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

Last updated: March 9, 2020
Sponsor: Immune Response BioPharma, Inc.
Overall Status: Active - Recruiting

Phase

2/3

Condition

Multiple Sclerosis

Memory Loss

Scar Tissue

Treatment

N/A

Clinical Study ID

NCT02057159
IR902-231
  • Ages 18-50
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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

Study Design

Total Participants: 200
Study Start date:
March 09, 2020
Estimated Completion Date:
March 09, 2023

Study Description

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 .

Connect with a study center

  • CRO

    San Diego, California 92129
    United States

    Active - Recruiting

  • Multiple Sclerosis Center Oregon Health & Science University

    Portland, Oregon 97239
    United States

    Site Not Available

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