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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02228213
Registration number
NCT02228213
Ethics application status
Date submitted
21/08/2014
Date registered
28/08/2014
Date last updated
14/07/2017
Titles & IDs
Public title
Safety and Efficacy Study of MIS416 to Treat Secondary Progressive Multiple Sclerosis
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Scientific title
A Phase 2B Randomised, Double-Blind, Placebo-Controlled Trial of the Efficacy and Safety of MIS416 in the Treatment of Subjects With Secondary Progressive Multiple Sclerosis
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Secondary ID [1]
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U1111-1166-0910
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Secondary ID [2]
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MIS416-202
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Secondary Progressive Multiple Sclerosis
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - MIS416
Treatment: Drugs - Saline
Experimental: Treatment - 500 mcg MIS416 500 at 0.2 mg/mL administered i.v. once weekly for 52 weeks
Placebo Comparator: Saline - Saline administered i.v. once weekly for 52 weeks
Other interventions: MIS416
Intravenous administration weekly for 52 weeks
Treatment: Drugs: Saline
Intravenous administration weekly for 52 weeks
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Intervention code [1]
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Other interventions
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Intervention code [2]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change from baseline of neuromuscular function at 12 months
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Assessment method [1]
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Neuromuscular function will be assessed using the following test:
MS Function Composite (MSFC), comprising the; timed 25 Foot Walk, 9 Hole Peg Test (9HPT), and Paced Auditory Serial Addition Test (PASAT);
Jebsen Hand Function Test (JHFT);
Grip, tip and key pinch strength;
Symbol digit modalities test (SDMT);
Sloan low-contrast letter visual acuity (SLCVA);
6-minute walk test (6MWT);
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Timepoint [1]
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Baseline, 3, 6, 9 and 12 months
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Primary outcome [2]
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Proportion of Participants with Serious and Non-Serious Adverse Events
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Assessment method [2]
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Safety assessments will be conducted at each study visit and include; characterization of the type, incidence, severity, timing, seriousness, and relationship to treatment of adverse events (AEs); effects on vital signs and clinical laboratory parameters; changes on electrocardiograms (ECGs); and at 3 months and 12 months - the number of gadolinium-enhancing lesions on cranial MRI assessments.
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Timepoint [2]
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Up to 12 months
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Secondary outcome [1]
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Change from baseline of disability and health status at 12 months
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Assessment method [1]
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Disability and health status will be assessed using the following assessments and patient reported outcomes:
Expanded Disability Status Scale (EDSS)
Patient Reported Outcomes (PROs) including;
SF-36 and its components;
MS Impact Scale (MSIS-29);
Neurological Fatigue Index for MS (NFI-MS);
Brief Pain Inventory (BPI).
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Timepoint [1]
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Baseline, 3, 6, 9, and 12 months
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Secondary outcome [2]
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Change from baseline of neurodegeneration by assessing changes in Magnetic Resonance Imaging (MRI) markers at 12 months
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Assessment method [2]
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Disease activity and neurodegeneration will be assessing using Magnetic Resonance Imaging (MRI) markers including lesions, whole brain atrophy (WBA) and Magnetization Transfer Ratio (MTR).
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Timepoint [2]
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Baseline, 3, and 12 months
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Secondary outcome [3]
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Change from baseline of activity of immune biomarkers in serum
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Assessment method [3]
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The effect on immune biomarkers will include the analysis of serum for some or all of the following markers: IP-10 (CXCL10), MCP-1 (CCL2), MIG (CXCL9), IL-8 (CXCL8), IFN?, Neopterin, IL-1RA, sTNF-R, IL-12/23, p40, CD62E (E-selectin), CD54 (ICAM-1), and CD106 (VCAM-1).
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Timepoint [3]
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Up to 1 year
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Secondary outcome [4]
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Change from baseline of activity of immune biomarkers in cerebrospinal fluid (CSF)
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Assessment method [4]
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The effect on immune biomarkers will include the analysis of CSF for some or all of the following markers: IP-10 (CXCL10), MCP-1 (CCL2), MIG (CXCL9), IL-8 (CXCL8), IFN?, Neopterin, IL-1RA, sTNF-R, IL-12/23, p40, CD62E (E-selectin), CD54 (ICAM-1), and CD106 (VCAM-1).
