A Phase 2 Study of Atacicept in Subjects With Relapsing Multiple Sclerosis (ATAMS)

• Status: Terminated
• Trial end date: 2009-09-01
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate the safety and tolerability of atacicept and to explore if atacicept reduces central nervous system inflammation in subjects with relapsing multiple sclerosis (RMS) as assessed by frequent magnetic resonance imaging (MRI). This study is randomised. Study medication is administered via subcutaneous (under the skin) injections.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: EMD Serono

Criteria

Inclusion Criteria:

• Diagnosis of RMS (as per McDonald criteria, 2005) Other protocol-defined inclusion criteria could apply.

Exclusion Criteria:

• Have primary progressive multiple sclerosis (MS)

• Have secondary progressive MS without superimposed relapses

• Relevant cardiac, hepatic and renal diseases as specified in the protocol

• Pretreatment with immunosuppressants and immunomodulating drugs as specified in the protocol

• Clinical significant abnormalities in blood cell counts and immunoglobulin levels as specified in the protocol

• Clinical significant acute or chronic infections as specified in the protocol Other protocol-defined exclusion criteria could apply.