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

Multiple Sclerosis Clinical Trial

Official title:

A Phase IIb Study of NeuroVax™, a Novel Therapeutic TCR Peptide Vaccine for SPMS of Multiple Sclerosis Slowing Disease Progression Via Vaccination

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02149706
• Other study ID #: Immune Response 2020
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: March 9, 2020
• Est. completion date: March 9, 2022

Study information

• Verified date: March 2020
• Source: Immune Response BioPharma, Inc.
• Contact: Richard M Bartholomew, Ph.D
• Phone: 1-858-414-4664
• Email: Richardmbartholomew[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: March 9, 2022
• Est. primary completion date: March 9, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Biological:
• NeuroVax
NeuroVax consists of a Trivalent TCR Peptide Formulation in IFA
• IFA Incomplete Freund's Adjuvant
IFA Placebo Incomplete Freund's Adjuvant

Locations

Country	Name	City	State
United States	CRO	San Diego	California

Sponsors (2)

Lead Sponsor	Collaborator
Immune Response BioPharma, Inc.	cro

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary objective is to compare between treatment groups the Measures of neurologic disability EDSS score	The primary objective is to compare between treatment groups the Measures of neurologic disability EDSS scores improvements	48 Weeks
Secondary	Secondary measurements objectives immunologic evaluations	Secondary measurements objectives immunologic evaluations increases in white blood cell counts & FOXP+3 expression increases	48 Weeks

External Links

•   Immune Response BioPharma, Inc.