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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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
Secondary ID [1] 0 0
U1111-1166-0910
Secondary ID [2] 0 0
MIS416-202
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Secondary Progressive Multiple Sclerosis 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - 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


Treatment: Other: MIS416
Intravenous administration weekly for 52 weeks

Treatment: Drugs: Saline
Intravenous administration weekly for 52 weeks
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change from baseline of neuromuscular function at 12 months
Timepoint [1] 0 0
Baseline, 3, 6, 9 and 12 months
Primary outcome [2] 0 0
Proportion of Participants with Serious and Non-Serious Adverse Events
Timepoint [2] 0 0
Up to 12 months
Secondary outcome [1] 0 0
Change from baseline of disability and health status at 12 months
Timepoint [1] 0 0
Baseline, 3, 6, 9, and 12 months
Secondary outcome [2] 0 0
Change from baseline of neurodegeneration by assessing changes in Magnetic Resonance Imaging (MRI) markers at 12 months
Timepoint [2] 0 0
Baseline, 3, and 12 months
Secondary outcome [3] 0 0
Change from baseline of activity of immune biomarkers in serum
Timepoint [3] 0 0
Up to 1 year
Secondary outcome [4] 0 0
Change from baseline of activity of immune biomarkers in cerebrospinal fluid (CSF)
Timepoint [4] 0 0
Up to 12 months
Secondary outcome [5] 0 0
Change from baseline in Peripheral Blood Mononuclear Cell (PBMC) immune biomarkers
Timepoint [5] 0 0
Up to 12 months

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.
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2017
Sample size
Target
Accrual to date
Final
93
Recruitment in Australia
Recruitment state(s)
QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
The Wesley-St. Andrew's Research Institute - Brisbane
Recruitment hospital [2] 0 0
PARC Clinical Research - Adelaide
Recruitment hospital [3] 0 0
Nucleus Network - Centre for Clinical Studies - Melbourne
Recruitment hospital [4] 0 0
Western Australian Neuroscience Research Institute - Perth
Recruitment hospital [5] 0 0
Neurodegenerative Disorders Research - West Perth
Recruitment postcode(s) [1] 0 0
4066 - Brisbane
Recruitment postcode(s) [2] 0 0
5000 - Adelaide
Recruitment postcode(s) [3] 0 0
3004 - Melbourne
Recruitment postcode(s) [4] 0 0
6009 - Perth
Recruitment postcode(s) [5] 0 0
6005 - West Perth
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland
Country [2] 0 0
New Zealand
State/province [2] 0 0
Wellington

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Innate Immunotherapeutics
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Syneos Health
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT02228213
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Michael Silverman
Address 0 0
Innate Immunotherapeutics
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02228213