Relapsing Remitting Multiple SclerosisPhase 2NCT00382629
BHT-3009 Immunotherapy in Relapsing Remitting Multiple Sclerosis
A Phase 2 study testing BHT-3009 0.5 mg and BHT-3009 1.5 mg in people with Relapsing Remitting Multiple Sclerosis, run by Bayhill Therapeutics.
Trial summary
The purpose of this study is to determine if BHT-3009 decreases inflammation (measured by gadolinium enhancing MRI lesions) in the brains of people with relapsing remitting multiple sclerosis. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Relapsing Remitting Multiple Sclerosis
- What is being tested?
- BHT-3009 0.5 mg and BHT-3009 1.5 mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 252 participants
- Where
- No sites listed yet
- Study dates
- Feb 2006to Jun 2007
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Definite diagnosis of multiple sclerosis by the McDonald criteria.
- Screening cranial MRI demonstrating lesions consistent with MS.
- One or more relapses within the previous year.
- Clinically stable (no relapses) for > 50 days before beginning screening procedures and during the screening period.
- EDSS 0 to 3.5 inclusive.
- Age > 17 years and < 56 years.
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- Willing and able to give informed consent.
- WBC >3,000; platelets >100,000; hemoglobin > 10.0 g/dl.
- AST, ALT, bilirubin < 2.0 x upper limit of normal.
- Creatinine < 2.0 x upper limit of normal.
- Negative test for HIV.
Who cannot join
- Primary progressive, secondary progressive or progressive relapsing MS.
- More than 5 gadolinium-enhancing lesions on the first screening MRI.
- High-dose corticosteroids (e.g. > 500 mg methylprednisolone or equivalent per day for 3 or more days) within 50 days prior to beginning screening procedures.
- Previous stem cell transplantation, total lymphoid radiation, or cytotoxic therapy.
- Treatment with interferon, glatiramer acetate or other approved disease-modifying agent for > 180 days (lifetime total of all agents).
- Treatment with an approved disease modifying agent within 180 days of beginning screening procedures.
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- Previous treatment of MS with an experimental agent including off-label use of approved drugs. (Allowed with approval of the Medical Monitor.)
- Prior therapy with natalizumab (Tysabri).
- Pregnant or lactating women.
- Unwilling to use a medically acceptable form of birth control (e.g. hormonal contraception, intrauterine device, double barriers, sterilization of self or partner).
- Clinically significant ECG abnormalities (e.g. acute ischemia or life-threatening arrhythmia).
- Medical condition or social circumstances that would in the opinion of the investigator prevent full participation in the trial or evaluation of study endpoints.
- Implanted pace makers, defibrillators or other metallic objects on or inside the body that limit performing MRI scans.
- Known hypersensitivity or allergy to gadolinium.
About this study
The purpose of this study is to determine if BHT-3009 decreases inflammation (measured by gadolinium enhancing MRI lesions) in the brains of people with relapsing remitting multiple sclerosis.
Read the detailed description
People with multiple sclerosis are thought to have abnormal immunity. Usually the body's immune system attacks only foreign substances, but people with MS have abnormal immunity, where the immune system attacks normal proteins, one of which is a protein found in the brain called MBP (myelin basic protein). This abnormal immunity causes inflammation in the brain resulting in nerve damage. BHT-3009 is a drug that is designed to decrease this abnormal immunity to MBP. BHT-3009 is a DNA plasmid that contains the gene for MBP. Plasmids are circular pieces of DNA that are being tested in clinical trials for their ability to alter patients' immune systems. Two different doses of BHT-3009 will be tested to determine if there are any differences in their safety or effects on inflammation.
Treatment in this study is 3 doses every two weeks for 6 weeks, followed by a dose every 4 weeks for a total of 13 doses in 44 weeks.
- Conditions
- Relapsing Remitting Multiple Sclerosis
- Being tested
- BHT-3009 0.5 mg, BHT-3009 1.5 mg, Placebo
- Keywords
- Multiple sclerosis, MS, Bayhill, BHT-3009, immunotherapy
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BHT-3009 0.5 mgDrug
BHT-3009 1.5 mgDrug
PlaceboDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the effect of BHT-3009 on the mean four-week rate of occurrence of new gadolinium (Gd) enhancing MRI lesions in relapsing remitting MS.
