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The study will evaluate the efficacy and safety of gevokizumab in treating active ulcers of pyoderma gangrenosum (PG).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| gevokizumab | Experimental | Solution for subcutaneous injection (Part 1, Group B) |
|
| Placebo | Placebo Comparator | Solution for subcutaneous injection (Part 1, Group A) |
|
| gevokizumab open-label | Experimental | Solution for subcutaneous injection (Part 2, Open-label) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| gevokizumab | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of subjects at Day 126 with complete closure of the PG target ulcer confirmed 2 weeks later (at Day 140) and without the need for rescue treatment | Day 126 |
| Measure | Description | Time Frame |
|---|---|---|
| The proportions of subjects at Day 126 with a reduction in the target ulcer area of ≥ 75% or ≥ 90% from baseline. | Day 126 |
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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 |
|---|---|---|---|---|---|---|
| Oceanside | California | United States | ||||
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|
| gevokizumab open-label | Drug |
|
| Tampa |
| Florida |
| United States |
| Macon | Georgia | United States |
| St Louis | Missouri | United States |
| Henderson | Nevada | United States |
| Rochester | New York | United States |
| The Bronx | New York | United States |
| Benowa | Queensland | Australia |
| Woolloongabba | Queensland | Australia |
| Parkville | Victoria | Australia |
| Fremantle | Australia |
| St Leonards | Australia |
| Sydney | Australia |
| Westmead | Australia |
| Markham | Ontario | Canada |
| Richmond Hill | Ontario | Canada |
| ID | Term |
|---|---|
| D017511 | Pyoderma Gangrenosum |
| ID | Term |
|---|---|
| D011711 | Pyoderma |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017445 | Skin Diseases, Vascular |
| D012883 | Skin Ulcer |
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| ID | Term |
|---|---|
| C547697 | gevokizumab |
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