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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
Sponsor:
Collaborator:
PRA Health Sciences
Information provided by (Responsible Party):
Acorda Therapeutics

Tracking Information
First Submitted Date  ICMJE February 26, 2013
First Posted Date  ICMJE March 4, 2013
Last Update Posted Date February 27, 2015
Study Start Date  ICMJE March 2013
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 1, 2013)
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).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 14, 2014)
  • 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)).
  • Measure the pharmacodynamics of single ascending doses of rHIgM22 using the Expanded Disability Status Scale (EDSS) [ Time Frame: Day 1 through Day 180 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: March 1, 2013)
Measure the pharmacokinetics (PK) of single ascending doses of rHIgM22 [ Time Frame: Day 1 through Day 60± 7 ]
Serial blood samples will be collected from patients prior to and at specified times for up to 48 hours post treatment for PK assessments. 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)).
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE An Intravenous Infusion Study of rHIgM22 in Patients With Multiple Sclerosis
Official Title  ICMJE A Double-Blind, Placebo-Controlled, Single Ascending Intravenous Infusion Study of Recombinant Human Immunoglobulin M (rHIgM22) in Patients With Multiple Sclerosis (MS)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Multiple Sclerosis
Intervention  ICMJE Drug: rHIgM22
Administered via IV infusion
Other Name: M22
Study Arms  ICMJE 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.

Intervention: Drug: rHIgM22
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 9, 2015)
72
Original Estimated Enrollment  ICMJE
 (submitted: March 1, 2013)
60
Actual Study Completion Date  ICMJE January 2015
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01803867
Other Study ID Numbers  ICMJE IM22-MS-1004
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Acorda Therapeutics
Study Sponsor  ICMJE Acorda Therapeutics
Collaborators  ICMJE PRA Health Sciences
Investigators  ICMJE
Study Director: Enrique Carrazana, MD Acorda Therapeutics
PRS Account Acorda Therapeutics
Verification Date February 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP