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Trial record 1 of 1 for:    NCT01803867
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An Intravenous Infusion Study of rHIgM22 in Patients With Multiple Sclerosis (M22)

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ClinicalTrials.gov Identifier: NCT01803867
Recruitment Status : Completed
First Posted : March 4, 2013
Last Update Posted : February 27, 2015
PRA Health Sciences
Information provided by (Responsible Party):
Acorda Therapeutics

Brief Summary:
This is a Phase I, multi-center, double-blind, randomized, placebo-controlled, dose-escalation study designed to evaluate safety, tolerability, pharmacokinetics, and immunogenicity of single intravenous (IV) administrations of rHIgM22 in patients with all clinical presentations of MS.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Drug: rHIgM22 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 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 Intravenous Infusion Study of Recombinant Human Immunoglobulin M (rHIgM22) in Patients With Multiple Sclerosis (MS)
Study Start Date : March 2013
Actual Primary Completion Date : October 2014
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Placebo Comparator: rHIgM22

Cohorts 1-5: In each dosing cohort, the first 2 eligible patients will be enrolled and randomized 1:1 to receive rHIgM22 or placebo, and monitored for safety for a minimum of 7 days before the remaining 8 patients in the cohort are randomized (7 active: 1 placebo) and dosed.

Expanded Cohort: Upon establishment of a Maximally Tolerated Dose (MTD), a new group of 21 patients will be enrolled in an Expansion Cohort. Randomly assigned in a 1:1:1 ratio to 1 of 3 treatment groups: placebo, Investigational Product (IP) at MTD, or IP at one full dose level lower than MTD.

Drug: rHIgM22
Administered via IV infusion
Other Name: M22

Primary Outcome Measures :
  1. Safety and tolerability of single ascending doses of the human monoclonal rHIgM22 in patients with MS. [ Time Frame: 90 Days ]
    Monitoring of adverse events (AEs) will be conducted throughout the study. Adverse events, including serious adverse events will be recorded in the case report forms (CRFs).

Secondary Outcome Measures :
  1. Measure the pharmacokinetics (PK) of single ascending doses of rHIgM22 [ Time Frame: Day 1 through Day 180 ]
    PK parameters will include; The maximum measured plasma concentration (Cmax), time to maximum plasma concentration (Tmax), half-life (T1/2), and the area under the concentration curve from time 0 to the concentration at last time point (AUC (0-last)).

  2. Measure the pharmacodynamics of single ascending doses of rHIgM22 using the Expanded Disability Status Scale (EDSS) [ Time Frame: Day 1 through Day 180 ]

Information from the National Library of Medicine

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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

Inclusion Criteria:

  • Able to give written informed consent, with adequate cognitive function to sign the IRBapproved informed consent
  • Meet diagnostic criteria for MS, as defined by revised (2010) McDonald criteria
  • Man or woman aged 18 to 70 years, inclusive
  • Women of childbearing potential must have a negative serum pregnancy test at the Screening Visit and
  • Women of childbearing potential and engaged in heterosexual relations must agree to practice adequate contraception for at least 60 days after study dosing. Women of childbearing potential and not engaged in heterosexual relations or not practicing adequate contraception must agree to remain abstinent for at least 60 days after study dosing practice adequate contraception for the duration of the study
  • Agree to remain in the hospital for the 48 hour post infusion observation period, and can be contacted in case of an emergency once discharged

Exclusion Criteria:

