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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02057159
Recruitment Status : Recruiting
First Posted : February 6, 2014
Last Update Posted : March 11, 2020
Sponsor:
Collaborator:
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Information provided by (Responsible Party):
Immune Response BioPharma, Inc.

Study Description
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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

Condition or disease Intervention/treatment Phase
Secondary Progress Multiple Sclerosis Multiple Sclerosis Biological: NeuroVax Biological: IFA Placebo Phase 2 Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase II Study of NeuroVax™, a Therapeutic TCR Peptide Vaccine for SPMS of Multiple Sclerosis
Actual Study Start Date : March 9, 2020
Estimated Primary Completion Date : March 9, 2023
Estimated Study Completion Date : March 9, 2023

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Arms and Interventions
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Arm Intervention/treatment
Experimental: NeuroVax
NeuroVax
 Biological: NeuroVax
TCR peptides in IFA
Placebo Comparator: IFA Placebo
IFA Placebo
 Biological: IFA Placebo
IFA Placebo


Outcome Measures
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Primary Outcome Measures :
  1. 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 Measures :
  1. 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

  2. Analyses of clinical relapses [ Time Frame: 48 Weeks ]
    Analyses of clinical relapses

  3. Measures of neurologic disability EDSS score [ Time Frame: 48 Weeks ]
    Measures of neurologic disability EDSS score

  4. Immunologic evaluations [ Time Frame: 48 Weeks ]
    Immunologic evaluations

  5. Safety Evaluation [ Time Frame: 48 Weeks ]
    Safety Evaluation


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02057159


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

Locations
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United States, California
CRO Recruiting
San Diego, California, United States, 92129
Contact: Richard M Bartholomew, PhD    858-414-4664    Richardmbartholomew@gmail.com   
Principal Investigator: Richard Bartholomew, Phd         
Sponsors and Collaborators
Immune Response BioPharma, Inc.
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Investigators
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Study Director: Richard M Bartholomew, Ph.D Immune Response BioPharma, Inc.
More Information
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Additional Information:

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Responsible Party: Immune Response BioPharma, Inc.
ClinicalTrials.gov Identifier: NCT02057159    
Other Study ID Numbers: IR902-231
First Posted: February 6, 2014    Key Record Dates
Last Update Posted: March 11, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Immune Response BioPharma, Inc.:
Secondary Progress Multiple Sclerosis
SPMS
Multiple Sclerosis
NeuroVax
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
 Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases