A Phase 2a/2b Double-Blind, Randomized, Placebo-Controlled Study Assessing Efficacy, Safety, and Dose-Response of Vatelizumab in Patients with Relapsing-Remitting Multiple Sclerosis (RRMS)

INTERVENTION: Product Code: SAR339658 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: Vatelizumab CAS Number: 1238217‐55‐4 Current Sponsor code: SAR339658 Other descriptive name: CHR‐1103 / GBR500 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 10‐ Pharmaceutical form of the placebo: Solution for infusion Route of administration of the placebo: Intravenous use CONDITION: Nervous System Diseases ; MedDRA version: 17.1 Level: PT Classification code 10063399 Term: Relapsing‐remitting multiple sclerosis System Organ Class: 10029205 ‐ Nervous system disorders Therapeutic area: Diseases [C] ‐ Nervous System Diseases [C10] PRIMARY OUTCOME: Main Objective: To assess the efficacy of vatelizumab compared to placebo as measured by a reduction in new contrast‐enhancing lesions (CELs) in RRMS patients; To evaluate mutiple doses of vatelizumab for a dose‐response.; Primary end point(s): Reduction in the cumulative number of new CELs on MRI compared to placebo Secondary Objective: To evaluate the safety and tolerability of vatelizumab compared to placebo; To evaluate the pharmacokinetics (PK) of vatelizumab; Timepoint(s) of evaluation of this end point: from Week 4 to Week 12; SECONDARY OUTCOME: Secondary end point(s): Safety: proportion of patients experiencing adverse events ; Pharmacokinetics: serum concentrations of vatelizumab ; Timepoint(s) of evaluation of this end point: Safety: proportion of patients experiencing adverse events : up to 32 weeks ; Pharmacokinetics: serum concentrations of vatelizumab : up to 32 weeks ; 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range 168 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range