Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BHT-3009 0.5 mg | Drug | |||
| BHT-3009 1.5 mg | Drug | |||
| Placebo | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | ||
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Frank Valone, MD | Bayhill Therapeutics | Study Director |
Not provided
Not provided
| Label | URL |
|---|---|
| Bayhill website | View source |
Not provided
Not provided
| ID | Term |
|---|---|
| D020529 | Multiple Sclerosis, Relapsing-Remitting |
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C544595 | BHT 3009 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Describe the effect of BHT-3009 therapy on relapse rate. |
| Describe the effect of BHT-3009 on subject disability scores. |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |