Relapsing-remitting Multiple Sclerosis
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGVatelizumab
Pharmaceutical form: solution for infusion Route of administration: intravenous
DRUGPlacebo (for Vatelizumab)
Pharmaceutical form: solution for infusion Route of administration: intravenous
Sponsors
Genzyme, a Sanofi Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction in the cumulative number of new contrast-enhancing lesions on MRI | from Week 4 to Week 12 |
Secondary
| Measure | Time frame |
|---|---|
| Safety: proportion of patients experiencing adverse events | up to Week 104 |
| Pharmacokinetics: serum concentrations of vatelizumab | up to Week 32 |
Countries
Canada, Poland, Russia, Sweden, United States
Outcome results
None listed