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A Multicenter, Randomized, Double-blind, Placebo- Controlled Phase 2b Dose-finding Study to Investigate the Efficacy, Safety and Tolerability of LOU064 in Adult Chronic Spontaneous Urticaria (CSU) Patients Inadequately Controlled by H1-antihistamines

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Trial Profile

A Multicenter, Randomized, Double-blind, Placebo- Controlled Phase 2b Dose-finding Study to Investigate the Efficacy, Safety and Tolerability of LOU064 in Adult Chronic Spontaneous Urticaria (CSU) Patients Inadequately Controlled by H1-antihistamines

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 29 May 2024

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At a glance

  • Drugs Remibrutinib (Primary)
  • Indications Chronic urticaria
  • Focus Therapeutic Use
  • Sponsors Novartis; Novartis Pharmaceuticals

Most Recent Events

  • 18 Apr 2024 Results assessing serum immunoglobulin (Ig) levels in NCT03926611 and NCT04109313, presented at the 76th Annual Meeting of the American Academy of Neurology 2024.
  • 26 Feb 2024 Results assessing changes in total serum immunoglobulin (Ig) levels and exposure-adjusted incidence rate (EAIR) for infections in the Phase 2b core and extension studies presented at the 2024 Annual Meeting of the American Academy of Allergy, Asthma and Immunology
  • 13 Oct 2023 Results assessing safety data from two phase 2 studies NCT04109313 & NCT03926611 were presented at the 9th Triennial joint meeting of Americas Committee for Treatment and Research in Multiple Sclerosis and the European Committee for Treatment and Research in Multiple Sclerosis

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