The goal of this Phase 2 clinical trial is to investigate the safety and tolerability of SUN-627 in men and women aged 18-70 years old with a diagnosis of non-active SPMS/PPMS.
This Phase 2a, randomized, double-blind, placebo-controlled study will evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and impact on measures of neuroinflammation in the central nervous system (CNS) of SUN-627 administered at 2 dose levels in participants with non-active SPMS/PPMS.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
20
Local Institution - Site 102
Atlanta, Georgia, United States
RECRUITINGLocal Institution - Site 101
Raleigh, North Carolina, United States
RECRUITINGLocal Institution - Site 104
Columbus, Ohio, United States
RECRUITINGIncidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) compared to placebo
Time frame: From enrollment to the end of study at 16 weeks
The maximum concentration (Cmax) of SUN-627 in plasma
Time frame: From enrollment to end of treatment at 12 weeks
Change from baseline in neuroinflammation biomarkers
Time frame: From enrollment to the end of treatment at 12 weeks
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