An Intravenous Infusion Study of rHIgM22 in Patients With Multiple Sclerosis
NCT ID: NCT01803867
Last Updated: 2015-02-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
72 participants
INTERVENTIONAL
2013-03-31
2015-01-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
QUADRUPLE
Study Groups
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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.
rHIgM22
Administered via IV infusion
Interventions
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rHIgM22
Administered via IV infusion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
70 Years
ALL
No
Sponsors
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PRA Health Sciences
INDUSTRY
Acorda Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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Enrique Carrazana, MD
Role: STUDY_DIRECTOR
Acorda Therapeutics
Locations
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Acorda Investigational Site
Long Beach, California, United States
Acorda Investigational Site
Palo Alto, California, United States
Acorda Investigational Site
Sacramento, California, United States
Acorda Investigational Site
Stanford, California, United States
Acorda Investigational Site
Aurora, Colorado, United States
Acorda Investigational Site
Centennial, Colorado, United States
Acorda Investigational Site
Indianapolis, Indiana, United States
Acorda Investigational Site
Kansas City, Kansas, United States
Acorda Investigational Site
Baltimore, Maryland, United States
Acorda Investigational Site
St Louis, Missouri, United States
Acorda Investigational Site
Rochester, New York, United States
Acorda Investigational Site
Providence, Rhode Island, United States
Acorda Investigational Site
Knoxville, Tennessee, United States
Acorda Investigational Site
Dallas, Texas, United States
Acorda Investigational Site
Burlington, Vermont, United States
Acorda Investigational Site
Seattle, Washington, United States
Acorda Investigational Site
Seattle, Washington, United States
Countries
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Other Identifiers
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IM22-MS-1004
Identifier Type: -
Identifier Source: org_study_id