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TERMINATEDPhase 2NCT02306811

Efficacy and Safety of Vatelizumab in Patients Who Completed Treatment in Study DRI13839

Primary Objective: To assess the long-term safety of vatelizumab in MS patients Secondary Objective: To assess the long-term efficacy of vatelizumab

Lead sponsor: Genzyme, a Sanofi Company•6 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Genzyme, a Sanofi Company

The maximum study duration per patient will be 192 weeks, including a Treatment Period of 96 weeks and Post-treatment Safety Follow-up Period of 96 weeks.

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

Inclusion Criteria

•Patients who completed the 12-week treatment period in DRI13839.

Exclusion Criteria

•Any clinically significant or ongoing adverse events, or laboratory abnormalities from DRI13839 that per Investigator judgment would adversely affect the patient's participation in the long-term extension study.
•Confirmed platelet count below the lower limit of normal at any time during DRI13839.
•Pregnancy or breast-feeding.
•The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: December 21, 2016Terms

Trial snapshot

StatusTERMINATED

PhasePHASE2

Enrollment62

Start dateFeb 2015

Last updatedDec 21, 2016

Condition

Relapsing-remitting Multiple Sclerosis

Locations shown

Investigational Site Number 840004

Cullman, Alabama

Investigational Site Number 840005

Fort Collins, Colorado

Investigational Site Number 840007

Ormond Beach, Florida

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 21, 2016Data synced to Clareo: May 17, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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