Safety Study of an Immunomodulating Microparticle to Treat Progressive
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
What it found
A paper reports the results; we have not read it yet. See Papers below.
What was tested
Treatment tested
- MIS416
What it measured
Main measures
Safety profile, including maximum tolerated dose
1 month in DE phase, 3 months in DC phase
MRI lesionsSafety
Other measures (3)
Pharmacodynamic assessments
1 month in DE phase, 3 months in DC phase
MRI assessments
1 month in DE phase, 3 months in DC phase
MRI lesionsSafetyClinical status
3 months in DC phase
Disability progressionFatigueQuality of life (reported by participants)
Who could take part
Progressive MS · 18 and over
Show the full 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.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
Results
Webster GA, Sim DA, La Flamme AC, Mayo NE. Evaluation of neurological changes in secondary progressive multiple sclerosis patients treated with immune modulator MIS416: results from a feasibility study. Pilot Feasibility Stud. 2017 Nov 16;3:60. doi: 10.1186/s40814-017-0201-4. eCollection 2017.Results
Luckey AM, Anderson T, Silverman MH, Webster G. Safety, tolerability and pharmacodynamics of a novel immunomodulator, MIS416, in patients with chronic progressive multiple sclerosis. Mult Scler J Exp Transl Clin. 2015 May 12;1:2055217315583385. doi: 10.1177/2055217315583385. eCollection 2015 Jan-Dec.
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History
Started
Aug 2010
Main results due
Jun 2012
Finished
Nov 2012