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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
112
Pharmaceutical form: solution for infusion Route of administration: intravenous
Pharmaceutical form: solution for infusion Route of administration: intravenous
Reduction in the cumulative number of new contrast-enhancing lesions on MRI
Time frame: from Week 4 to Week 12
Safety: proportion of patients experiencing adverse events
Time frame: up to Week 104
Pharmacokinetics: serum concentrations of vatelizumab
Time frame: up to Week 32
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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
...and 22 more locations