Safety Study of an Immunomodulating Microparticle to Treat Progressive Multiple Sclerosis

NCT01191996 | Completed Phase 1

• 1 other identifier: MIS416-201
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Secondary Progressive Multiple Sclerosis; Primary Progressive Multiple Sclerosis

Keywords

SPMS; PPMS; MS; Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• Safety profile, including maximum tolerated dose

  Dose-limiting toxicities, adverse events, safety MRI assessments

  1 month in DE phase, 3 months in DC phase

Secondary Outcomes (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

• Clinical status

  3 months in DC phase

Study Arms (1)

MIS416

EXPERIMENTAL

MIS416, immunomodulating microparticle, given intravenously weekly

Biological: MIS416

Interventions

MIS416 BIOLOGICAL

MIS416 intravenously every week

MIS416

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Innate Immunotherapeutics: lead
• Primorus Clinical Trials: collaborator
• National Multiple Sclerosis Society: collaborator

Study Sites (1)

Primorus Clinical Trials, 40 Stewart Street

Christchurch, Canterbury, 8011, New Zealand

Location

Related Publications (2)

• 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.

  PMID: 29177070 DERIVED

• 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.

  PMID: 28607691 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis, Chronic Progressive; Multiple Sclerosis

Interventions

MIS416 vaccine

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Alison Luckey

  Primorus Clinical Trials

  PRINCIPAL INVESTIGATOR

• Tim Anderson

  Department of Medicine, University of Otago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2010
• First Posted: August 31, 2010
• Study Start: August 1, 2010
• Primary Completion: June 1, 2012
• Study Completion: November 1, 2012
• Last Updated: December 7, 2012

Record last verified: 2012-12

Locations

NZ (1)