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

March 9, 2020 updated by: Immune Response BioPharma, Inc.

A Phase IIb Study of NeuroVax™, a Novel Therapeutic TCR Peptide Vaccine for SPMS of Multiple Sclerosis Slowing Disease Progression Via Vaccination

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The primary objective is to compare between treatment groups the Measures of neurologic disability EDSS scores.

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92129
        • CRO

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NeuroVax
Biological: NeuroVax
NeuroVax consists of a Trivalent TCR Peptide Formulation in IFA
Placebo Comparator: IFA Incomplete Freund's Adjuvant
Incomplete Freund's Adjuvant IFA
Biological: IFA Incomplete Freund's Adjuvant
IFA Placebo Incomplete Freund's Adjuvant

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The primary objective is to compare between treatment groups the Measures of neurologic disability EDSS score
Time Frame: 48 Weeks
The primary objective is to compare between treatment groups the Measures of neurologic disability EDSS scores improvements
48 Weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Secondary measurements objectives immunologic evaluations
Time Frame: 48 Weeks
Secondary measurements objectives immunologic evaluations increases in white blood cell counts & FOXP+3 expression increases
48 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Immune Response BioPharma, Inc.

Collaborators

cro

Investigators

  • Study Director: Richard M Bartholomew, Ph.D, Immune Response BioPharma, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 9, 2020

Primary Completion (Anticipated)

March 9, 2022

Study Completion (Anticipated)

March 9, 2022

Study Registration Dates

First Submitted

May 24, 2014

First Submitted That Met QC Criteria

May 28, 2014

First Posted (Estimate)

May 29, 2014

Study Record Updates

Last Update Posted (Actual)

March 11, 2020

Last Update Submitted That Met QC Criteria

March 9, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Immune Response 2020

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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