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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/NCT01191996




Registration number
NCT01191996
Ethics application status
Date submitted
30/08/2010
Date registered
31/08/2010
Date last updated
7/12/2012

Titles & IDs
Public title
Safety Study of an Immunomodulating Microparticle to Treat Progressive Multiple Sclerosis
Scientific 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
Secondary ID [1] 0 0
MIS416-201
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - MIS416

Experimental: MIS416 - MIS416, immunomodulating microparticle, given intravenously weekly


Other interventions: MIS416
MIS416 intravenously every week
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety profile, including maximum tolerated dose
Timepoint [1] 0 0
1 month in DE phase, 3 months in DC phase
Secondary outcome [1] 0 0
Pharmacodynamic assessments
Timepoint [1] 0 0
1 month in DE phase, 3 months in DC phase
Secondary outcome [2] 0 0
MRI assessments
Timepoint [2] 0 0
1 month in DE phase, 3 months in DC phase
Secondary outcome [3] 0 0
Clinical status
Timepoint [3] 0 0
3 months in DC phase

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

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1/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
1/08/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/11/2012
Sample size
Target
Accrual to date
Final
34
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Canterbury

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Innate Immunotherapeutics
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Primorus Clinical Trials
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
National Multiple Sclerosis Society
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01191996
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Alison Luckey
Address 0 0
Primorus Clinical Trials
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