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A Randomized, Double-blind, Placebo-controlled Extension Study to Assess the Long-term Safety and Tolerability of Ianalumab in Patients With Systemic Lupus Erythematosus (SIRIUS-SLE Extension)

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Trial Profile

A Randomized, Double-blind, Placebo-controlled Extension Study to Assess the Long-term Safety and Tolerability of Ianalumab in Patients With Systemic Lupus Erythematosus (SIRIUS-SLE Extension)

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 11 Jun 2025

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At a glance

  • Drugs Ianalumab (Primary)
  • Indications Systemic lupus erythematosus
  • Focus Adverse reactions; Registrational
  • Acronyms SIRIUS-SLE LTE
  • Sponsors Novartis Pharmaceuticals

Most Recent Events

  • 07 Oct 2024 According to a DelveInsight media release, the company plans to submit for Ianalumab approval by 2027, according to a recent presentation.
  • 16 May 2024 Planned End Date changed from 9 Dec 2031 to 23 Dec 2031.
  • 16 May 2024 Planned primary completion date changed from 9 Dec 2031 to 25 Dec 2029.

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