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Efficacy and Safety Study of Ozanimod (RPC1063) in Relapsing Multiple Sclerosis Patients

NCT01628393 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 258

Last updated 2021-02-11

Study results available
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Summary

This study is a two-part trial consisting of Part A (presented in this record) and Part B (see NCT02047734).

The primary objective in Part A of this study was to demonstrate the superior efficacy of ozanimod compared to placebo by showing a reduction in the cumulative number of total gadolinium-enhancing (GdE) lesions from Week 12 to Week 24 in patients with relapsing multiple sclerosis (RMS).

Conditions

Interventions

DRUG

Ozanimod

Oral capsule taken once a day

DRUG

Placebo

Oral capsule taken once a day

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
2012-09-18
Primary Completion
2014-04-13
Completion
2016-05-11

Countries

  • United States
  • Belgium
  • Bulgaria
  • Georgia
  • Greece
  • Hungary
  • Italy
  • Poland
  • Romania
  • Russia
  • Serbia
  • Spain
  • Ukraine

Study Locations

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Entities

Drugs
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 NCT01628393 on ClinicalTrials.gov