An Intravenous Infusion Study of rHIgM22 in Patients With Multiple Sclerosis Immediately Following a Relapse

Phase 1

Completed

Brief Summary: This is a Phase 1, multi-center, double-blind, randomized, placebo-controlled, dose-escalation study in subjects with relapsing Multiple Sclerosis (MS). The primary outcome will be the safety and tolerability of a single dose of rHIgM22 in relapsing MS subjects.

Recruitment & Eligibility

Inclusion Criteria

Males or females (18-70 years of age; < 104 kg)
Capable of giving informed consent
Meet diagnostic criteria for MS, as defined by revised (2010) McDonald criteria
Present with a clinical acute relapse defined as a new or worsening neurological symptoms attributable to MS preceded by a stable or improving neurological state of at least 30 days, not associated with fever or infection, lasting at least 24 hours and accompanied by an objective physical (neurological) exam finding as confirmed by the Investigator
Has at least one new, identifiable, measurable and active lesion on MRI (Gd+) meeting the criteria of the imaging charter.

Exclusion Criteria

Certain specified co-morbidities (including pregnancy)
Taking certain proscribed medications
A medical regimen that has changed in the month prior to screening
Inability to undergo requisite MRI evaluations
Drug or alcohol abuse
Any other reason for which, in the opinion of the Investigator, the subject should not participate in the study.

Arm && Interventions

Group	Intervention	Description
rHIgM22	rHIgM22	Patients will be enrolled sequentially in 2 separate cohorts, representing escalating dose levels. Each dose cohort will comprise 15 subjects, randomly assigned to receive either rHIgM22 (n=10) or placebo (n=5).
Placebo	Placebo	Patients will be enrolled sequentially in 2 separate cohorts, representing escalating dose levels. Each dose cohort will comprise 15 subjects, randomly assigned to receive either rHIgM22 (n=10) or placebo (n=5).

Primary Outcome Measures

Name	Time	Method
Safety and tolerability of single ascending doses of rHIgM22 in patients with MS immediately following a relapse as measured by the number of patients with Adverse Events (AEs)	Up to 180 days	Assessed by review of the AEs, including Serious Adverse Events (SAEs), clinical symptoms and signs, clinical laboratory tests and Electrocardiogram (ECGs).

Secondary Outcome Measures

Name	Time	Method
Half-life (T1/2) of single ascending doses of rHIgM22	Pre-dose (day 1), specified time points up to 48 hours post treatment
The Expanded Disability Status Scale (EDSS)	Screening, specified time points up to 180 days post treatment
Immunogenicity profile of single ascending doses of rHIgM22	Specified time points up to 180 days post treatment	Blood samples will be collected from subjects post treatment for assessment to detect the presence of anti-drug antibodies and neutralizing antibodies.
Maximum measured plasma concentration (Cmax) of single ascending doses of rHIgM22	Pre-dose (day 1), specified time points up to 48 hours post treatment
Time to maximum plasma concentration (Tmax) of single ascending doses of rHIgM22	Pre-dose (day 1), specified time points up to 48 hours post treatment
Area under the concentration curve from time 0 to the concentration at last time point (AUC0-last) of single ascending doses of rHIgM22	Pre-dose (day 1), specified time points up to 48 hours post treatment

Locations (12): Acorda Site #16
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Centennial, Colorado, United States
Acorda Site #22
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Chicago, Illinois, United States
Acorda Site #19
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Teaneck, New Jersey, United States
Acorda Site #6
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Seattle, Washington, United States
Acorda Site #12
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Long Beach, California, United States
Acorda Site #7
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San Francisco, California, United States
Acorda Site #3
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Sacramento, California, United States
Acorda Site #11
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Aurora, Colorado, United States
Acorda Site #14
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Saint Louis, Missouri, United States
Acorda Site #10
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Rochester, New York, United States
Acorda Site #18
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Dallas, Texas, United States
Acorda Site #2
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Seattle, Washington, United States