Multiple SclerosisPhase 2NCT02149706
A Study of NeuroVax™, a Novel Therapeutic TCR Peptide Vaccine for SPMS of Multiple Sclerosis
A Phase 2 study testing NeuroVax and IFA Incomplete Freund's Adjuvant in people with Multiple Sclerosis, run by Immune Response BioPharma, Inc. at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- NeuroVax and IFA Incomplete Freund's Adjuvant
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Mar 2020to 9 Mar 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Show all 10Show fewer
- 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
Who cannot join
- Subjects currently prescribed Campath or Lemtrada
Trial locations and contacts
1 site in 1 country.
Richard Bartholomew contact
United States1 site
CRO
San Diego, California, 92129
Richard M Bartholomew, PhD, 858-414-4664, Richardmbartholomew@gmail.com
Richard Bartholomew, Phd
About this study
Official title: A Phase IIb Study of NeuroVax™, a Novel Therapeutic TCR Peptide Vaccine for SPMS of Multiple Sclerosis Slowing Disease Progression Via Vaccination
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.
Read the detailed description
The primary objective is to compare between treatment groups the Measures of neurologic disability EDSS scores.
- Conditions
- Multiple Sclerosis
- Being tested
- NeuroVax, IFA Incomplete Freund's Adjuvant
- Keywords
- Secondary Progress Multiple Sclerosis, SPMS, Multiple Sclerosis, NeuroVax
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeuroVaxBiological
NeuroVax consists of a Trivalent TCR Peptide Formulation in IFA
IFA Incomplete Freund's AdjuvantBiological
IFA Placebo Incomplete Freund's Adjuvant
| Study group | Role | What they receive |
|---|---|---|
| NeuroVax | Experimental | NeuroVax Receives: Biological: NeuroVax |
| IFA Incomplete Freund's Adjuvant | Placebo comparator | Incomplete Freund's Adjuvant IFA Receives: Biological: IFA Incomplete Freund's Adjuvant |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective is to compare between treatment groups the Measures of neurologic disability EDSS score
The primary objective is to compare between treatment groups the Measures of neurologic disability EDSS scores improvements
Measured: 48 Weeks
Secondary outcomes (1)
Secondary measurements objectives immunologic evaluations
Secondary measurements objectives immunologic evaluations increases in white blood cell counts \& FOXP+3 expression increases
Measured: 48 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2014 (estimated)
- Study start9 Mar 2020 (estimated)
- Primary completion9 Mar 2022 (estimated)
- Study completion9 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Immune Response BioPharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- cro
- Responsible party
- Sponsor
- Investigators
- Richard M Bartholomew, Ph.D, Study director, Immune Response BioPharma, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02149706
- Sponsor's protocol ID
- Immune Response 2020
- Status last verified
- Mar 2020
- First submitted
- 24 May 2014
- Last updated
- 11 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIb Study of NeuroVax™, a Novel Therapeutic TCR Peptide Vaccine for SPMS of Multiple Sclerosis Slowing Disease Progression Via Vaccination
- ClinicalTrials.gov ID
- NCT02149706
- Acronym / sponsor ID
- Immune Response 2020
- Conditions
- Multiple Sclerosis
- Keywords
- Secondary Progress Multiple Sclerosis, SPMS, Multiple Sclerosis, NeuroVax
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Immune Response BioPharma, Inc.Industry (pharma, biotech, devices)
- Collaborators
- cro
- Study start
- 9 Mar 2020 (estimated)
- Primary completion
- 9 Mar 2022 (estimated)
- Study completion
- 9 Mar 2022 (estimated)
- First posted
- 29 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The primary objective is to compare between treatment groups the Measures of neurologic disability EDSS scores.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NeuroVax | Experimental | Biological: NeuroVaxNeuroVax |
| IFA Incomplete Freund's Adjuvant | Placebo comparator | Biological: IFA Incomplete Freund's AdjuvantIncomplete Freund's Adjuvant IFA |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (1 listed)
- Subjects currently prescribed Campath or Lemtrada
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NeuroVaxNeuroVax consists of a Trivalent TCR Peptide Formulation in IFA | Biological | NeuroVax |
| IFA Incomplete Freund's AdjuvantIFA Placebo Incomplete Freund's Adjuvant | Biological | IFA Incomplete Freund's Adjuvant |
Primary outcome
The primary objective is to compare between treatment groups the Measures of neurologic disability EDSS score
Time frame: 48 Weeks
The primary objective is to compare between treatment groups the Measures of neurologic disability EDSS scores improvements
1 secondary outcome
Secondary measurements objectives immunologic evaluations
Time frame: 48 Weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Bartholomew contact
Richard M Bartholomew, Ph.D study director
Immune Response BioPharma, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NeuroVax and IFA Incomplete Freund's Adjuvant in people with Multiple Sclerosis, run by Immune Response BioPharma, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Richard M Bartholomew, Ph.D (1-858-414-4664, Richardmbartholomew@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary objective is to compare between treatment groups the Measures of neurologic disability EDSS score (time frame: 48 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2020.