A Study to Assess the Effect of a Single Infusion of VAY736 on Disease Activity in Patients With Relapsing-remitting Multiple Sclerosis
Status: | Completed |
---|---|
Conditions: | Neurology, Neurology |
Therapuetic Areas: | Neurology |
Healthy: | No |
Age Range: | 18 - 55 |
Updated: | 10/19/2018 |
Start Date: | December 20, 2013 |
End Date: | September 13, 2018 |
A Randomized, Partially Blind, Placebo-controlled, Proof-of-concept Study to Assess the Effect of a Single Infusion of VAY736 on Disease Activity as Measured by Brain MRI Scans in Patients With Relapsing-remitting Multiple Sclerosis
The aim of this study is to determine if a monoclonal antibody VAY736 can reduce disease
activity in relapsing-remitting multiple sclerosis (RRMS) as compared to placebo. The study
will also provide the first safety and tolerability information for VAY736 in RRMS patients.
activity in relapsing-remitting multiple sclerosis (RRMS) as compared to placebo. The study
will also provide the first safety and tolerability information for VAY736 in RRMS patients.
Inclusion Criteria:
18 Years to 55 Years Male and Female
- Diagnosis of MS as defined by the 2010 revised McDonald criteria (Polman, et. al2011).
- 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.
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
- Women of child-bearing potential, defined as all women physiologically capable of
becoming pregnant, unless they are using highly effective methods of
contraception during dosing and for 4 months following completion of the study.
- Unable to undergo MRI scans due to inter-alia, claustrophobia, incompatible
cardiac pacemakers, ferromagnetic intracranial aneurysm clips, certain cochlear
implants, and certain other ferromagnetic foreign bodies (e.g. tattoos containing
metal) or electronic devices, or metallic implants incompatible with MRI.
- Unable to receive gadolinium-based MRI contrast agents due to a history of
hypersensitivity to gadolinium-based contrast agents, renal insufficiency or
impairment.
Other protocol-defined inclusion/exclusion criteria may apply
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