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

The duration of study per patient will be up to 108 weeks, including a screening period of
up to 4 weeks, a treatment period of 12 weeks and a post-treatment safety follow-up period
of up to 92 weeks.

Patients completing the 12-week treatment period may enter an optional long-term extension
study in which all subjects will receive vatelizumab.

Inclusion criteria:

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.

Exclusion criteria:

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.