BHT-3009 IMMUNOTHERAPY IN RELAPSING REMITTING MULTIPLE SCLEROSIS
- Conditions
- Multiple sclerosis results from an auto-immune reaction characterized by inflammation within the nervous system. Myelin basic protein is a target of the autoimmune response and is generally regarded as the predominant autoantigen.BHT-3009 is a 3.5 kb bacterial plasmid expression vector containing the coding sequences for full length human myelin basic protein (hMBP).
- Registration Number
- EUCTR2005-001340-22-FI
- Lead Sponsor
- Bayhill Therapeutics
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 252
1. Definite diagnosis of multiple sclerosis by the McDonald criteria.
2. Screening cranial MRI demonstrating lesions consistent with MS.
3. One or more relapses within the previous year.
4. Clinically stable (no relapses) for > or = 50 days before beginning screening procedures and during the screening period.
5. EDSS 0 to 3,5 inclusive
6. Age > or = 18 years and < or = 55 years
7. Willing and able to give informed consent.
8. WBC>3,000; platelets > 100,000; hemoglobin > or = 10.0 g/dl.
9. AST, ALT, bilirubin < or = 2.0 x upper limit of normal.
10. Creatinine < or = 2.0 x upper limit of normal.
11. Negative test for HIV.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1. Primary progressive, secondary progressive or progressive relapsing MS.
2. More than 15 gadolinium-enhancing lesions on the first screening MRI.
3. 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.
4. Previous stem cell transplantation, total lymphoid radiation, or cytotoxic therapy.
5. Treatment with interferon, glatiramer acetate or other approved disease-modifying agent for > 180 days (lifetime total of all agents).
6. Treatment with an approved disease modifying agent within 180 days of beginning screening procedures.
7. Previous treatment of MS with an experimental agent including off-label use of approved drugs. (Allowed with approval of the Medical Monitor.)
8. Prior therapy with natalizumab (Tysabri).
9. Pregnant or lactating women.
10. Unwilling to use a medically acceptable form of birth control (e.g. hormonal contraception, intrauterine device, double barriers, sterilization of self or partner).
11. Clinically significant ECG abnormalities (e.g. acute ischemia or life-threatening arrhythmia).
12. Medical condition or social circumstances that would in the opinion of the investigator prevent full participation in the trial or evaluation of study endpoints.
13. Implanted pace makers, defibrillators or other metallic objects on or inside the body that limit performing MRI scans.
14. Known hypersensitivity or allergy to gadolinium.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: - Evaluate the effect of BHT-3009 on the mean four-week rate occurence of new gadolinium (Gd) enhancing MRI lesions in relapsing remitting multiple sclerosis.<br><br>;Secondary Objective: - Evaluate the safety and tolerability of intramuscular injections of BHT-3009 given for a total of one year<br>- Evaluate the effect of BHT-3009 on other cranial MRI measures<br>- Describe the effect of BHT-3009 therapy on relapse rate<br>- Describe the effect of BHT-3009 on subject disability scores;Primary end point(s): The primary endpoint is the mean four-week rate of occurrence of new Gd-enhancing lesions on the cranial MRIs performed every 4 weeks from Week 28 through Week 48 (6 MRIs).
- Secondary Outcome Measures
Name Time Method