A Phase 2/3, Multi-center, Randomized, Double-blind, Placebo-controlled (Part A) and Double-blind, Double-dummy, Active-controlled (Part B), Parallel Group Study to Evaluate the Efficacy and Safety of RPC1063 Administered Orally to Relapsing Multiple Sclerosis Patients

Trial Profile

A Phase 2/3, Multi-center, Randomized, Double-blind, Placebo-controlled (Part A) and Double-blind, Double-dummy, Active-controlled (Part B), Parallel Group Study to Evaluate the Efficacy and Safety of RPC1063 Administered Orally to Relapsing Multiple Sclerosis Patients

Completed
Phase of Trial: Phase II/III

Latest Information Update: 11 Apr 2018

At a glance

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

    • 27 Feb 2018 According to a Celgene Corporation media release, company has received a Refusal to File letter from the United States Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for ozanimod, and now the Company intends to seek immediate guidance, including requesting a Type A meeting with the FDA, to ascertain what additional information will be required to resubmit the NDA.
    • 25 Jan 2018 According to a Celgene Corporation media release, the company is planning to submit a Marketing Authorization Application (MAA) with the EMA in the first quarter of 2018.
    • 25 Jan 2018 According to a Celgene Corporation media release, in December 2017, a New Drug Application (NDA) was submitted with the FDA for ozanimod in relapsing multiple sclerosis (RMS) based on data from the phase III RADIANCE Part B and SUNBEAM trials.
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