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The purpose of this study is to determine the safety and tolerability of ELND002 in patients with relapsing forms of secondary progressive multiple sclerosis (SPMS) or relapsing-remitting multiple sclerosis (RRMS).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ELND002 | Experimental | ELND002 sc injection |
|
| Placebo | Placebo Comparator | placebo injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ELND002 | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| To determine the safety and tolerability of ELND002 including the identification of dose-limiting toxicity(ies) (DLT) and determination of the maximum tolerated dose (MTD) in patients with multiple sclerosis (MS). | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of PK and PD measures of ELND002 (including but not limited to Cmax, Tmax, T1/2, AUC) | Measurement of drug concentration, alpha 4 receptor saturation, soluble VCAM and MADCAM. | 12 weeks |
| Assessment of the cumulative number and volume of Gd-enhancing T1-weighed MRI brain lesions |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Berkeley | California | 94705 | United States | ||
| Research Site |
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|
| 12 weeks |
| Reduction in rate of clinical relapses. | 12 weeks |
| Fresno |
| California |
| 93710 |
| United States |
| Research Site | Newport Beach | California | 92663 | United States |
| Research Site | Aurora | Colorado | 80045 | United States |
| Research Site | Tampa | Florida | 33609 | United States |
| Research Site | Vero Beach | Florida | 32960 | United States |
| Research Site | Northbrook | Illinois | 60062 | United States |
| Research Site | Farmington Hills | Michigan | 48334 | United States |
| Research Site | Minneapolis | Minnesota | 55404 | United States |
| Research Site | Albuquerque | New Mexico | 87106 | United States |
| Research Site | Raleigh | North Carolina | 27607 | United States |
| Research Site | Cincinnati | Ohio | 45219 | United States |
| Research Site | Uniontown | Ohio | 44685 | United States |
| Research Site | Cordova | Tennessee | 78258 | United States |
| Research Site | Knoxville | Tennessee | 37920 | United States |
| Research Site | San Antonio | Texas | 78258 | United States |
| Research Site | Salt Lake City | Utah | 84106 | United States |
| Research Site | Calgary | Alberta | T2N 2T9 | Canada |
| Research Site | Greenfield Park | Quebec | J4V 2J2 | Canada |
| Research Site | Montreal | Quebec | H3A 2B4 | Canada |
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D020529 | Multiple Sclerosis, Relapsing-Remitting |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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