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

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02057159
• Other study ID #: IR902-231
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: March 9, 2020
• Est. completion date: March 9, 2023

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. 200 subjects with Secondary Progressive SPMS

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 .

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: March 9, 2023
• Est. primary completion date: March 9, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis
• Secondary Progress Multiple Sclerosis

Intervention

Biological:
• NeuroVax
TCR peptides in IFA
• IFA Placebo
IFA Placebo

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 cumulative number of new gadolinium enhancing (Gd+) lesions on brain MRI at up to 48 weeks in subjects with secondary progressive MS		up to 48 weeks
Secondary	Secondary MRI measurements objectives include additional MRI measurements, analyses of clinical relapses, measures of neurologic disability, immunologic evaluations, and safety.	Secondary MRI measurements	48 Weeks
Secondary	Analyses of clinical relapses	Analyses of clinical relapses	48 Weeks
Secondary	Measures of neurologic disability EDSS score	Measures of neurologic disability EDSS score	48 Weeks
Secondary	Immunologic evaluations	Immunologic evaluations	48 Weeks
Secondary	Safety Evaluation	Safety Evaluation	48 Weeks

External Links

•   Immune Response BioPharma,Inc.