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Efficacy and Safety Study of Ozanimod in Relapsing Multiple Sclerosis

NCT02047734 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1320

Last updated 2021-02-11

Study results available
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Summary

This study is a two-part trial consisting of Part A (see NCT01628393) and Part B, presented within this record.

The primary objective of Part B is to assess whether the clinical efficacy of ozanimod (RPC1063) is superior to interferon beta-1a (IFN β-1a; Avonex®) in reducing the rate of clinical relapses at the end of Month 24 in patients with relapsing multiple sclerosis (RMS).

Conditions

Interventions

DRUG

Ozanimod

Oral capsule, daily for 24 months

DRUG

Ozanimod placebo

Oral capsule, daily for 24 months

DRUG

Interferon beta-1a

Intramuscular injection, 30 µg, weekly for 24 months

DRUG

Interferon beta-1a placebo

Intramuscular injection, weekly for 24 months

Sponsors & Collaborators

  • Celgene

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-12-03
Primary Completion
2017-03-27
Completion
2017-04-13

Countries

  • United States
  • Belarus
  • Belgium
  • Bosnia and Herzegovina
  • Bulgaria
  • Canada
  • Croatia
  • Georgia
  • Greece
  • Hungary
  • Italy
  • Moldova
  • Poland
  • Romania
  • Russia
  • Serbia
  • Slovakia
  • South Africa
  • Spain
  • Ukraine
  • United Kingdom

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02047734 on ClinicalTrials.gov