Tecfidera Slow-Titration Study

A Multicenter, Treatment-Blind Phase 3b Study to Evaluate Whether 6-Week Up-Titration in Tecfidera® Dose is Effective in Reducing the Incidence of Gastrointestinal Adverse Events in Patients With Multiple Sclerosis

The primary objective of the study is to assess whether a 6-week titration (compared with a 1-week titration) is effective in reducing the incidence of dimethyl fumarate (DMF [Tecfidera])-related gastrointestinal (GI) adverse events (AEs) in participants with multiple sclerosis (MS). The secondary objective of this study is to assess whether a 6-week titration (compared with a 1-week titration) is effective in reducing the average severity and duration of GI symptoms over 12 weeks of DMF treatment in this study population.

Key Inclusion Criteria:

• Diagnosis of MS consistent with locally labeled indication for DMF
• No prior treatment with DMF
• Female subjects of childbearing potential who are not surgically sterile and male subjects must practice effective contraception during their participation in the study
• Have had a recent complete blood count (CBC), including lymphocyte count, that does not preclude participation in the study, in the judgement of the investigator

Key Exclusion Criteria:

• Have a recent history or ongoing GI illness (e.g., peptic ulcer, irritable bowel syndrome) or any other current condition with GI signs and symptoms (e.g., nausea, vomiting, abdominal pain, or diarrhea) that may interfere with assessment of study endpoints
• Have other major comorbid conditions that preclude participation in the study, as determined by the investigator
• Participant is pregnant, breastfeeding, or planning a pregnancy during the study period
• Are receiving concomitant disease-modifying therapies for MS including, but not limited to, natalizumab, interferon beta, glatiramer acetate, fingolimod, alemtuzumab, teriflunomide, or laquinimod at screening
• History of severe allergic or anaphylactic reactions or known drug hypersensitivity
• NOTE: Other protocol defined Inclusion/Exclusion criteria may apply