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A Multicenter, Double-blind, Placebo-controlled, Randomized Withdrawal and Open-label Extension Study Followed by Long-term Open-label Treatment Cycles to Assess the Efficacy, Safety and Tolerability of Remibrutinib (LOU064) in Adult Chronic Spontaneous Urticaria Patients Who Completed the Preceding Remibrutinib Phase 3 Studies

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Trial Profile

A Multicenter, Double-blind, Placebo-controlled, Randomized Withdrawal and Open-label Extension Study Followed by Long-term Open-label Treatment Cycles to Assess the Efficacy, Safety and Tolerability of Remibrutinib (LOU064) in Adult Chronic Spontaneous Urticaria Patients Who Completed the Preceding Remibrutinib Phase 3 Studies

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

Latest Information Update: 13 May 2025

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At a glance

  • Drugs Remibrutinib (Primary)
  • Indications Chronic urticaria
  • Focus Registrational; Therapeutic Use
  • Sponsors Novartis; Novartis Pharma A.G.; Novartis Pharmaceuticals

Most Recent Events

  • 07 Mar 2025 Planned End Date changed from 13 Feb 2027 to 2 Aug 2027.
  • 27 Sep 2024 Planned primary completion date changed from 1 Jul 2027 to 12 Feb 2027.
  • 19 Sep 2024 Planned End Date changed from 10 Aug 2027 to 13 Feb 2027.

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