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).
Conditions
Interventions
Product Name: BHT-3009
Product Code: BHT-3009
Pharmaceutical Form: Solution for injection
Current Sponsor code: BHT-3009
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration num
Sponsors
Bayhill Therapeutics
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 3,000; platelets > 100,000; hemoglobin > or = 10.0 g/dl. 9. AST, ALT, bilirubin =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Primary progressive, secondary progressive or progressive relapsing MS. 2. More than 5 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. ;Secondary Objective: - 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 ;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). Sub-study : - Serious adverse events | — |
Countries
Czech Republic, Finland, United Kingdom
Outcome results
None listed