Safety Study of an Immunomodulating Microparticle to Treat Progressive Multiple Sclerosis

Launched by INNATE IMMUNOTHERAPEUTICS · Aug 30, 2010

Keywords

ClinConnect Summary

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 ...

Gender

ALL

Eligibility 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.