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This study seeks to evaluate the safety, tolerability, pharmacokinetics (PK) and immunogenicity of ABT-555 in participants with relapsing forms of multiple sclerosis (RFMS).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 2 | Experimental | Participants will receive multiple doses of ABT-555 or placebo |
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| Group 3 | Experimental | Participants will receive multiple doses of ABT-555 or placebo |
|
| Group 1 | Experimental | Participants will receive multiple doses of ABT-555 or placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABT-555 | Drug | Intravenous Infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number and percentage of participants reporting adverse events | Throughout study from Day 1 to Day 176 | |
| Concentration of anti-drug antibody (ADA) titers of ABT-555 | Day 1 to Day 176 | |
| Time to Maximum observed plasma concentration (Tmax) of ABT-555 | Day 1 to Day 176 | |
| Maximum observed plasma concentration (Cmax) of ABT-555 | Day 1 to Day 176 | |
| Area under the concentration curve (AUC) of ABT-555 | Day 1 to Day 176 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants who experience relapse and disability progression | Throughout the study to Day 176 | |
| Lesion volume of new, newly enlarging T2 hyperintense lesions | Throughout study from Day 0 to Day 113 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| AbbVie Inc. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Compass Research LLC | Orlando | Florida | 32806 | United States | ||
| Rowe Neurology Institute |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| ID | Term |
|---|---|
| C000723102 | elezanumab |
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| Placebo | Other | Intravenous Infusion |
|
| Number of new, newly-enlarging T2 hyperintense lesions | Throughout study from Day 0 to Day 113 |
| Total number of new Gadolinium-enhancing T1 lesions | Throughout study from Day 0 to Day 113 |
| Lenexa |
| Kansas |
| 66214 |
| United States |
| Parexel International | Baltimore | Maryland | 21225 | United States |
| MIND | Farmington Hills | Michigan | 48334 | United States |
| Duke Univ Med Ctr | Durham | North Carolina | 27710 | United States |
| Tri-State Mountain Neurology | Johnson City | Tennessee | 37604 | United States |
| Clinical Trial Network | Houston | Texas | 77074 | United States |
| Integrated Neurology Services | Alexandria | Virginia | 22310 | United States |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |