The primary objective is to establish the safety of administration of intranasal Foralumab in non-active primary and secondary progressive Multiple Sclerosis (MS) patients in a multiple ascending dose format in escalating doses for 14 consecutive days.
This is a Phase 1b double blind, randomized, placebo controlled, dose escalating study evaluating multiple doses of Foralumab via intranasal administration for 14 days in patients with MS. Up to 55 untreated primary and secondary progressive MS patients will be enrolled, to obtain a total of 48 completed subjects (9 active, 3 placebos per group), allowing for dropouts.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
The Aptar Unidose device will be used to deliver foralumab nasal solution intranasally. Foralumab nasal solution is prepackaged in a Type 1 glass vial inside the Unidose device.
The placebo nasal solution is the acetate buffer vehicle used for foralumab nasal solution. It will be handled in a manner identical to active drug.
To establish the safety of intranasal foralumab in non-active primary and secondary progressive MS in escalating doses for 14 consecutive days
Analyses through review of adverse events categorized and graded via CTCAE.
Time frame: 14 days
Change in Expanded Disability Status Scale (EDSS) at Day 45
The EDSS scale ranges from 0 to 10 in 0.5 unit increments that represent higher levels of disability. Scoring is based on an examination by a neurologist. EDSS steps 1.0 to 4.5 refer to people with MS who are able to walk without any aid and is based on measures of impairment in eight functional systems. Lower score indicates that the subject is doing better.
Time frame: 45 days
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