A Study to Assess the Effect of a Single Infusion of VAY736 on Disease Activity in Patients With Relapsing-remitting Multiple Sclerosis

Key inclusion criteria:

Male and female patients aged 18 to 55 years.
Diagnosis of MS as defined by the 2010 revised McDonald criteria (Polman et al 2011).

A relapsing-remitting course of disease with:

at least 1 documented relapse during the previous 12 months (but not within 30 days prior to randomization ), or
a positive Gd-enhancing lesion on brain MRI scan at screening.
An Expanded Disability Status Scale (EDSS) score of 0-5.0 inclusive at screening.
No evidence of a relapse within 30 days prior to randomization.

Key exclusion criteria:

A manifestation of another type of MS other than RRMS.
Findings on screening or baseline brain MRI inconsistent with the diagnosis of MS.
History of chronic disease of the immune system other than MS, or a known immunodeficiency syndrome.
Score "yes" on item 4 or item 5 of the Suicidal Ideation section of the C-SSRS, if this ideation occurred in the past 6 months, or "yes" on any item of the Suicidal Behavior section, except for the "Non-Suicidal Self-Injurious Behavior" (item also included in the Suicidal Behavior section), if this behavior occurred in the past 2 years.
Women of child-bearing potential and Pregnant or nursing (lactating) women.
Screening CBC (complete blood count) laboratory values as follows:
Hemoglobin levels below 10.0 g/dL
Total leukocyte count less than 3,000 cells/µL
Neutropenia, defined as absolute neutrophil counts less than 1500 cells/mm3
Platelets less than 100,000/µL