmacodynamic (PD) biomarkers and biological pathways linked to mechanism of action and clinical response presented at the 25th Annual Congress of the European League Against Rheumatism
  • 15 Jun 2024 Results (n=67) reporting longer-term data from additional 24-week open-label ianalumab treatment portion of this trial presented at the 25th Annual Congress of the European League Against Rheumatism

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