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

Primary Purpose

Secondary Progress Multiple Sclerosis, Multiple Sclerosis

Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
NeuroVax
IFA Placebo
Sponsored by
Immune Response BioPharma, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Secondary Progress Multiple Sclerosis focused on measuring Secondary Progress Multiple Sclerosis, SPMS, Multiple Sclerosis, NeuroVax

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CRORecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

NeuroVax

IFA Placebo

Arm Description

NeuroVax

IFA Placebo

Outcomes

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

Secondary Outcome Measures

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

Full Information

First Posted
February 4, 2014
Last Updated
March 9, 2020
Sponsor
Immune Response BioPharma, Inc.
Collaborators
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1. Study Identification

Unique Protocol Identification Number
NCT02057159
Brief Title
A Study of NeuroVax™, a Therapeutic TCR Peptide Vaccine for SPMS of Multiple Sclerosis
Official Title
A Phase II Study of NeuroVax™, a Therapeutic TCR Peptide Vaccine for SPMS of Multiple Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 9, 2020 (Actual)
Primary Completion Date
March 9, 2023 (Anticipated)
Study Completion Date
March 9, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Immune Response BioPharma, Inc.
Collaborators
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4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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
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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Secondary Progress Multiple Sclerosis, Multiple Sclerosis
Keywords
Secondary Progress Multiple Sclerosis, SPMS, Multiple Sclerosis, NeuroVax

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
NeuroVax
Arm Type
Experimental
Arm Description
NeuroVax
Arm Title
IFA Placebo
Arm Type
Placebo Comparator
Arm Description
IFA Placebo
Intervention Type
Biological
Intervention Name(s)
NeuroVax
Intervention Description
TCR peptides in IFA
Intervention Type
Biological
Intervention Name(s)
IFA Placebo
Intervention Description
IFA Placebo
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Secondary MRI measurements objectives include additional MRI measurements, analyses of clinical relapses, measures of neurologic disability, immunologic evaluations, and safety.
Description
Secondary MRI measurements
Time Frame
48 Weeks
Title
Analyses of clinical relapses
Description
Analyses of clinical relapses
Time Frame
48 Weeks
Title
Measures of neurologic disability EDSS score
Description
Measures of neurologic disability EDSS score
Time Frame
48 Weeks
Title
Immunologic evaluations
Description
Immunologic evaluations
Time Frame
48 Weeks
Title
Safety Evaluation
Description
Safety Evaluation
Time Frame
48 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Richard M Bartholomew, Ph.D
Phone
1-858-414-4664
Email
Richardmbartholomew@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard M Bartholomew, Ph.D
Organizational Affiliation
Immune Response BioPharma, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
CRO
City
San Diego
State/Province
California
ZIP/Postal Code
92129
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Richard M Bartholomew, PhD
Phone
858-414-4664
Email
Richardmbartholomew@gmail.com
First Name & Middle Initial & Last Name & Degree
Richard Bartholomew, Phd

12. IPD Sharing Statement

Links:
URL
http://www.immuneresponse.net
Description
Immune Response BioPharma,Inc.

Learn more about this trial

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

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