Secondary outcomes (4)
Evaluate the safety and tolerability of intramuscular injections of BHT-3009 given for a total of one year.
Evaluate the effect of BHT-3009 on other cranial MRI measures.
Describe the effect of BHT-3009 therapy on relapse rate.
Describe the effect of BHT-3009 on subject disability scores.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2006 (estimated)
- Study startFeb 2006
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsing Remitting 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
- Enrolment
- 252 participants
Sponsor and investigators
- Lead sponsor
- Bayhill Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Frank Valone, MD, Study director, Bayhill Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00382629
- Sponsor's protocol ID
- BHT-3009-03
- Status last verified
- Feb 2008
- First submitted
- 27 Sep 2006
- Last updated
- 11 Feb 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BHT-3009 Immunotherapy in Relapsing Remitting Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT00382629
- Acronym / sponsor ID
- BHT-3009-03
- Conditions
- Relapsing Remitting Multiple Sclerosis
- Keywords
- Multiple sclerosis, MS, Bayhill, BHT-3009, immunotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 252 participants
- Lead sponsor
- Bayhill TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Feb 2006
- Study completion
- Jun 2007
- First posted
- 29 Sep 2006 (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.
The purpose of this study is to determine if BHT-3009 decreases inflammation (measured by gadolinium enhancing MRI lesions) in the brains of people with relapsing remitting multiple sclerosis.
Detailed description
People with multiple sclerosis are thought to have abnormal immunity. Usually the body's immune system attacks only foreign substances, but people with MS have abnormal immunity, where the immune system attacks normal proteins, one of which is a protein found in the brain called MBP (myelin basic protein). This abnormal immunity causes inflammation in the brain resulting in nerve damage. BHT-3009 is a drug that is designed to decrease this abnormal immunity to MBP. BHT-3009 is a DNA plasmid that contains the gene for MBP. Plasmids are circular pieces of DNA that are being tested in clinical trials for their ability to alter patients' immune systems. Two different doses of BHT-3009 will be tested to determine if there are any differences in their safety or effects on inflammation.
Treatment in this study is 3 doses every two weeks for 6 weeks, followed by a dose every 4 weeks for a total of 13 doses in 44 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Definite diagnosis of multiple sclerosis by the McDonald criteria.
- Screening cranial MRI demonstrating lesions consistent with MS.
- One or more relapses within the previous year.
- Clinically stable (no relapses) for > 50 days before beginning screening procedures and during the screening period.
- EDSS 0 to 3.5 inclusive.
Key exclusion criteria (14 listed)
- Primary progressive, secondary progressive or progressive relapsing MS.
- More than 5 gadolinium-enhancing lesions on the first screening MRI.
- High-dose corticosteroids (e.g. > 500 mg methylprednisolone or equivalent per day for 3 or more days) within 50 days prior to beginning screening procedures.
- Previous stem cell transplantation, total lymphoid radiation, or cytotoxic therapy.
- Treatment with interferon, glatiramer acetate or other approved disease-modifying agent for > 180 days (lifetime total of all agents).
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 |
|---|---|---|
| BHT-3009 0.5 mg | Drug | – |
| BHT-3009 1.5 mg | Drug | – |
| Placebo | Drug | – |
Primary outcome
Evaluate the effect of BHT-3009 on the mean four-week rate of occurrence of new gadolinium (Gd) enhancing MRI lesions in relapsing remitting MS.
4 secondary outcomes
Evaluate the safety and tolerability of intramuscular injections of BHT-3009 given for a total of one year.
Evaluate the effect of BHT-3009 on other cranial MRI measures.
Describe the effect of BHT-3009 therapy on relapse rate.
Describe the effect of BHT-3009 on subject disability scores.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2008.
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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.
Frank Valone, MD study director
Bayhill Therapeutics
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BHT-3009 0.5 mg and BHT-3009 1.5 mg in people with Relapsing Remitting Multiple Sclerosis, run by Bayhill Therapeutics.
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 11 inclusion and 14 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: finished, as of the sponsor's last update on 11 Feb 2008. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the effect of BHT-3009 on the mean four-week rate of occurrence of new gadolinium (Gd) enhancing MRI lesions in relapsing remitting MS.. 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 Feb 2008.