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

Phase 3UnknownNCT02057159

Immune Response BioPharma, Inc.200 enrolled

Overview

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

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 .

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

200

Conditions

Secondary Progress Multiple Sclerosis Multiple Sclerosis

Interventions

NeuroVaxBIOLOGICAL

TCR peptides in IFA

IFA PlaceboBIOLOGICAL

IFA Placebo

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 Years

Medical Language ↔ Plain English

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

Locations (1)

CRO

San Diego, California, United States

RECRUITING

Outcomes

Primary Outcomes

The primary objective is to compare between treatment groups the cumulative number of new gadolinium enhancing (Gd+) lesions on brain MRI at up to 48 weeks in subjects with secondary progressive MS

Time frame: up to 48 weeks

Secondary Outcomes

Secondary MRI measurements objectives include additional MRI measurements, analyses of clinical relapses, measures of neurologic disability, immunologic evaluations, and safety.

Secondary MRI measurements

Time frame: 48 Weeks

Analyses of clinical relapses

Time frame: 48 Weeks

Measures of neurologic disability EDSS score

Time frame: 48 Weeks

Immunologic evaluations

Time frame: 48 Weeks

Safety Evaluation

Time frame: 48 Weeks

Central Contacts

Richard M Bartholomew, Ph.D

CONTACT

1-858-414-4664 Richardmbartholomew@gmail.com

Data from ClinicalTrials.gov

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