The purpose of this study is to evaluate the safety and tolerability of IV administration of VX15/2503 in patients with multiple sclerosis. The escalation part of the study will determine the maximum tolerated dose (MTD) or the Maximum Administered Dose if no MTD is found.
VX15/2503-N-101 is a single ascending dose-escalation, randomized, double-blinded, placebo-controlled study to evaluate the safety and tolerability of IV-administered VX15/2503 in patients with multiple sclerosis. This will be accomplished by using a dose escalation procedure starting at a low dose of VX15/2503 and will continue based on predefined parameters until the maximum tolerated dose is identified. Patients will be randomized at a 4:1 ratio to receive VX15/2503 to placebo. The patients and the study team will be blinded to the treatment that each patient receives. The study drug, VX15/2503, is a humanized monoclonal antibody that binds to the semaphorin 4D (SEMA4D; CD100) antigen. Experimental evidence suggest that antibody neutralization of SEMA4D may represent a new therapeutic strategy for treating multiple sclerosis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
50
North Central Neurology Associates, PC
Cullman, Alabama, United States
University of Colorado Hospital, Aschutz Inpatient Pavilion
Aurora, Colorado, United States
Indiana University Health Neuroscience Center
Indianapolis, Indiana, United States
Safety/Tolerability as determined by number of patients with adverse events
Time frame: Up to 12 weeks depending on dose cohort
Half-life of VX15/2503
Time frame: Up to 12 weeks depending on dose cohort
Peak plasma concentration (Cmax) of VX15/2503
Time frame: Up to 12 weeks depending on dose cohort
Area under the plasma concentration versus time curve (AUC) of VX15/2503
Time frame: Up to 12 weeks depending on dose cohort
Number of patients who develop anti-drug antibody
Time frame: Up to 12 weeks depending on dose cohort
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University of Kansas Medical Center
Kansas City, Kansas, United States
Wayne State University - University Health Center
Detroit, Michigan, United States
MS Center of Northeastern NY/Empire Neurology
Latham, New York, United States
University of Rochester Medical Center
Rochester, New York, United States
The Neurological Institute, PA
Charlotte, North Carolina, United States
The Cleveland Clinic Foundation
Cleveland, Ohio, United States
Swedish Medical Center
Seattle, Washington, United States