Secondary Progress Multiple SclerosisPhase 2/3NCT02057159
A Study of NeuroVax™, a Therapeutic TCR Peptide Vaccine for SPMS of Multiple Sclerosis
A Phase 2/3 study testing NeuroVax in people with Secondary Progress Multiple Sclerosis and 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. 200 subjects with Secondary Progressive SPMS Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Secondary Progress Multiple Sclerosis, Multiple Sclerosis
- What is being tested?
- NeuroVax
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Mar 2020to 9 Mar 2023
- Phase
- Phase 2/3
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
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 II Study of NeuroVax™, a Therapeutic TCR Peptide Vaccine for SPMS of Multiple Sclerosis
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
Read the 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 .
- Being tested
- NeuroVax, IFA Placebo
- 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
TCR peptides in IFA
IFA PlaceboBiological
IFA Placebo
| Study group | Role | What they receive |
|---|---|---|
| NeuroVax | Experimental | NeuroVax Receives: Biological: NeuroVax |
| IFA Placebo | Placebo comparator | IFA Placebo Receives: Biological: IFA Placebo |
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 cumulative number of new gadolinium enhancing (Gd+) lesions on brain MRI at up to 48 weeks in subjects with secondary progressive MS
Measured: up to 48 weeks
Secondary outcomes (5)
Secondary MRI measurements objectives include additional MRI measurements, analyses of clinical relapses, measures of neurologic disability, immunologic evaluations, and safety.
Secondary MRI measurements
Measured: 48 Weeks
Analyses of clinical relapses
Analyses of clinical relapses
Measured: 48 Weeks
Measures of neurologic disability EDSS score
Measures of neurologic disability EDSS score
Measured: 48 Weeks
Immunologic evaluations
Immunologic evaluations
Measured: 48 Weeks
Safety Evaluation
Safety Evaluation
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 posted6 Feb 2014 (estimated)
- Study start9 Mar 2020
- Primary completion9 Mar 2023 (estimated)
- Study completion9 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Secondary Progress 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 200 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
- NCT02057159
- Sponsor's protocol ID
- IR902-231
- Status last verified
- Mar 2020
- First submitted
- 4 Feb 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 II Study of NeuroVax™, a Therapeutic TCR Peptide Vaccine for SPMS of Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT02057159
- Acronym / sponsor ID
- IR902-231
- Keywords
- Secondary Progress Multiple Sclerosis, SPMS, Multiple Sclerosis, NeuroVax
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Immune Response BioPharma, Inc.Industry (pharma, biotech, devices)
- Collaborators
- cro
- Study start
- 9 Mar 2020 (actual)
- Primary completion
- 9 Mar 2023 (estimated)
- Study completion
- 9 Mar 2023 (estimated)
- First posted
- 6 Feb 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. 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 .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NeuroVax | Experimental | Biological: NeuroVaxNeuroVax |
| IFA Placebo | Placebo comparator | Biological: IFA PlaceboIFA Placebo |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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:
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| NeuroVaxTCR peptides in IFA | Biological | NeuroVax |
| IFA PlaceboIFA Placebo | Biological | IFA Placebo |
Primary outcome
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
5 secondary outcomes
Secondary MRI measurements objectives include additional MRI measurements, analyses of clinical relapses, measures of neurologic disability, immunologic evaluations, and safety.
Time frame: 48 Weeks
Analyses of clinical relapses
Time frame: 48 Weeks
Measures of neurologic disability EDSS score
Time frame: 48 Weeks
Immunologic evaluations
Time frame: 48 Weeks
Safety Evaluation
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.
Related trials for Secondary Progress Multiple Sclerosis
Not yet recruitingPhase 1/2
C-CAR168, an Autologous Anti-CD20/BCMA Chimeric Antigen Receptor T-Cell Therapy, in Participants With Progressive Multiple Sclerosis Refractory to Standard Therapy
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RecruitingObservational study
Cognitive Performance, Sleep Disturbances and Fatigue in Multiple Sclerosis
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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 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 2/3 study testing NeuroVax in people with Secondary Progress Multiple Sclerosis and 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 7 inclusion and 0 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 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). 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.