Efficacy and Safety of Vatelizumab in Patients With Relapsing-Remitting Multiple Sclerosis (EMPIRE)
Relapsing-remitting Multiple Sclerosis
About this trial
This is an interventional treatment trial for Relapsing-remitting Multiple Sclerosis
Eligibility Criteria
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.
Sites / Locations
- Investigational Site Number 840004
- Investigational Site Number 840009
- Investigational Site Number 840005
- Investigational Site Number 840014
- Investigational Site Number 840007
- Investigational Site Number 840012
- Investigational Site Number 840001
- Investigational Site Number 840015
- Investigational Site Number 840003
- Investigational Site Number 840016
- Investigational Site Number 840002
- Investigational Site Number 840008
- Investigational Site Number 124001
- Investigational Site Number 124002
- Investigational Site Number 616008
- Investigational Site Number 616007
- Investigational Site Number 616001
- Investigational Site Number 616004
- Investigational Site Number 616003
- Investigational Site Number 616002
- Investigational Site Number 616006
- Investigational Site Number 643010
- Investigational Site Number 643009
- Investigational Site Number 643003
- Investigational Site Number 643005
- Investigational Site Number 643006
- Investigational Site Number 643008
- Investigational Site Number 643002
- Investigational Site Number 643011
- Investigational Site Number 643001
- Investigational Site Number 752002
- Investigational Site Number 752001
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Experimental
Experimental
Experimental
Experimental
Placebo Comparator
Vatelizumab Dose 1
Vatelizumab Dose 2
Vatelizumab Dose 3
Vatelizumab Dose 4
Placebo
Vatelizumab dose 1 at Weeks 0, 2, 4 and 8
Vatelizumab dose 2 at Weeks 0, 2, 4 and 8
Vatelizumab dose 3 at Weeks 0, 2, 4 and 8
Vatelizumab dose 4 at Weeks 0, 2, 4 and 8
Placebo (for Vatelizumab) at Weeks 0, 2, 4 and 8