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

Phase 2

• Conditions: Multiple Sclerosis
• Interventions: Biological: IFA Incomplete Freund's Adjuvant; Biological: NeuroVax

• Registration Number: NCT02149706
• Lead Sponsor: Immune Response BioPharma, Inc.

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. 150 subjects with Secondary Progressive SPMS.

Detailed Description

The primary objective is to compare between treatment groups the Measures of neurologic disability EDSS scores.

Study Timeline

• Study First Submitted: 2014-05-24
• Study First Submitted QC: 2014-05-28
• Study First Posted: 2014-05-29
• Status Verified: 2020-03
• Study Start: 2020-03-09
• Last Update Submitted: 2020-03-09
• Last Update Posted: 2020-03-11
• Primary Completion: 2022-03-09
• Study Completion: 2022-03-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Genders Eligible for Study: Both
• Accepts Healthy Volunteers: No Criteria
• Subject is between 18 and 70 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

Exclusion Criteria

• Subjects currently prescribed Campath or Lemtrada

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IFA Incomplete Freund's Adjuvant	IFA Incomplete Freund's Adjuvant	Incomplete Freund's Adjuvant IFA
NeuroVax	NeuroVax	NeuroVax

Primary Outcome Measures

Name	Time	Method
The primary objective is to compare between treatment groups the Measures of neurologic disability EDSS score	48 Weeks	The primary objective is to compare between treatment groups the Measures of neurologic disability EDSS scores improvements

Secondary Outcome Measures

Name	Time	Method
Secondary measurements objectives immunologic evaluations	48 Weeks	Secondary measurements objectives immunologic evaluations increases in white blood cell counts \& FOXP+3 expression increases

Trial Locations

Locations (1)

CRO; 🇺🇸 San Diego, California, United States