This is a randomized, double-blind study of PIPE-307 or placebo in subjects with relapsing-remitting multiple sclerosis. Subjects will be randomized into 1 of 3 separate cohorts (1:1:1 randomization ratio, PIPE-307 Dose A:PIPE-307 Dose B: Placebo) for a total duration of approximately 30 weeks.
This is a randomized, double-blind study of PIPE-307 or placebo given to 168 subjects randomized into one of 3 separate cohorts. They will be randomized 1:1:1 (PIPE-307 Dose A:Pipe 307 Dose B: Placebo). There will be a 28-day screening period followed by a 26-week treatment period. Safety will be assessed by periodic measurements of vital signs (VS), physical (PE) and neurological examinations, electrocardiograms (ECG), blood laboratory analyses and occurrence of adverse events (AE).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
182
Subjects will receive daily oral doses of PIPE-307
Subjects will receive daily oral doses of PIPE-307
Subjects will receive daily oral matching dose of Placebo
Xenosciences
Phoenix, Arizona, United States
Treatment-emergent adverse events (TEAE)
Number of participants with TEAEs
Time frame: From baseline to week 26 (end of treatment period)
Change in binocular 2.5% low contrast letter acuity (LCLA)
Time frame: From baseline to week 26 (end-of-study)
Percentage of subjects with >/=5-letter gain in binocular 2.5% LCLA
Time frame: From baseline to week 26
Change in monocular 2.5% LCLA
Time frame: From baseline to week 26
Number of subjects with at least a 15% change in disability with the Timed 25-Foot Walk Test (T25WT)
Time frame: From baseline to week 26
Number of subjects with at least a 15% change in disability with the Nine-Hole Peg Test (9HPT)
Time frame: From baseline to week 26
Number of subjects with at least a 15% change in disability with the Symbol Digital Modality Test (SDMT)
Time frame: From baseline to week 26
Change in magnetic resonance imaging (MRI) measures of myelination and MS disease activity
Time frame: From baseline to week 26
Change in serum neurofilament light chain (NfL)
Time frame: From baseline to week 26
Pharmacokinetics: Change in blood concentration levels of PIPE-307
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Time frame: From baseline to week 30