MedTrace Logo

Efficacy and Safety of Vatelizumab in Patients With Relapsing-Remitting Multiple Sclerosis

NCT02222948 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 112

Last updated 2016-12-21

No results posted yet for this study

Summary

Primary Objectives:

* To assess the efficacy of vatelizumab compared to placebo as measured by a reduction in new contrast-enhancing lesions (CELs) in relapsing remitting multiple sclerosis (RRMS) patients.
* To evaluate multiple doses of vatelizumab for a dose-response.

Secondary Objectives:

* To evaluate the safety and tolerability of vatelizumab compared to placebo.
* To evaluate the pharmacokinetics (PK) of vatelizumab.

Conditions

  • Relapsing-remitting Multiple Sclerosis

Interventions

DRUG

Vatelizumab

Pharmaceutical form: solution for infusion Route of administration: intravenous

DRUG

Placebo (for Vatelizumab)

Pharmaceutical form: solution for infusion Route of administration: intravenous

Sponsors & Collaborators

  • Genzyme, a Sanofi Company

    lead INDUSTRY

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

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
2014-09-30
Primary Completion
2016-04-30
Completion
2016-07-31

Countries

  • United States
  • Canada
  • Poland
  • Russia
  • Sweden

Study Locations

More Related Trials

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 NCT02222948 on ClinicalTrials.gov