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

This study is not yet open for participant recruitment.
See Contacts and Locations
Verified February 2016 by Immune Response BioPharma, Inc.
Sponsor:
Collaborator:
Oregon Health and Science University
Information provided by (Responsible Party):
Immune Response BioPharma, Inc.
ClinicalTrials.gov Identifier:
NCT02149706
First received: May 24, 2014
Last updated: February 22, 2016
Last verified: February 2016
  Purpose
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.

Condition Intervention Phase
Multiple Sclerosis Biological: NeuroVax Biological: IFA Incomplete Freund's Adjuvant Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase IIb Study of NeuroVax™, a Novel Therapeutic TCR Peptide Vaccine for SPMS of Multiple Sclerosis Slowing Disease Progression Via Vaccination

Resource links provided by NLM:


Further study details as provided by Immune Response BioPharma, Inc.:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • Secondary measurements objectives immunologic evaluations [ Time Frame: 48 Weeks ]
    Secondary measurements objectives immunologic evaluations increases in white blood cell counts & FOXP+3 expression increases


Estimated Enrollment: 150
Study Start Date: March 2017
Estimated Study Completion Date: March 2019
Estimated Primary Completion Date: March 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NeuroVax
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

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

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02149706

Contacts
Contact: Richard M Bartholomew, Ph.D 1-858-414-4664 Richardmbartholomew@gmail.com

Locations
United States, Oregon
OHSU MS Center Not yet recruiting
Portland, Oregon, United States, 97239
Contact: Richard M Bartholomew, PhD    858-414-4664    Richardmbartholomew@gmail.com   
Principal Investigator: Dennis Bourdette, FAAN MD         
Sponsors and Collaborators
Immune Response BioPharma, Inc.
Oregon Health and Science University
Investigators
Principal Investigator: Dennis Bourdette, MD F.A.A.N. Oregon Health and Science University
Study Director: Richard M Bartholomew, Ph.D Immune Response BioPharma, Inc.
  More Information

Additional Information:
Responsible Party: Immune Response BioPharma, Inc.
ClinicalTrials.gov Identifier: NCT02149706     History of Changes
Other Study ID Numbers: Immune Response 2020
Study First Received: May 24, 2014
Last Updated: February 22, 2016

Keywords provided by Immune Response BioPharma, Inc.:
Secondary Progress Multiple Sclerosis
SPMS
Multiple Sclerosis
NeuroVax

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Freund's Adjuvant
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 21, 2017