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Safety Study of an Immunomodulating Microparticle to Treat Progressive Multiple Sclerosis

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ClinicalTrials.gov Identifier: NCT01191996
Recruitment Status : Completed
First Posted : August 31, 2010
Last Update Posted : December 7, 2012
Sponsor:
Collaborators:
Primorus Clinical Trials
National Multiple Sclerosis Society
Information provided by (Responsible Party):
Innate Immunotherapeutics

Study Description
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Brief Summary:
The purpose of the study is to determine the safety and tolerability, dose-limiting toxicities, maximum tolerated dose, and recommended therapeutic dose of intravenously administered MIS416 weekly in patients with chronic progressive multiple sclerosis.

Condition or disease Intervention/treatment Phase
Secondary Progressive Multiple Sclerosis Primary Progressive Multiple Sclerosis Biological: MIS416 Phase 1 Phase 2

Detailed Description:

This is a single center, open-label, non-randomized, dose-escalation study, to be conducted in two phases:

  • a dose-escalation (DE) phase, to evaluate the safety, tolerability, MTD, and PD of MIS416 administered IV once weekly for 4 doses; and
  • a dose-confirmation (DC) phase, which will be a cohort expansion at or below the MTD (i.e., the RTD) of MIS416, dosed once weekly for up to 12 doses.

Subjects will be treated with a weekly IV dose of MIS416 in 28-day cycles: 1 cycle in the DE phase, and up to 3 cycles in the DC phase. Subjects will be evaluated and dosed weekly each cycle in each phase. Subjects will return for a follow-up visit 7 days after completion of the last dose of study drug.

The primary objectives of this study are:

  1. To determine the safety and tolerability, dose-limiting toxicities (DLTs), maximum tolerated dose (MTD), and recommended therapeutic dose (RTD) of intravenously (IV) administered MIS416 weekly in patients with chronic progressive multiple sclerosis (CPMS); and
  2. To assess the pharmacodynamic (PD) effects of MIS416, including effects on serum cytokine levels and peripheral blood mononuclear cell (PBMC) composition, cytokine/chemokine expression and function.

The secondary objectives of this study are:

  1. To document any changes in MS clinical status occurring during the 12-week MIS416 dosing period in the dose-confirmation phase, as determined by the Multiple Sclerosis Functional Composite (MSFC), Fatigue Severity Scale (FSS), Short Form Health Survey (SF-36), and Expanded Disability Status Scale (EDSS); the frequency of clinical relapses; and signs of clinical activity on serial cranial MRI scans; and
  2. To evaluate, in exploratory fashion, any correlations between clinical, radiological and PD outcomes.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2, Open-label, Dose-escalation Study Evaluating the Safety, Tolerability, and Pharmacodynamics of Intravenously Administered MIS416 in Patients With Chronic Progressive Multiple Sclerosis
Study Start Date : August 2010
Actual Primary Completion Date : June 2012
Actual Study Completion Date : November 2012

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Arms and Interventions
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Arm Intervention/treatment
Experimental: MIS416
MIS416, immunomodulating microparticle, given intravenously weekly
 Biological: MIS416
MIS416 intravenously every week


Outcome Measures
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Primary Outcome Measures :
  1. Safety profile, including maximum tolerated dose [ Time Frame: 1 month in DE phase, 3 months in DC phase ]
    Dose-limiting toxicities, adverse events, safety MRI assessments


Secondary Outcome Measures :
  1. Pharmacodynamic assessments [ Time Frame: 1 month in DE phase, 3 months in DC phase ]
    Serum and cellular immunological assays

  2. MRI assessments [ Time Frame: 1 month in DE phase, 3 months in DC phase ]
    Safety MRIs

  3. Clinical status [ Time Frame: 3 months in DC phase ]
    Neurological examination, Expanded Disability Status Scale (EDSS), Multiple Sclerosis Functional Composite (MSFC), Fatigue Severity Scale (FSS), Multiple Sclerosis Quality of Life (MSQLI).


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • At least 18 years of age.
  • Diagnosis of MS, by the McDonald criteria.
  • Chronic progressive MS (CPMS), defined as either primary progressive MS (PPMS) or secondary progressive MS (SPMS), per the criteria of the National Multiple Sclerosis Society (USA) Advisory Committee on Clinical Trials of New Agents in Multiple Sclerosis. [NOTE: In the dose-confirmation phase, only subjects with SPMS may be enrolled].
  • MS is clinically active with worsening clinical status within the past 2 years, defined as an increase in EDSS by 1 point or more, sustained for at least 6 months.
  • Expanded Disability Status Scale (EDSS) of 2.5 to 7.0 at Screening.

  • The following laboratory values must be documented within 3 days prior to initiation of study drug:

    • Absolute neutrophil count (ANC) >= 1 x 109/L
    • Platelet count >= 100 x 109/L
    • Serum creatinine =< 1.5 mg/dL
    • AST (SGOT) and ALT (SGPT) =< 2 × upper limit of normal.
  • Provide written informed consent to participate.

Exclusion Criteria:

  • Relapsing-remitting MS or progressive-relapsing MS
  • Any immunomodulatory drug therapy or immunosuppressive therapy within the previous six months, or vaccine or systemic corticosteroids within the previous 60 days, prior to initiation of study drug.
  • Exposure to other experimental treatments currently under investigation in MS clinical trials, including alemtuzamab, rituximab, fingolimod, and clabribine.
  • A diagnosis or history of collagen vascular disease (including Sjögren's syndrome and systemic lupus erythematosus), anticardiolipin antibody syndrome, cerebral autosomal dominant arteriopathy with subcortical infarcts and leukoencephalopathy (CADASIL), sarcoidosis, vasculitis, Bechet's syndrome and/or Lyme disease.
  • History of alcohol or drug abuse (with the exception of cannabinoids) within 2 years prior to initiation of study drug.
  • Previous exposure to MIS416.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01191996


Locations
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New Zealand
Primorus Clinical Trials, 40 Stewart Street
Christchurch, Canterbury, New Zealand, 8011
Sponsors and Collaborators
Innate Immunotherapeutics
Primorus Clinical Trials
National Multiple Sclerosis Society
Investigators
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Principal Investigator: Alison Luckey Primorus Clinical Trials
Principal Investigator: Tim Anderson Department of Medicine, University of Otago
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Innate Immunotherapeutics
ClinicalTrials.gov Identifier: NCT01191996    
Other Study ID Numbers: MIS416-201
First Posted: August 31, 2010    Key Record Dates
Last Update Posted: December 7, 2012
Last Verified: December 2012
Keywords provided by Innate Immunotherapeutics:
SPMS
PPMS
MS
Multiple Sclerosis
Additional relevant MeSH terms:
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Multiple Sclerosis
Multiple Sclerosis, Chronic Progressive
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
 Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases