A Study of NeuroVax™, a Therapeutic TCR Peptide Vaccine for SPMS of Multiple Sclerosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-09

Study Completion Date

2023-03-09

Brief Summary

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Multi-center, randomized , double-blind, placebo-controlled , two arm parallel design study of NeuroVax™ vs. Incomplete Freund's Adjuvant ( I F A) placebo. 200 subjects with Secondary Progressive SPMS

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Detailed Description

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Objectives:The primary objective is to compare between treatment groups the cumulative number of new gadolinium enhancing (Gd+) lesions on brain MRI at weeks 24, 32, 40 and 48 i n subjects with secondary progressive MS. Secondary objectives include additional MRI measurements, analyses of clinical relapses, measures of neurologic disability, immunologic evaluations, and safety.

Study Design: Multi-center, randomized , double-blind, placebo-controlled , two arm parallel design study of NeuroVax™ vs. Incomplete Freund's Adjuvant ( I F A) placebo.

Subject Population: 200 subjects with Secondary Progressive SPMS MS, with an EDSS score \>= 3.5 , and meeting all inclusion/exclusion criteria, will be enroll in this study. Subjects will be randomized equally to NeuroVax™ or I F A

,1 0 0 per arm .

Conditions

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Secondary Progress Multiple Sclerosis Multiple Sclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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NeuroVax

Group Type EXPERIMENTAL

NeuroVax

Intervention Type BIOLOGICAL

TCR peptides in IFA

IFA Placebo

Group Type PLACEBO_COMPARATOR

IFA Placebo

Intervention Type BIOLOGICAL

IFA Placebo

Interventions

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NeuroVax

TCR peptides in IFA

Intervention Type BIOLOGICAL

IFA Placebo

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Subject is between 18 and 50 years of age, inclusive.
* Definite MS by the revised McDonald criteria (2005) (Appendix A), with a Secondary Progressive course.
* Expanded Disability Status Scale (EDSS) \>=score 3.5 (Appendix B).
* Two or more documented clinical relapses of MS in the preceding 24 months OR one documented clinical relapse of MS in the preceding 1 2 months prior to screening .
* Laboratory values within the following limits:

* Creatinine 1 . 5 x high normal.
* Hemoglobin

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No