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

Immune Response BioPharma

Status and phase: Unknown; Phase 2

Conditions: Multiple Sclerosis

Treatments: Biological: NeuroVax; Biological: IFA Incomplete Freund's Adjuvant

Study type: Interventional

Funder types: Industry

Identifiers

NCT02149706

Immune Response 2020

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. 150 subjects with Secondary Progressive SPMS.

Full description

The primary objective is to compare between treatment groups the Measures of neurologic disability EDSS scores.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Genders Eligible for Study: Both
• Accepts Healthy Volunteers: No Criteria
• Subject is between 18 and 70 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

Exclusion criteria

• Subjects currently prescribed Campath or Lemtrada

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

150 participants in 2 patient groups, including a placebo group

NeuroVax

Experimental group

Description:

NeuroVax

Treatment:

Biological: NeuroVax

IFA Incomplete Freund's Adjuvant

Placebo Comparator group

Description:

Incomplete Freund's Adjuvant IFA

Treatment:

Biological: IFA Incomplete Freund's Adjuvant