Status:
COMPLETED
Proof of Concept Study of Gevokizumab in the Treatment of Pyoderma Gangrenosum
Lead Sponsor:
XOMA (US) LLC
Conditions:
Pyoderma Gangrenosum
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The study will evaluate the safety and biologic activity of gevokizumab in subjects in the acute inflammatory phase of pyoderma gangrenosum.
Eligibility Criteria
Inclusion
- An established diagnosis of pyoderma gangrenosum
- Currently experiencing an inflammatory episode of pyoderma gangrenosum
- Contraceptive measures adequate to prevent pregnancy during the study
Exclusion
- 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
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2015
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT01882504
Start Date
May 1 2013
End Date
October 1 2015
Last Update
February 3 2016
Active Locations (19)
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1
Birmingham, Alabama, United States
2
Miami, Florida, United States
3
Miami Shores, Florida, United States
4
Chicago, Illinois, United States