A Safety and Efficacy Study of ELND002 in Patients With Relapsing Forms of Multiple Sclerosis

A Phase 1b, Dose-Escalating, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Safety and Efficacy of Subcutaneous ELND002 in Patients With Relapsing Forms of Multiple Sclerosis

The purpose of this study is to determine the safety and tolerability of ELND002 in patients with relapsing forms of secondary progressive multiple sclerosis (SPMS) or relapsing-remitting multiple sclerosis (RRMS).

Inclusion Criteria:

• Has either clinically definite or laboratory-supported definite relapsing forms of MS for at least 2 years
• Patients with SPMS or RRMS have documented medical history of relapse in the past year or MRI-documented evidence of MS activity in the past year
• Has had an inadequate response or intolerability to interferon and/or glatiramer acetate
• Is able and willing to undergo Gd administration and repeat MRI testing

Exclusion Criteria:

• Has primary progressive MS (PPMS)
• Any history of treatment with recombinant humanized monoclonal antibodies
• Has received treatment with immunosuppressant medications or experimental agents within 3 months prior to the Baseline
• A history of opportunistic infection or the presence of any active infection within 3 months prior to Baseline
• Any history of congestive heart failure or currently has a pacemaker
• Has a known or suspected hypersensitivity to sulfonamides or any of the components of the investigational drug
• Has any medical history or psychiatric condition that would impact outcome or study participation
• Has other clinically significant abnormality on physical, neurological, laboratory, or ECG examination as listed in the protocol during the Screening Phase