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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified February 2014 by Immune Response BioPharma, Inc.
Sponsor:
Collaborators:
PPD
Oregon Health and Science University
Information provided by (Responsible Party):
Immune Response BioPharma, Inc.
ClinicalTrials.gov Identifier:
NCT02057159
First received: February 4, 2014
Last updated: February 7, 2014
Last verified: February 2014
  Purpose

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 Intervention Phase
Secondary Progress Multiple Sclerosis
Multiple Sclerosis
Biological: NeuroVax
Biological: IFA Placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Phase II Study of NeuroVax™, a Therapeutic TCR Peptide Vaccine for SPMS of Multiple Sclerosis

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 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Secondary MRI measurements objectives include additional MRI measurements, analyses of clinical relapses, measures of neurologic disability, immunologic evaluations, and safety. [ Time Frame: 48 Weeks ] [ Designated as safety issue: Yes ]
    Secondary MRI measurements

  • Analyses of clinical relapses [ Time Frame: 48 Weeks ] [ Designated as safety issue: Yes ]
    Analyses of clinical relapses

  • Measures of neurologic disability EDSS score [ Time Frame: 48 Weeks ] [ Designated as safety issue: Yes ]
    Measures of neurologic disability EDSS score

  • Immunologic evaluations [ Time Frame: 48 Weeks ] [ Designated as safety issue: Yes ]
    Immunologic evaluations

  • Safety [ Time Frame: 48 Weeks ] [ Designated as safety issue: Yes ]
    Safety


Estimated Enrollment: 200
Study Start Date: May 2015
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NeuroVax
NeuroVax
Biological: NeuroVax
Placebo Comparator: IFA Placebo
IFA Placebo
Biological: IFA Placebo
IFA Placebo

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 .

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
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
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: NCT02057159

Locations
United States, Oregon
Multiple Sclerosis Center Oregon Health & Science University Not yet recruiting
Portland, Oregon, United States, 97239
Contact: Dennis Bourdette, F.A.A.N. M.D.    504-494-7772      
Principal Investigator: Dennis Bourdette, F.A.A.N. M.D.         
Sponsors and Collaborators
Immune Response BioPharma, Inc.
PPD
Oregon Health and Science University
  More Information

Additional Information:
No publications provided

Responsible Party: Immune Response BioPharma, Inc.
ClinicalTrials.gov Identifier: NCT02057159     History of Changes
Other Study ID Numbers: IR902-231
Study First Received: February 4, 2014
Last Updated: February 7, 2014
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Autoimmune Diseases
Autoimmune Diseases of the Nervous System
Demyelinating Autoimmune Diseases, CNS
Demyelinating Diseases
Immune System Diseases
Nervous System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on November 25, 2014