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A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Study of Baricitinib in Patients With Systemic Lupus Erythematosus

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Trial Profile

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Study of Baricitinib in Patients With Systemic Lupus Erythematosus

Status: Discontinued
Phase of Trial: Phase III

Latest Information Update: 13 Sep 2023

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At a glance

  • Drugs Baricitinib (Primary)
  • Indications Systemic lupus erythematosus
  • Focus Registrational; Therapeutic Use
  • Acronyms BRAVE I; SLE-BRAVE-I
  • Sponsors Eli Lilly and Company

    • Most Recent Events

    • 24 Feb 2023 Results (n=760) assessing the efficacy and safety of baricitinib in patients with active systemic lupus erythematosus in a 52-week phase 3 study, published in The Lancet.
    • 04 Jun 2022 Results of a pooled safety analysis from three clinical studies: NCT02708095, NCT03616912 and NCT03616964 presented at the 23rd Annual Congress of the European League Against Rheumatism
    • 04 Jun 2022 Results assessing efficacy and safety of baricitinib in patients with systemic lupus erythematosus in two studies (SLE-BRAVE-I (NCT03616912) and -II (NCT03616964)), presented at the 23rd Annual Congress of the European League Against Rheumatism.

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