An Intravenous Infusion Study of rHIgM22 in Patients With Multiple Sclerosis



Status:Completed
Conditions:Neurology, Multiple Sclerosis
Therapuetic Areas:Neurology, Other
Healthy:No
Age Range:18 - 70
Updated:5/5/2014
Start Date:March 2013
End Date:September 2014

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A Double-Blind, Placebo-Controlled, Single Ascending Intravenous Infusion Study of Recombinant Human Immunoglobulin M (rHIgM22) in Patients With Multiple Sclerosis (MS)

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.


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
We found this trial at
17
sites
500 Parnassus Ave
San Francisco, California 94143
(415) 476-9000
University of California at San Francisco (UCSF) The leading university exclusively focused on health, UC...
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425 University Blvd.
Indianapolis, Indiana 46202
(317) 274-4591
Indiana University INDIANA UNIVERSITY is a major multi-campus public research institution, grounded in the liberal...
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Indianapolis, IN
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593 Eddy Street
Providence, Rhode Island 02903
401-444-4000
Rhode Island Hospital Founded in 1863, Rhode Island Hospital in Providence, RI, is a private,...
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Providence, RI
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601 Elmwood Avenue
Rochester, New York 14642
(585) 275-2100
Univ of Rochester Medical Center One of the nation's top academic medical centers, the University...
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Rochester, NY
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13001 E. 17th Pl
Aurora, Colorado 80045
303-724-5000
University of Colorado Denver The University of Colorado Denver | Anschutz Medical Campus provides a...
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Baltimore, Maryland 22125
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111 Colchester Ave
Burlington, Vermont 05401
(802) 847-0000
Fletcher Allen Health Care As Vermont’s University Medical Center, we at Fletcher Allen are committed...
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Centennial, Colorado 80112
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1801 Inwood Rd
Dallas, Texas 75390
(214) 645-3300
University of Texas Southwestern Medical Center UT Southwestern is an academic medical center, world-renowned for...
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3901 Rainbow Blvd
Kansas City, Kansas 66160
(913) 588-5000
University of Kansas Medical Center The University of Kansas Medical Center serves Kansas through excellence...
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Knoxville, TN
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Long Beach, California 90806
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2315 Stockton Blvd.
Sacramento, California 95817
(916) 734-2011
University of California, Davis Medical Center UC Davis Medical Center serves a 65,000-square-mile area that...
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Seattle, Washington 98101
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300 Pasteur Dr
Stanford, California 94305
(650) 723-4000
Stanford Univ Med Ctr The Medical Center is uniquely advantaged by its location on the...
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Stanford, CA
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