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
Phase of Trial: Phase II/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 RADIANCE
- Sponsors Celgene Corporation; Celgene International SARL; Receptos
- 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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Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History