Brief Summary
The study will evaluate the long-term safety of gevokizumab in treating active PG ulcers
Brief Title
A 2-Year, Open-Label, Safety Extension Study of Gevokizumab in Subjects With Pyoderma Gangrenosum
Completion Date
Completion Date Type
Actual
Conditions
Pyoderma Gangrenosum
Eligibility Criteria
Inclusion Criteria:
* Individuals who participated in a previous study of gevokizumab in PG
* A clinical diagnosis of classic pyoderma gangrenosum
* Contraceptive measures adequate to prevent pregnancy during the study
Exclusion Criteria:
* Clinical evidence of acutely infected pyoderma gangrenosum
* History of allergic or anaphylactic reactions to monoclonal antibodies
* History of recurrent or chronic systemic infections
* Female subjects who are pregnant, planning to become pregnant, have recently delivered, or are breast-feeding
Other protocol-defined inclusion/exclusion criteria may apply
* Individuals who participated in a previous study of gevokizumab in PG
* A clinical diagnosis of classic pyoderma gangrenosum
* Contraceptive measures adequate to prevent pregnancy during the study
Exclusion Criteria:
* Clinical evidence of acutely infected pyoderma gangrenosum
* History of allergic or anaphylactic reactions to monoclonal antibodies
* History of recurrent or chronic systemic infections
* Female subjects who are pregnant, planning to become pregnant, have recently delivered, or are breast-feeding
Other protocol-defined inclusion/exclusion criteria may apply
Inclusion Criteria
Inclusion Criteria:
* Individuals who participated in a previous study of gevokizumab in PG
* A clinical diagnosis of classic pyoderma gangrenosum
* Contraceptive measures adequate to prevent pregnancy during the study
inclusion/
* Individuals who participated in a previous study of gevokizumab in PG
* A clinical diagnosis of classic pyoderma gangrenosum
* Contraceptive measures adequate to prevent pregnancy during the study
inclusion/
Gender
All
Gender Based
false
Keywords
Pyoderma Gangrenosum
Classic Pyoderma Gangrenosum
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Estimated
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT02318914
Org Class
Industry
Org Full Name
XOMA (US) LLC
Org Study Id
X052171
Overall Status
Terminated
Phases
Phase 3
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
A 2-Year, Open-Label, Safety Extension Study of Gevokizumab in Patients With Pyoderma Gangrenosum
Primary Outcomes
Outcome Measure
Evaluation of treatment-emergent adverse events;
Outcome Time Frame
Up to 2 years
Outcome Measure
Changes from baseline vital signs, physical examination results, and laboratory test results
Outcome Time Frame
Up to 2 years
Outcome Measure
Changes from baseline concomitant medications use
Outcome Time Frame
Up to 2 years
Start Date
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Holly Kanavy
Investigator Email
HKanavy@montefiore.org
Investigator Phone
866-633-8255 / 718-230-2997 / 510-996-0741