A Study of NeuroVax™, a Novel Therapeutic TCR Peptide Vaccine for SPMS of Multiple Sclerosis
A Phase IIb Study of NeuroVax™, a Novel Therapeutic TCR Peptide Vaccine for SPMS of Multiple Sclerosis Slowing Disease Progression Via Vaccination
1 other identifier
interventional
150
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. 150 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 multiple-sclerosis
Started Mar 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 24, 2014
CompletedFirst Posted
Study publicly available on registry
May 29, 2014
CompletedStudy Start
First participant enrolled
March 9, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 9, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 9, 2022
CompletedMarch 11, 2020
March 1, 2020
2 years
May 24, 2014
March 9, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The primary objective is to compare between treatment groups the Measures of neurologic disability EDSS score
The primary objective is to compare between treatment groups the Measures of neurologic disability EDSS scores improvements
48 Weeks
Secondary Outcomes (1)
Secondary measurements objectives immunologic evaluations
48 Weeks
Study Arms (2)
NeuroVax
EXPERIMENTALNeuroVax
IFA Incomplete Freund's Adjuvant
PLACEBO COMPARATORIncomplete Freund's Adjuvant IFA
Interventions
IFA Placebo Incomplete Freund's Adjuvant
Eligibility Criteria
You may qualify if:
- Ages Eligible for Study: 18 Years to 70 Years
- Genders Eligible for Study: Both
- Accepts Healthy Volunteers: No Criteria
- Subject is between 18 and 70 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
You may not qualify if:
- Subjects currently prescribed Campath or Lemtrada
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
Richard Bartholomew
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 24, 2014
First Posted
May 29, 2014
Study Start
March 9, 2020
Primary Completion
March 9, 2022
Study Completion
March 9, 2022
Last Updated
March 11, 2020
Record last verified: 2020-03