SHS_543112 BOWJ CALK 15280

A Phase 3 Open Label Study to Evaluate the Long-term Safety and Tolerability of ALKS 8700 in Adults With Relapsing Remitting Multiple Sclerosis

This study will evaluate the long-term safety and tolerability of ALKS 8700 for the treatment of Relapsing Remitting Multiple Sclerosis (RRMS)

Inclusion Criteria:

•Has a confirmed diagnosis of RRMS
•Neurologically stable with no evidence of relapse within 30 days prior to Visit 2
•Additional criteria may apply

Exclusion Criteria:

•Subject is pregnant or breastfeeding or plans to become pregnant or begin breastfeeding at any point during the study and for 30 days after any study drug administration
•Diagnosis of primary progressive secondary progressive, or progressive relapsing MS
•History of clinically significant cardiovascular, pulmonary, gastrointestinal (inflammatory bowel disease [IBD]; Crohn's disease, ulcerative colitis), dermatologic, psychiatric, neurologic (other than MS), and/or other major disease that would preclude participation in a clinical trial
•History of a myocardial infarction, including a silent myocardial infarction identified on ECG, or unstable angina
•Additional criteria may apply
Phase III
NCT02634307
Neurosciences
Multiple Sclerosis
James Bowen, M.D.
Alkermes, Inc.
Desiree Iriarte
  • Swedish Medical Center