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

Multiple Sclerosis, Acute Relapsing Clinical Trial

Official title:

A Double-Blind, Placebo-Controlled, Single Ascending Dose Intravenous Infusion Study of rHIgM22 in Patients With Multiple Sclerosis Immediately Following a Relapse

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02398461
• Other study ID #: IM22-MS-1033
• Status: Completed
• Phase: Phase 1
• Start date: April 2015
• Est. completion date: September 21, 2017

Study information

• Verified date: May 2017
• Source: Acorda Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: September 21, 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

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.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Acute Relapsing
• Multiple Sclerosis, Relapsing-Remitting
• Sclerosis

Intervention

Drug:
• rHIgM22
Administered via IV infusion
• Placebo

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Acorda Therapeutics	PRA Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Up to 180 days
Secondary	Maximum measured plasma concentration (Cmax) of single ascending doses of rHIgM22		Pre-dose (day 1), specified time points up to 48 hours post treatment
Secondary	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
Secondary	Half-life (T1/2) of single ascending doses of rHIgM22		Pre-dose (day 1), specified time points up to 48 hours post treatment
Secondary	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
Secondary	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.	Specified time points up to 180 days post treatment
Secondary	The Expanded Disability Status Scale (EDSS)		Screening, specified time points up to 180 days post treatment