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

Sponsor
Immune Response BioPharma, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT02057159
Collaborator
cro (Other)
200
1
2
36
5.6

Study Details

Study Description

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
  • 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

Study Type:
Interventional
Anticipated 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 :
Mar 9, 2020
Anticipated Primary Completion Date :
Mar 9, 2023
Anticipated Study Completion Date :
Mar 9, 2023

Arms and Interventions

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

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 [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. [48 Weeks]

    Secondary MRI measurements

  2. Analyses of clinical relapses [48 Weeks]

    Analyses of clinical relapses

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

    Measures of neurologic disability EDSS score

  4. Immunologic evaluations [48 Weeks]

    Immunologic evaluations

  5. Safety Evaluation [48 Weeks]

    Safety Evaluation

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 50 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 CRO San Diego California United States 92129

Sponsors and Collaborators

  • Immune Response BioPharma, Inc.
  • cro

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Immune Response BioPharma, Inc.
ClinicalTrials.gov Identifier:
NCT02057159
Other Study ID Numbers:
  • IR902-231
First Posted:
Feb 6, 2014
Last Update Posted:
Mar 11, 2020
Last Verified:
Mar 1, 2020
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.
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 11, 2020