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Timepoint [4]
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Up to 12 months
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Secondary outcome [5]
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Change from baseline in Peripheral Blood Mononuclear Cell (PBMC) immune biomarkers
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Assessment method [5]
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Some or all of these biomarkers may be assayed ex vivo: PBMC expression of mRNA encoding proteins involved in myeloid differentiation and immune regulatory function (e.g. VEGF, Arginine, INOS, IL-10, MMP9); PBMC myeloid subset production of IL-10, TGFß, IL-6, TNFa, IL-1ß, IFN?, IL-17, and GM-CSF in response to stimulation with LPS, LPS/IFN? or MIS416 ex vivo; and PBMC subset analysis of myeloid and dendritic cell subsets for immunoregulatory cell subset markers.
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Timepoint [5]
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Up to 12 months
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Eligibility
Key inclusion criteria
1. A historical or current cranial MRI scan demonstrating T2-hyperintense lesions
consistent with MS.
2. Has SPMS as determined by the 2010 Update to the McDonald Criteria
3. An Expanded Disability Status Scale (EDSS) of 3.0 to 6.5 at Screening.
4. Has SPMS which, in the judgment of the investigator, has been clinically active and
functionally progressive within the 2 years prior to Screening
5. The absence of MS relapse for at least two years prior to Baseline.
6. Neurologically stable for at least four weeks prior to Screening.
7. 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.
8. Provided written informed consent to participate.
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Minimum age
18
Years
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Maximum age
70
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Has primary Progressive MS (PPMS), Relapsing Remitting (RRMS), or progressive
relapsing MS as determined by the 2010 update to the McDonald Criteria.
2. Has not completed the discontinuation period for approved and/or investigational
multiple sclerosis disease modifying therapies prior to screening.
3. 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.
4. Any previous exposure to investigational MS therapeutic vaccines.
5. Any use of cell-depleting monoclonal antibodies including, but not limited to,
Rituximab, or Ocrelizumab.
6. 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.
7. Contraindication to MRI (e.g., pacemaker or other contraindicated implanted metal
device, allergy to gadolinium, or unmanageable claustrophobia).
8. A history of alcohol or drug abuse (including cannabinoid use) within two years prior
to Screening.
9. Has had major surgery or radiation therapy within four weeks prior to Screening.
10. Has an active infection requiring antibiotics within two weeks prior to Screening.
11. Has had active malignancy within two years of Screening, with the exception of basal
cell carcinoma and squamous cell carcinoma of the skin.
12. Uncontrolled congestive heart failure, myocardial infarction, cerebrovascular
accident, coronary/peripheral artery bypass graft surgery, or transient ischemic
attack within twelve weeks prior to Screening.
13. Has angina, other symptomatic coronary artery disease, or known cardiomyopathy.
14. Has symptomatic cardiac dysrhythmias requiring treatment, or persistent prolongation
of the QTcF (Fredericia) interval to > 450 msec for males or > 470 msec for females.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/10/2014
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/06/2017
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Sample size
Target
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Accrual to date
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Final
93
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Recruitment in Australia
Recruitment state(s)
QLD,SA,VIC,WA
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Recruitment hospital [1]
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The Wesley-St. Andrew's Research Institute - Brisbane
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Recruitment hospital [2]
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PARC Clinical Research - Adelaide
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Recruitment hospital [3]
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Nucleus Network - Centre for Clinical Studies - Melbourne
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Recruitment hospital [4]
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Western Australian Neuroscience Research Institute - Perth
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Recruitment hospital [5]
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Neurodegenerative Disorders Research - West Perth
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Recruitment postcode(s) [1]
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4066 - Brisbane
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Recruitment postcode(s) [2]
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5000 - Adelaide
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Recruitment postcode(s) [3]
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3004 - Melbourne
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Recruitment postcode(s) [4]
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6009 - Perth
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Recruitment postcode(s) [5]
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6005 - West Perth
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Recruitment outside Australia
Country [1]
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New Zealand
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State/province [1]
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Auckland
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Country [2]
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New Zealand
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State/province [2]
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Wellington
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Innate Immunotherapeutics
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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Syneos Health
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
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 multiple sclerosis.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02228213
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Michael Silverman
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Address
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Innate Immunotherapeutics
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02228213
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