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

Immune Response BioPharma

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Multiple Sclerosis; Secondary Progress Multiple Sclerosis

Treatments: Biological: IFA Placebo; Biological: NeuroVax

Study type: Interventional

Funder types: Industry

Identifiers

NCT02057159

IR902-231

Details and patient eligibility

About

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

Full 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 .

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion and 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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200 participants in 2 patient groups, including a placebo group

NeuroVax

Experimental group

Description:

NeuroVax

Treatment:

Biological: NeuroVax

IFA Placebo

Placebo Comparator group

Description:

IFA Placebo

Treatment:

Biological: IFA Placebo