BIP_abbvie M14-397 PMS
A Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study to Assess the Safety and Efficacy of Elezanumab when Added to Standard of Care in Progressive Forms of Multiple Sclerosis
The purpose of this study is to evaluate the safety and efficacy of elezanumab in subjects with progressive Multiple Sclerosis (PMS).
Key Inclusion Criteria:
-Male and female subjects ages 18-55
-Subject has diagnosis of primary-progressive multiple sclerosis (PPMS) or non-relapsing secondary-progressive multiple sclerosis (SPMS) and no relapses for at least 24 months
-Subject has evidence of physical disability according to Expanded Disability Status Scale (EDSS) or Timed 25-Foot Walk (T25FW) or 9-Hole Peg Test
Key Exclusion Criteria:
-Treatment with any of the following within the 6 months prior to Screening: natalizumab; cyclosporine; azathioprine; methotrexate; mycophenolate mofetil; intravenous immunoglobulin (IVIg); any interferon product; and intravenous (IV), oral, or intrathecal corticosteroids for the purposes of disease modification
-Treatment with the following within 1 year prior to Screening: cyclophosphamide or alemtuzumab
**Other protocol-defined inclusion/exclusion criteria may apply. Please click on the NCT Number (below) to learn more about the study at clinicaltrials.gov.**
Stanley Cohan, M.D., Ph.D.
- Providence St. Vincent Medical Center