Trial record 3 of 3 for: neurovax

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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 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:

NCT02057159

First received: February 4, 2014

Last updated: February 22, 2016

Last verified: February 2016

History of Changes

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 Intervention Model: Single Group Assignment Masking: Double Blind (Participant, 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:

Genetics Home Reference related topics: multiple sclerosis

MedlinePlus related topics: Multiple Sclerosis

U.S. FDA Resources

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 ]

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 ]
Secondary MRI measurements
Analyses of clinical relapses [ Time Frame: 48 Weeks ]
Analyses of clinical relapses
Measures of neurologic disability EDSS score [ Time Frame: 48 Weeks ]
Measures of neurologic disability EDSS score
Immunologic evaluations [ Time Frame: 48 Weeks ]
Immunologic evaluations
Safety [ Time Frame: 48 Weeks ]
Safety


Estimated Enrollment:	200
Study Start Date:	February 2017
Estimated Study Completion Date:	February 2019
Estimated Primary Completion Date:	February 2019 (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 (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

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

Contacts


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

Locations


United States, Oregon
Multiple Sclerosis Center Oregon Health & Science University	Not yet recruiting
Portland, Oregon, United States, 97239
Contact: Richard M Bartholomew, PhD 1-858-414-4664 Richardmbartholomew@gmail.com
Principal Investigator: Dennis Bourdette, F.A.A.N. M.D.

Sponsors and Collaborators

Immune Response BioPharma, Inc.

Oregon Health and Science University

Investigators


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

More Information

Additional Information:

Immune Response BioPharma,Inc. This link exits the ClinicalTrials.gov site

Oregon Health & Science University This link exits the ClinicalTrials.gov site


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 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

ClinicalTrials.gov processed this record on July 26, 2017

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