An Intravenous Infusion Study of rHIgM22 in Patients With Multiple Sclerosis

This study is currently recruiting participants.
Verified March 2014 by Acorda Therapeutics
Sponsor:
Collaborator:
PRA International
Information provided by (Responsible Party):
Acorda Therapeutics
ClinicalTrials.gov Identifier:
NCT01803867
First received: February 26, 2013
Last updated: March 6, 2014
Last verified: March 2014
  Purpose

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 Intervention Phase
Multiple Sclerosis
Drug: rHIgM22
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, 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)

Resource links provided by NLM:


Further study details as provided by Acorda Therapeutics:

Primary Outcome Measures:
  • Safety and tolerability of single ascending doses of the human monoclonal rHIgM22 in patients with MS. [ Time Frame: 90 Days ] [ Designated as safety issue: No ]
    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:
  • Measure the pharmacokinetics (PK) of single ascending doses of rHIgM22 [ Time Frame: Day 1 through Day 180 ] [ Designated as safety issue: No ]
    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)).

  • Measure the pharmacodynamics of single ascending doses of rHIgM22 using the Expanded Disability Status Scale (EDSS) [ Time Frame: Day 1 through Day 180 ] [ Designated as safety issue: No ]

Estimated Enrollment: 71
Study Start Date: March 2013
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01803867

Locations
United States, California
Collaborative Neuroscience Network, Inc. Recruiting
Long Beach, California, United States, 90806
Contact: Anne Cabral, MS    562-304-1742    annecabral@cnstrial.com   
Principal Investigator: Nirav Patel, MD         
University of California Davis Medical Center Recruiting
Sacramento, California, United States, 95817
Contact: Janelle Butters    916-734-6276    janelle.butters@ucdmc.ucdavis.edu   
Principal Investigator: Mark Agius, MD         
University of California at San Francisco (UCSF) Recruiting
San Francisco, California, United States, 94143
Contact: Robin Lincoln    415-502-7216    robin.lincoln@ucsf.edu   
Principal Investigator: Bruce Cree, MD         
Stanford University Medical Center Recruiting
Stanford, California, United States, 94305
Contact: Angela Campbell    650-721-6188    ajcampbell@stanford.edu   
Principal Investigator: Alexandra Goodyear, MD         
United States, Colorado
University of Colorado Denver Recruiting
Aurora, Colorado, United States, 80045
Contact: Haley Steinert    303-724-4172    Haley.Steinert@ucdenver.edu   
Principal Investigator: Timothy Vollmer, MD         
IMMUNOe Active, not recruiting
Centennial, Colorado, United States, 80112
United States, Indiana
Indiana University Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Lee Hayward, BSN, RN, MSCN    317-278-7293    lhayward@iupui.edu   
Principal Investigator: David Mattson, MD         
United States, Kansas
University of Kansas Medical Center Active, not recruiting
Kansas City, Kansas, United States, 66160
United States, Maryland
Parexel International Active, not recruiting
Baltimore, Maryland, United States, 21225
United States, Missouri
BJC Medical Group (Missouri Baptist Medical Center) Recruiting
St. Louis, Missouri, United States, 63131
Contact: Delea Payne-Gates    314-996-7775    dxp9466@bjc.org   
Principal Investigator: Mark Tullman, MD         
United States, New York
University of Rochester Medical Center Active, not recruiting
Rochester, New York, United States, 14642
United States, Rhode Island
Rhode Island Hospital Active, not recruiting
Providence, Rhode Island, United States, 02903
United States, Tennessee
New Orleans Center for Clinical Research (NOCCR) Recruiting
Knoxville, Tennessee, United States, 37920
Contact: Debbie Dempsey    865-305-9100    ddempsey@noccr.com   
Principal Investigator: Richard Gibson, MD         
United States, Texas
University of Texas Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390
Contact: Carolyn Kelly, RN    214-648-9312    carolyn.kelly@utsouthwestern.edu   
Principal Investigator: Benjamin M Greenberg, MD         
United States, Vermont
Fletcher Allen Health Care Active, not recruiting
Burlington, Vermont, United States, 05401
United States, Washington
Virginia Mason Medical Center (VMMC) Recruiting
Seattle, Washington, United States, 98101
Contact: Donald Rodriguez, CCRC    206-342-6958    donald.rodriguez@vmmc.org   
Principal Investigator: Mariko Kita, MD         
Multiple Sclerosis Center, Swedish Neuroscience Institute Recruiting
Seattle, Washington, United States, 98122
Contact: Yuriko Courtney, CCRC    206-320-2200    Yuriko.Courtney@Swedish.org   
Principal Investigator: James Bowen, MD         
Sponsors and Collaborators
Acorda Therapeutics
PRA International
Investigators
Study Director: Enrique Carrazana, MD Acorda Therapeutics
  More Information

No publications provided

Responsible Party: Acorda Therapeutics
ClinicalTrials.gov Identifier: NCT01803867     History of Changes
Other Study ID Numbers: IM22-MS-1004
Study First Received: February 26, 2013
Last Updated: March 6, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Acorda Therapeutics:
MS
Multiple Sclerosis

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on April 22, 2014