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

• Sponsor: Acorda Therapeutics (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02398461
• Collaborator: PRA Health Sciences (Industry)
• Enrollment: 27
• Locations: 12
• Arms: 2
• Duration (Months): 29.7
• Patients Per Site: 2.3
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Multiple Sclerosis, Acute Relapsing	Drug: rHIgM22; Drug: Placebo	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 27 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Double-Blind, Placebo-Controlled, Single Ascending Dose Intravenous Infusion Study of rHIgM22 in Patients With Multiple Sclerosis Immediately Following a Relapse
• Study Start Date: Apr 1, 2015
• Actual Primary Completion Date: Sep 1, 2017
• Actual Study Completion Date: Sep 21, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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).	Drug: rHIgM22; Administered via IV infusion; Other Names: M22
Placebo Comparator: 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).	Drug: Placebo

Outcome Measures

Primary Outcome Measures

1. 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

1. Maximum measured plasma concentration (Cmax) of single ascending doses of rHIgM22 [Pre-dose (day 1), specified time points up to 48 hours post treatment]

2. 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]

3. Half-life (T1/2) of single ascending doses of rHIgM22 [Pre-dose (day 1), specified time points up to 48 hours post treatment]

4. 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]

5. 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.

6. The Expanded Disability Status Scale (EDSS) [Screening, specified time points up to 180 days post treatment]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Acorda Site #12	Long Beach	California	United States	90806
2	Acorda Site #3	Sacramento	California	United States	95817
3	Acorda Site #7	San Francisco	California	United States	94158
4	Acorda Site #11	Aurora	Colorado	United States	80045
5	Acorda Site #16	Centennial	Colorado	United States	80112
6	Acorda Site #22	Chicago	Illinois	United States	60612
7	Acorda Site #14	Saint Louis	Missouri	United States	63131
8	Acorda Site #19	Teaneck	New Jersey	United States	07666
9	Acorda Site #10	Rochester	New York	United States	14642
10	Acorda Site #18	Dallas	Texas	United States	75390-8508
11	Acorda Site #2	Seattle	Washington	United States	98101
12	Acorda Site #6	Seattle	Washington	United States	98122

Sponsors and Collaborators

• Acorda Therapeutics
• PRA Health Sciences

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Acorda Therapeutics
• ClinicalTrials.gov Identifier: NCT02398461
• Other Study ID Numbers: IM22-MS-1033
• First Posted: Mar 25, 2015
• Last Update Posted: Aug 22, 2018
• Last Verified: May 1, 2017

• Additional relevant MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis

Study Results

No Results Posted as of Aug 22, 2018