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

Phase 2

• Conditions: Multiple Sclerosis; Secondary Progress Multiple Sclerosis
• Interventions: Biological: IFA Placebo; Biological: NeuroVax

• Registration Number: NCT02057159
• 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. 200 subjects with Secondary Progressive SPMS

Detailed 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 .

Study Timeline

• Study First Submitted: 2014-02-04
• Study First Submitted QC: 2014-02-05
• Study First Posted: 2014-02-06
• Status Verified: 2020-03
• Study Start: 2020-03-09
• Last Update Submitted: 2020-03-09
• Last Update Posted: 2020-03-11
• Primary Completion: 2023-03-09
• Study Completion: 2023-03-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
IFA Placebo	IFA Placebo	IFA Placebo
NeuroVax	NeuroVax	NeuroVax

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Immunologic evaluations	48 Weeks	Immunologic evaluations
Safety Evaluation	48 Weeks	Safety Evaluation
Secondary MRI measurements objectives include additional MRI measurements, analyses of clinical relapses, measures of neurologic disability, immunologic evaluations, and safety.	48 Weeks	Secondary MRI measurements
Analyses of clinical relapses	48 Weeks	Analyses of clinical relapses
Measures of neurologic disability EDSS score	48 Weeks	Measures of neurologic disability EDSS score

Trial Locations

Locations (1)

CRO; 🇺🇸 San Diego, California, United States