A Phase IV Study of Dimethyl Fumarate Enteric-coated Capsules for Relapsing Multiple Sclerosis (RMS)

Inclusion criteria

• Confirmed RMS per the 2017 McDonald criteria, including clinically isolated syndrome (CIS), relapsing-remitting MS (RRMS), or active secondary progressive MS (SPMS)
• At least one documented relapse within 12 months prior to screening; plus evidence of MS-consistent lesions on prior brain MRI or gadolinium-enhancing (GdE) lesions on an MRI performed within 6 weeks before screening
• Expanded Disability Status Scale (EDSS) score between 0.0 and 5.0 (inclusive) at screening

Exclusion criteria

• History or current diagnosis of malignancy (except fully resected basal cell carcinoma), or uncontrolled severe diseases of major organ systems (e.g., cardiac, renal, hepatic, neurological [excluding multiple sclerosis]) that, in the investigator's assessment, pose a significant risk to the subject or could confound study results.
• Protocol-defined multiple sclerosis (MS) relapse within 30 days prior to screening, or failure to achieve clinical stability from a prior relapse.
• History of suicidal behavior within 5 years prior to screening. Suicidal ideation (indicated by a "Yes" response to Item 4 or 5 on the C-SSRS) within 6 months prior to screening.Subjects with a history of suicidal behavior occurring >5 years prior to screening require investigator assessment of eligibility.