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

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

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 .

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

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

Study Contact

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92129
        • Recruiting
        • CRO
        • Contact:
        • Principal Investigator:
          • Richard Bartholomew, Phd

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 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NeuroVax
Biological: NeuroVax
TCR peptides in IFA
Placebo Comparator: IFA Placebo
Biological: IFA Placebo
IFA Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
up to 48 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Secondary MRI measurements objectives include additional MRI measurements, analyses of clinical relapses, measures of neurologic disability, immunologic evaluations, and safety.
Time Frame: 48 Weeks
Secondary MRI measurements
48 Weeks
Analyses of clinical relapses
Time Frame: 48 Weeks
Analyses of clinical relapses
48 Weeks
Measures of neurologic disability EDSS score
Time Frame: 48 Weeks
Measures of neurologic disability EDSS score
48 Weeks
Immunologic evaluations
Time Frame: 48 Weeks
Immunologic evaluations
48 Weeks
Safety Evaluation
Time Frame: 48 Weeks
Safety Evaluation
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 (Actual)

March 9, 2020

Primary Completion (Anticipated)

March 9, 2023

Study Completion (Anticipated)

March 9, 2023

Study Registration Dates

First Submitted

February 4, 2014

First Submitted That Met QC Criteria

February 5, 2014

First Posted (Estimate)

February 6, 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

  • IR902-231

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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