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An adaptive Phase 2 randomized double-blind, placebo-controlled multi-center study to evaluate the safety and efficacy of multiple LOU064 doses in patients with moderate to severe Sjogren's Syndrome (LOUiSSe)

Trial Profile

An adaptive Phase 2 randomized double-blind, placebo-controlled multi-center study to evaluate the safety and efficacy of multiple LOU064 doses in patients with moderate to severe Sjogren's Syndrome (LOUiSSe)

Status: Discontinued
Phase of Trial: Phase II

Latest Information Update: 09 Nov 2023

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At a glance

  • Drugs Remibrutinib (Primary)
  • Indications Sjogren's syndrome
  • Focus Proof of concept; Therapeutic Use
  • Acronyms LOUiSSe
  • Sponsors Novartis; Novartis Pharma A.G.; Novartis Pharmaceuticals

Most Recent Events

  • 06 Nov 2023 Results of Efficacy and safety of remibrutinib, published in the Annals of the Rheumatic Diseases
  • 03 Jun 2023 Results identify protein and transcript signatures in the blood of patients with active SjS that are associated with remibrutinib treatment. presented at the 24th Annual Congress of the European League Against Rheumatism
  • 27 Apr 2023 Results presented at the 75th Annual Meeting of the American Academy of Neurology 2023

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