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

Acorda Therapeutics27 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Multiple Sclerosis, Acute Relapsing

Interventions

rHIgM22DRUG

Administered via IV infusion

PlaceboDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Locations (12)

Acorda Site #12

Long Beach, California, United States

Acorda Site #3

Sacramento, California, United States

Acorda Site #7

San Francisco, California, United States

Outcomes

Primary Outcomes

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)

Assessed by review of the AEs, including Serious Adverse Events (SAEs), clinical symptoms and signs, clinical laboratory tests and Electrocardiogram (ECGs).

Time frame: Up to 180 days

Secondary Outcomes

Maximum measured plasma concentration (Cmax) of single ascending doses of rHIgM22

Time frame: 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

Time frame: Pre-dose (day 1), specified time points up to 48 hours post treatment

Half-life (T1/2) of single ascending doses of rHIgM22

Time frame: 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

Time frame: Pre-dose (day 1), specified time points up to 48 hours post treatment

Immunogenicity profile of single ascending doses of rHIgM22

Blood samples will be collected from subjects post treatment for assessment to detect the presence of anti-drug antibodies and neutralizing antibodies.

Time frame: Specified time points up to 180 days post treatment

The Expanded Disability Status Scale (EDSS)

Time frame: Screening, specified time points up to 180 days post treatment

Data from ClinicalTrials.gov

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