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

Stopped early · Phase 2

Conditions studied: Relapsing-remitting Multiple Sclerosis

In brief

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

Key facts

Study ID

NCT02306811

Run by

Genzyme, a Sanofi Company

People needed

62

Starts

2015-02-01

Expected to finish

2016-07-01

Last updated by the study team

2016-12-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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.
• Other protocol defined exclusion criteria may apply.
• The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Where it is running

• Investigational Site Number 840004 — Cullman, Alabama, United States
• Investigational Site Number 840005 — Fort Collins, Colorado, United States
• Investigational Site Number 840007 — Ormond Beach, Florida, United States
• Investigational Site Number 840001 — Latham, New York, United States
• Investigational Site Number 840003 — Round Rock, Texas, United States
• Investigational Site Number 840016 — San Antonio, Texas, United States
• Investigational Site Number 124001 — Greenfield Park, Canada
• Investigational Site Number 616001 — Lodz, Poland
• Investigational Site Number 616004 — Lublin, Poland
• Investigational Site Number 616003 — Lublin, Poland
• Investigational Site Number 616002 — Szczecin, Poland
• Investigational Site Number 643010 — Kazan', Russia
• Investigational Site Number 643009 — Moscow, Russia
• Investigational Site Number 643006 — Nizhny Novgorod, Russia
• Investigational Site Number 643005 — Nizhny Novgorod, Russia
• Investigational Site Number 643008 — Novosibirsk, Russia
• Investigational Site Number 643002 — Saint Petersburg, Russia
• Investigational Site Number 643001 — Saint Petersburg, Russia

Full record on ClinicalTrials.gov

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