A Study of NeuroVax™, a Therapeutic TCR Peptide Vaccine for SPMS of Multiple Sclerosis
A Phase II Study of NeuroVax™, a Therapeutic TCR Peptide Vaccine for SPMS of Multiple Sclerosis
1 other identifier
interventional
200
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Mar 2020
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 4, 2014
CompletedFirst Posted
Study publicly available on registry
February 6, 2014
CompletedStudy Start
First participant enrolled
March 9, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 9, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 9, 2023
CompletedMarch 11, 2020
March 1, 2020
3 years
February 4, 2014
March 9, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
Secondary MRI measurements objectives include additional MRI measurements, analyses of clinical relapses, measures of neurologic disability, immunologic evaluations, and safety.
48 Weeks
Analyses of clinical relapses
48 Weeks
Measures of neurologic disability EDSS score
48 Weeks
Immunologic evaluations
48 Weeks
Safety Evaluation
48 Weeks
Study Arms (2)
NeuroVax
EXPERIMENTALNeuroVax
IFA Placebo
PLACEBO COMPARATORIFA Placebo
Interventions
Eligibility Criteria
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Immune Response BioPharma, Inc.lead
- crocollaborator
Study Sites (1)
CRO
San Diego, California, 92129, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Richard M Bartholomew, Ph.D
Immune Response BioPharma, Inc.
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 4, 2014
First Posted
February 6, 2014
Study Start
March 9, 2020
Primary Completion
March 9, 2023
Study Completion
March 9, 2023
Last Updated
March 11, 2020
Record last verified: 2020-03