Secondary Progressive Multiple Sclerosis Clinical Trial
Official title:
A Phase 2B Randomised, Double-Blind, Placebo-Controlled Trial of the Efficacy and Safety of MIS416 in the Treatment of Subjects With Secondary Progressive Multiple Sclerosis
The purpose of this study is to determine whether MIS416 administered once weekly over 12 months is safe, tolerable, and improves a range of signs and symptoms associated with secondary progressive multiple sclerosis.
The primary objectives of the study are to:
1. Determine the efficacy of MIS416, relative to placebo, when administered repeatedly via
weekly intravenous (IV) administration to subjects with Secondary Progressive Multiple
Sclerosis, as assessed by its effect on measures of neuromuscular function.
2. Determine the safety and tolerability of a weekly regimen of MIS416.
The secondary objectives of the study are to:
1. Determine the effect of MIS416 on disease activity and neurodegeneration by assessing
changes in Magnetic Resonance Imaging (MRI) markers including lesions, whole brain
atrophy (WBA) and Magnetization Transfer Ratio (MTR).
2. Determine the effect of MIS416 on Patient Reported Outcomes (PRO) related to disability
and health status.
3. Assess, in a subset of subjects, the pharmacodynamic (PD) effects of MIS416, including
effects on serum, Peripheral Blood Mononuclear Cell (PBMC), and Cerebral Spinal Fluid
(CSF) cytokine/chemokine levels and expression patterns.
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