A Study of NeuroVax™, a Therapeutic TCR Peptide Vaccine for SPMS of Multiple Sclerosis
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| ClinicalTrials.gov Identifier: NCT02057159 |
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Recruitment Status :
Not yet recruiting
First Posted : February 6, 2014
Last Update Posted : February 23, 2016
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Secondary Progress Multiple Sclerosis Multiple Sclerosis | Biological: NeuroVax Biological: IFA Placebo | Phase 2 Phase 3 |
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 Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 200 participants |
| Allocation: | Randomized |
| Intervention Model: | Single Group Assignment |
| Masking: | Double (Participant, Investigator) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase II Study of NeuroVax™, a Therapeutic TCR Peptide Vaccine for SPMS of Multiple Sclerosis |
| Study Start Date : | February 2017 |
| Estimated Primary Completion Date : | February 2019 |
| Estimated Study Completion Date : | February 2019 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: NeuroVax
NeuroVax
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Biological: NeuroVax |
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Placebo Comparator: IFA Placebo
IFA Placebo
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Biological: IFA Placebo
IFA Placebo |
- 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 [ Time Frame: up to 48 weeks ]
- Secondary MRI measurements objectives include additional MRI measurements, analyses of clinical relapses, measures of neurologic disability, immunologic evaluations, and safety. [ Time Frame: 48 Weeks ]Secondary MRI measurements
- Analyses of clinical relapses [ Time Frame: 48 Weeks ]Analyses of clinical relapses
- Measures of neurologic disability EDSS score [ Time Frame: 48 Weeks ]Measures of neurologic disability EDSS score
- Immunologic evaluations [ Time Frame: 48 Weeks ]Immunologic evaluations
- Safety [ Time Frame: 48 Weeks ]Safety
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| Ages Eligible for Study: | 18 Years to 50 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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 .
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Laboratory values within the following limits:
- Creatinine 1 . 5 x high normal.
- Hemoglobin
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02057159
| Contact: Richard M Bartholomew, Ph.D | 1-858-414-4664 | Richardmbartholomew@gmail.com |
| United States, Oregon | |
| Multiple Sclerosis Center Oregon Health & Science University | Not yet recruiting |
| Portland, Oregon, United States, 97239 | |
| Contact: Richard M Bartholomew, PhD 1-858-414-4664 Richardmbartholomew@gmail.com | |
| Principal Investigator: Dennis Bourdette, F.A.A.N. M.D. | |
| Study Director: | Richard M Bartholomew, Ph.D | Immune Response BioPharma, Inc. |
Additional Information:
| Responsible Party: | Immune Response BioPharma, Inc. |
| ClinicalTrials.gov Identifier: | NCT02057159 History of Changes |
| Other Study ID Numbers: |
IR902-231 |
| First Posted: | February 6, 2014 Key Record Dates |
| Last Update Posted: | February 23, 2016 |
| Last Verified: | February 2016 |
Keywords provided by Immune Response BioPharma, Inc.:
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Secondary Progress Multiple Sclerosis SPMS Multiple Sclerosis NeuroVax |
Additional relevant MeSH terms:
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Sclerosis Multiple Sclerosis Pathologic Processes Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System |
Nervous System Diseases Demyelinating Diseases Autoimmune Diseases Immune System Diseases |