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A Phase 3, Multi-Center, Randomized, Double-Blind, Double-Dummy, Active Controlled, Parallel Group Study To Evaluate The Efficacy And Safety Of RPC1063 Administered Orally To Relapsing Multiple Sclerosis Patients

Trial Profile

A Phase 3, Multi-Center, Randomized, Double-Blind, Double-Dummy, Active Controlled, Parallel Group Study To Evaluate The Efficacy And Safety Of RPC1063 Administered Orally To Relapsing Multiple Sclerosis Patients

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 09 Sep 2019

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At a glance

  • Drugs Ozanimod (Primary) ; Interferon beta-1a
  • Indications Multiple sclerosis
  • Focus Registrational; Therapeutic Use
  • Acronyms SUNBEAM
  • Sponsors Celgene International SARL; Receptos
  • Most Recent Events

    • 09 Sep 2019 According to an Celgene Corporation media release, data from this study will be presented at the 35th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS).
    • 30 Jul 2019 According to a Celgene Corporation media release, the Prescription Drug User Fee Act (PDUFA) date for ozanimod NDA is March 25, 2020 and a regulatory decision from the EMA is expected in the first half of 2020.
    • 06 Jun 2019 According to a Celgene corporation media release, the European Medicines Agency (EMA) also accepted for review the Marketing Authorization Application for ozanimod for the treatment of adults with relapsing-remitting multiple sclerosis (RRMS) in the European Union. Both the applications are based on the data of SUNBEAM and RADIANCE part B trials.
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