Status:
COMPLETED
Safety and Efficacy Study of MIS416 to Treat Secondary Progressive Multiple Sclerosis
Lead Sponsor:
Innate Immunotherapeutics
Collaborating Sponsors:
Syneos Health
Conditions:
Secondary Progressive Multiple Sclerosis
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine whether MIS416 administered once weekly over 12 months is safe, tolerable, and improves a range of signs and symptoms associated with secondary progressive mu...
Detailed Description
The primary objectives of the study are to: 1. Determine the efficacy of MIS416, relative to placebo, when administered repeatedly via weekly intravenous (IV) administration to subjects with Secondar...
Eligibility Criteria
Inclusion
- A historical or current cranial MRI scan demonstrating T2-hyperintense lesions consistent with MS.
- Has SPMS as determined by the 2010 Update to the McDonald Criteria
- An Expanded Disability Status Scale (EDSS) of 3.0 to 6.5 at Screening.
- Has SPMS which, in the judgment of the investigator, has been clinically active and functionally progressive within the 2 years prior to Screening
- The absence of MS relapse for at least two years prior to Baseline.
- Neurologically stable for at least four weeks prior to Screening.
- Has the following laboratory values within three days prior to initiation of Investigational Product:
- Absolute neutrophil count (ANC) \>= 1 x 109/L;
- Platelet count \>= 100 x 109/L;
- Serum creatinine =\< 1.5 mg/dL;
- Aspartate aminotransferase (AST) =\<2 × upper limit of normal;
- Alanine aminotransferase (ALT) =\< 2 × upper limit of normal.
- Provided written informed consent to participate.
Exclusion
- Has primary Progressive MS (PPMS), Relapsing Remitting (RRMS), or progressive relapsing MS as determined by the 2010 update to the McDonald Criteria.
- Has not completed the discontinuation period for approved and/or investigational multiple sclerosis disease modifying therapies prior to screening.
- Has had any other immunomodulatory drug therapy or immunosuppressive therapy within four weeks prior to Screening, or systemic corticosteroids within the eight weeks prior to Screening.
- Any previous exposure to investigational MS therapeutic vaccines.
- Any use of cell-depleting monoclonal antibodies including, but not limited to, Rituximab, or Ocrelizumab.
- 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, sarcoidosis, vasculitis, Behcet's syndrome and/or Lyme disease.
- Contraindication to MRI (e.g., pacemaker or other contraindicated implanted metal device, allergy to gadolinium, or unmanageable claustrophobia).
- A history of alcohol or drug abuse (including cannabinoid use) within two years prior to Screening.
- Has had major surgery or radiation therapy within four weeks prior to Screening.
- Has an active infection requiring antibiotics within two weeks prior to Screening.
- Has had active malignancy within two years of Screening, with the exception of basal cell carcinoma and squamous cell carcinoma of the skin.
- Uncontrolled congestive heart failure, myocardial infarction, cerebrovascular accident, coronary/peripheral artery bypass graft surgery, or transient ischemic attack within twelve weeks prior to Screening.
- Has angina, other symptomatic coronary artery disease, or known cardiomyopathy.
- Has symptomatic cardiac dysrhythmias requiring treatment, or persistent prolongation of the QTcF (Fredericia) interval to \> 450 msec for males or \> 470 msec for females.
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2017
Estimated Enrollment :
93 Patients enrolled
Trial Details
Trial ID
NCT02228213
Start Date
October 1 2014
End Date
June 1 2017
Last Update
July 14 2017
Active Locations (7)
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1
The Wesley-St. Andrew's Research Institute
Brisbane, Queensland, Australia, 4066
2
PARC Clinical Research
Adelaide, South Australia, Australia, 5000
3
Nucleus Network - Centre for Clinical Studies
Melbourne, Victoria, Australia, 3004
4
Western Australian Neuroscience Research Institute
Perth, Western Australia, Australia, 6009