Recruiting
Phase 2
Phase 3

NeuroVax™

Sponsor:

Immune Response BioPharma, Inc.

Code:

NCT02057159

Conditions

Secondary Progress Multiple Sclerosis

Multiple Sclerosis

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Not accepted

Interventions

NeuroVax

IFA Placebo

Study Details

Brief 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

Conditions

Secondary Progress Multiple Sclerosis

Multiple Sclerosis

Study ID

NCT02057159

Start date

Mar 9, 2020

Status verified date

Mar, 2020

Completion date

Mar 9, 2023

Anticipated

Primary completion date

Mar 9, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Not accepted

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

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: NeuroVax

NeuroVax

placebo comparator: IFA Placebo

IFA Placebo

Interventions

NeuroVax

TCR peptides in IFA

IFA Placebo

IFA Placebo

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Richard M Bartholomew, Ph.D

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

Locations

CRO

Recruiting

San Diego, California, United States, 92129

Contacts

Richard M Bartholomew, PhD

858-414-4664Richardmbartholomew@gmail.com

Principal Investigator:

Richard Bartholomew, Phd

More Information

Sponsor

Immune Response BioPharma, Inc.

Last update posted

Mar 11, 2020

Last verified

Mar, 2020

Keywords

  • Secondary Progress Multiple Sclerosis
  • SPMS
  • Multiple Sclerosis
  • NeuroVax

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Immune Response BioPharma, Inc. on 2020-03-11.