A Study of NeuroVax™, a Therapeutic TCR Peptide Vaccine for SPMS of Multiple Sclerosis
Study Details
Study Description
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
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 2/Phase 3 |
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 Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: NeuroVax NeuroVax |
Biological: NeuroVax
TCR peptides in IFA
|
Placebo Comparator: IFA Placebo IFA Placebo |
Biological: IFA Placebo
IFA Placebo
|
Outcome Measures
Primary Outcome Measures
- 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
- 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
- Immunologic evaluations [48 Weeks]
Immunologic evaluations
- Safety Evaluation [48 Weeks]
Safety Evaluation
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | CRO | San Diego | California | United States | 92129 |
Sponsors and Collaborators
- Immune Response BioPharma, Inc.
- cro
Investigators
- Study Director: Richard M Bartholomew, Ph.D, Immune Response BioPharma, Inc.
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- IR902-231