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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02398461
Recruitment Status : Completed
First Posted : March 25, 2015
Last Update Posted : August 22, 2018
Sponsor:
Collaborator:
PRA Health Sciences
Information provided by (Responsible Party):
Acorda Therapeutics

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
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 : April 2015
Actual Primary Completion Date : September 2017
Actual Study Completion Date : September 21, 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: 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
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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) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Pre-dose (day 1), specified time points up to 48 hours post treatment ]
  3. 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 ]
  4. 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 ]
  5. Immunogenicity profile of single ascending doses of rHIgM22 [ Time Frame: 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) [ Time Frame: Screening, specified time points up to 180 days post treatment ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02398461


Locations
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United States, California
Acorda Site #12
Long Beach, California, United States, 90806
Acorda Site #3
Sacramento, California, United States, 95817
Acorda Site #7
San Francisco, California, United States, 94158
United States, Colorado
Acorda Site #11
Aurora, Colorado, United States, 80045
Acorda Site #16
Centennial, Colorado, United States, 80112
United States, Illinois
Acorda Site #22
Chicago, Illinois, United States, 60612
United States, Missouri
Acorda Site #14
Saint Louis, Missouri, United States, 63131
United States, New Jersey
Acorda Site #19
Teaneck, New Jersey, United States, 07666
United States, New York
Acorda Site #10
Rochester, New York, United States, 14642
United States, Texas
Acorda Site #18
Dallas, Texas, United States, 75390-8508
United States, Washington
Acorda Site #2
Seattle, Washington, United States, 98101
Acorda Site #6
Seattle, Washington, United States, 98122
Sponsors and Collaborators
Acorda Therapeutics
PRA Health Sciences
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Acorda Therapeutics
ClinicalTrials.gov Identifier: NCT02398461    
Other Study ID Numbers: IM22-MS-1033
First Posted: March 25, 2015    Key Record Dates
Last Update Posted: August 22, 2018
Last Verified: May 2017
Additional relevant MeSH terms:
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Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
 Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases