Trial Search Results

An Intravenous Infusion Study of rHIgM22 in Patients With Multiple Sclerosis

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.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Acorda Therapeutics

Collaborator: PRA Health Sciences

Stanford Investigator(s):

Intervention(s):

  • Drug: rHIgM22

Phase:

Phase 1

Eligibility


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

Ages Eligible for Study

18 Years - 70 Years

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Julia Buckingham
(650) 725-7545
Not Recruiting