A Phase 2 Study of Atacicept in Subjects With Relapsing Multiple Sclerosis (ATAMS)
A Four-Arm Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase II Study to Evaluate the Safety, Tolerability and Efficacy as Assessed by Frequent MRI Measures of 3 Doses of Atacicept Monotherapy in Subjects With Relapsing Multiple Sclerosis (RMS) Over a 36 Week Treatment Course
Sponsor: EMD Serono
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Mean Number of Time Constant 1 (T1) Gadolinium (Gd)-Enhancing Lesions Per Participant Per Scan
Time frame: Weeks 12 to 36
Secondary Endpoints
Number of New T1 Gd-enhancing Lesions Per Participant
Percentage of Participants Free From Relapses
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs
Eligibility 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.
✦ Analyst Commentary
Expert commentary on why this trial matters and what to watch for.
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