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

Primary Purpose

Multiple Sclerosis

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

About this trial

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

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Subjects currently prescribed Campath or Lemtrada

Sites / Locations

  • CRO

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

NeuroVax

IFA Incomplete Freund's Adjuvant

Arm Description

NeuroVax

Incomplete Freund's Adjuvant IFA

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Secondary measurements objectives immunologic evaluations
Secondary measurements objectives immunologic evaluations increases in white blood cell counts & FOXP+3 expression increases

Full Information

First Posted
May 24, 2014
Last Updated
March 9, 2020
Sponsor
Immune Response BioPharma, Inc.
Collaborators
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1. Study Identification

Unique Protocol Identification Number
NCT02149706
Brief Title
A Study of NeuroVax™, a Novel Therapeutic TCR Peptide Vaccine for SPMS of Multiple Sclerosis
Official Title
A Phase IIb Study of NeuroVax™, a Novel Therapeutic TCR Peptide Vaccine for SPMS of Multiple Sclerosis Slowing Disease Progression Via Vaccination
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 9, 2020 (Anticipated)
Primary Completion Date
March 9, 2022 (Anticipated)
Study Completion Date
March 9, 2022 (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. 150 subjects with Secondary Progressive SPMS.
Detailed Description
The primary objective is to compare between treatment groups the Measures of neurologic disability EDSS scores.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
NeuroVax
Arm Type
Experimental
Arm Description
NeuroVax
Arm Title
IFA Incomplete Freund's Adjuvant
Arm Type
Placebo Comparator
Arm Description
Incomplete Freund's Adjuvant IFA
Intervention Type
Biological
Intervention Name(s)
NeuroVax
Intervention Description
NeuroVax consists of a Trivalent TCR Peptide Formulation in IFA
Intervention Type
Biological
Intervention Name(s)
IFA Incomplete Freund's Adjuvant
Intervention Description
IFA Placebo Incomplete Freund's Adjuvant
Primary Outcome Measure Information:
Title
The primary objective is to compare between treatment groups the Measures of neurologic disability EDSS score
Description
The primary objective is to compare between treatment groups the Measures of neurologic disability EDSS scores improvements
Time Frame
48 Weeks
Secondary Outcome Measure Information:
Title
Secondary measurements objectives immunologic evaluations
Description
Secondary measurements objectives immunologic evaluations increases in white blood cell counts & FOXP+3 expression increases
Time Frame
48 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Subjects currently prescribed Campath or Lemtrada
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
First Name & Middle Initial & Last Name or Official Title & Degree
Richard Bartholomew
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
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 Novel Therapeutic TCR Peptide Vaccine for SPMS of Multiple Sclerosis

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