  • Serum creatinine ≥1.5 mg/dL
  • Aspartate aminotransferase (AST), Alanine aminotransferase (ALT) or alkaline phosphatase ≥1.5 times the upper limit of normal
  • Angina, uncontrolled hypertension, clinically significant cardiac arrhythmias (including atrial fibrillation), any other clinically significant cardiovascular abnormality or clinically significant abnormal ECG
  • Immune-mediated disorder other than MS that in the Investigator's judgment, may affect the interpretation of results or the patient's ability to safely complete the study
  • Any clinically significant cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, allergic or anaphylactic reasons, or other major diseases (other than MS), that in the Investigator's judgment, may affect the interpretation of results or patient's ability to safely complete the study. This includes a suicide attempt within the past 1 year or severe suicidal ideation within the past 6 months or patients who in the opinion of the Investigator are at significant risk of suicidal behavior
  • MS relapse within 30 days prior to screening or treatment with systemic (oral, IV or IM) corticosteroids, except for minimally absorbed topical or inhalational preparations, within the 30 days prior to the Screening Visit
  • Initiation of interferon-beta 1b (Betaseron,a extavia), interferon beta-1a (Avonex, a Rebif a), glatiramer acetate (copaxone), natalizumab (Tysabri), or fingolimod (Gilenya), or dimethyl fumarate (Tecfidera ®) within the 90 days prior to the Screening Visit, or any change in the dosing regimen of these drugs within the 30 days prior to the Screening Visit. Initiation of teriflunomide (AUBAGIO®) or any change in the dosing regimen of this drug within 90 days prior to the Screening Visit.
  • Treatment with any of the following medications within the 12 months prior to Day 1 of the study: daclizumab, azathioprine, methotrexate, IV immunoglobulin, plasmaphoresis, or mycophenolate mofetil; or discontinuation of teriflunomide (AUBAGIO®) within 12 months prior to Day 1.
  • History of clinically significant infusion reactions with administration of biologics, including plasma exchange, intravenous immunoglobulin, and other monoclonal antibodies such as natalizumab (Tysabri)
  • Prior treatment with total lymphoid irradiation, T cell or T-cell receptor vaccination, alemtuzumab, mitoxantrone, cyclophosphamide, or rituximab
  • Received any investigational agent or therapy up to 30 days or 4 pharmacokinetic half-lives (whichever is longer) prior to Screening Visit or plans to enroll in another investigational trial at any time during this study
  • Contraindication to brain MRI or inability to tolerate brain MRI

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): NCT01803867

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United States, California
Acorda Investigational Site
Long Beach, California, United States, 90806
Acorda Investigational Site
Palo Alto, California, United States, 04158
Acorda Investigational Site
Sacramento, California, United States, 95817
Acorda Investigational Site
Stanford, California, United States, 94305-5235
United States, Colorado
Acorda Investigational Site
Aurora, Colorado, United States, 80045
Acorda Investigational Site
Centennial, Colorado, United States, 80112
United States, Indiana
Acorda Investigational Site
Indianapolis, Indiana, United States, 46202
United States, Kansas
Acorda Investigational Site
Kansas City, Kansas, United States, 66160
United States, Maryland
Acorda Investigational Site
Baltimore, Maryland, United States, 22125
United States, Missouri
Acorda Investigational Site
St. Louis, Missouri, United States, 63131
United States, New York
Acorda Investigational Site
Rochester, New York, United States, 14642
United States, Rhode Island
Acorda Investigational Site
Providence, Rhode Island, United States, 02905
United States, Tennessee
Acorda Investigational Site
Knoxville, Tennessee, United States, 37920
United States, Texas
Acorda Investigational Site
Dallas, Texas, United States, 75390-9036
United States, Vermont
Acorda Investigational Site
Burlington, Vermont, United States, 05401
United States, Washington
Acorda Investigational Site
Seattle, Washington, United States, 98101
Acorda Investigational Site
Seattle, Washington, United States, 98122
Sponsors and Collaborators
Acorda Therapeutics
PRA Health Sciences
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Study Director: Enrique Carrazana, MD Acorda Therapeutics
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Responsible Party: Acorda Therapeutics
ClinicalTrials.gov Identifier: NCT01803867    
Other Study ID Numbers: IM22-MS-1004
First Posted: March 4, 2013    Key Record Dates
Last Update Posted: February 27, 2015
Last Verified: February 2015
Keywords provided by Acorda Therapeutics:
Multiple Sclerosis
Additional relevant MeSH terms:
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Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases