Clinical trial NCT02057159: A Study of NeuroVax™, a Therapeutic TCR Peptide Vaccine for SPMS of Multiple Sclerosis
Official title: A Phase II Study of NeuroVax™, a Therapeutic TCR Peptide Vaccine for SPMS of Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Secondary Progress Multiple Sclerosis
Multiple Sclerosis
Keywords: Secondary Progress Multiple Sclerosis
SPMS
Multiple Sclerosis
NeuroVax
Lead sponsor: Immune Response BioPharma, Inc.
Sponsor class: INDUSTRY
Collaborators: name: cro
First posted: 2014-02-06
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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 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

Primary outcomes:
measure: 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
timeFrame: up to 48 weeks
Secondary outcomes:
measure: Secondary MRI measurements objectives include additional MRI measurements, analyses of clinical relapses, measures of neurologic disability, immunologic evaluations, and safety.
timeFrame: 48 Weeks
measure: Analyses of clinical relapses
timeFrame: 48 Weeks
measure: Measures of neurologic disability EDSS score
timeFrame: 48 Weeks
measure: Immunologic evaluations
timeFrame: 48 Weeks
measure: Safety Evaluation
timeFrame: 48 Weeks
Other outcomes:
Locations:
city: San Diego
country: United States
facility: CRO
state: California
Study officials:
affiliation: Immune Response BioPharma, Inc.
name: Richard M Bartholomew, Ph.D
role: STUDY_DIRECTOR
References: