A Study to Assess the Effect of a Single Infusion of VAY736 on Disease Activity in Patients With Relapsing-remitting Multiple Sclerosis
A Study to Assess the Effect of a Single Infusion of VAY736 on Disease Activity in Patients With Relapsing-remitting Multiple Sclerosis
This was a randomized, partially blinded, placebo-controlled, non-confirmatory study to
 assess the effects of a single infusion of VAY736 on disease activity as measured by brain
 MRI scans in patients with relapsing-remitting multiple sclerosis (RRMS).
The study was planned to be conducted in approximately 96 patients. However, after enrolling
 8 patients, the recruitment was terminated based on strategic considerations.
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