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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02057159
• Date of registration: 04/02/2014
• Prospective Registration: Yes
• Primary sponsor: Immune Response BioPharma, Inc.
• Public title: A Study of NeuroVax™, a Therapeutic TCR Peptide Vaccine for SPMS of Multiple Sclerosis
• Scientific title: A Phase II Study of NeuroVax™, a Therapeutic TCR Peptide Vaccine for SPMS of Multiple Sclerosis
• Date of first enrolment: March 9, 2020
• Target sample size: 200
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT02057159
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 2/Phase 3

Countries of recruitment

United States

Contacts

• Name: Richard M Bartholomew, Ph.D
• Affiliation: Immune Response BioPharma, Inc.

• Name: Richard M Bartholomew, PhD

• Name: Richard M Bartholomew, Ph.D

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 50 Years
Gender: All

Health Condition(s) or Problem(s) studied

Secondary Progress Multiple Sclerosis

Multiple Sclerosis

Intervention(s)

Biological: NeuroVax

Biological: IFA Placebo

Primary Outcome(s)

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(s)

Analyses of clinical relapses [Time Frame: 48 Weeks]

Safety Evaluation [Time Frame: 48 Weeks]

Immunologic evaluations [Time Frame: 48 Weeks]

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

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 ID(s)

IR902-231

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

cro