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The purpose of this study is to determine whether gevokizumab is effective in the treatment of moderate to severe acne vulgaris.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| low dose gevokizumab | Experimental |
| |
| high dose gevokizumab | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Sterile solution administered subcutaneously on Day 0, Day 28, and Day 56 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The mean absolute change from baseline in inflammatory facial lesion count at Day 84 | Baseline and Day 84 |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of subjects with a successful treatment outcome at Day 84 | Successful treatment outcome is defined as an improvement of >= 2 grades from the baseline grade on the dichotomized facial Investigator's Global Assessment scale. | Baseline and Day 84 |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hot Springs | Arkansas | United States | ||||
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| gevokizumab |
| Drug |
Sterile solution administered subcutaneously on Day 0, Day 28, and Day 56 |
|
| gevokizumab | Drug | Sterile solution administered subcutaneously on Day 0, Day 28, and Day 56 |
|
| Riverside |
| California |
| United States |
| San Diego | California | United States |
| Denver | Colorado | United States |
| New Haven | Connecticut | United States |
| Bay City | Michigan | United States |
| Fridley | Minnesota | United States |
| Las Vegas | Nevada | United States |
| Albuquerque | New Mexico | United States |
| Charlotte | North Carolina | United States |
| High Point | North Carolina | United States |
| Raleigh | North Carolina | United States |
| South Euclid | Ohio | United States |
| Portland | Oregon | United States |
| Arlington | Texas | United States |
| Austin | Texas | United States |
| Houston | Texas | United States |
| Salt Lake City | Utah | United States |
| Richmond | Virginia | United States |
| ID | Term |
|---|---|
| D000152 | Acne Vulgaris |
| ID | Term |
|---|---|
| D017486 | Acneiform Eruptions |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012625 | Sebaceous Gland Diseases |
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| ID | Term |
|---|---|
| C547697 | gevokizumab |
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