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

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Relapsing-remitting Multiple Sclerosis

In brief

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.

Key facts

Study ID

NCT02222948

Run by

Genzyme, a Sanofi Company

People needed

112

Starts

2014-09-01

Expected to finish

2016-07-01

Last updated by the study team

2016-12-21

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of relapsing-remitting multiple sclerosis (RRMS). At least 1 documented relapse in the past 12 months. At least 1 contrast-enhancing lesion (CEL) on magnetic resonance imaging (MRI) in the past 12 months and/or at screening.
• At least 3 T2 lesions on screening MRI.

You may not qualify if…

• Diagnosis of primary progressive or secondary progressive MS. Expanded disability status scale (EDSS) score >5.5. Relapse within 30 days prior to enrollment. Prior immunosuppressive treatment within protocol-specified time periods. Prior treatment with natalizumab (Tysabri®). History of bleeding/platelet disorders, malignancy, certain infections as defined in the protocol, or any other past or current medical conditions that would adversely affect the patient's participation in the study.
• Pregnancy or breast-feeding. Other protocol-defined inclusion/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 840009 — Phoenix, Arizona, United States
• Investigational Site Number 840005 — Fort Collins, Colorado, United States
• Investigational Site Number 840014 — Washington D.C., District of Columbia, United States
• Investigational Site Number 840007 — Ormond Beach, Florida, United States
• Investigational Site Number 840012 — Tampa, Florida, United States
• Investigational Site Number 840001 — Latham, New York, United States
• Investigational Site Number 840015 — Knoxville, Tennessee, United States
• Investigational Site Number 840003 — Round Rock, Texas, United States
• Investigational Site Number 840016 — San Antonio, Texas, United States
• Investigational Site Number 840002 — Salt Lake City, Utah, United States
• Investigational Site Number 840008 — Seattle, Washington, United States
• Investigational Site Number 124001 — Greenfield Park, Canada
• Investigational Site Number 124002 — Québec, Canada
• Investigational Site Number 616008 — Bydgoszcz, Poland
• Investigational Site Number 616007 — Lodz, Poland
• 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 616006 — Warsaw, Poland
• Investigational Site Number 643010 — Kazan', Russia
• Investigational Site Number 643009 — Moscow, Russia
• Investigational Site Number 643003 — Moscow, Russia
• Investigational Site Number 643006 — Nizhny Novgorod, Russia

Full record on ClinicalTrials.gov

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