Proof of Concept Study of Gevokizumab in the Treatment of Pyoderma Gangrenosum
- Registration Number
- NCT01882504
- Lead Sponsor
- XOMA (US) LLC
- Brief Summary
The study will evaluate the safety and biologic activity of gevokizumab in subjects in the acute inflammatory phase of pyoderma gangrenosum.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 8
Inclusion Criteria
- An established diagnosis of pyoderma gangrenosum
- Currently experiencing an inflammatory episode of 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description gevokizumab gevokizumab Solution for subcutaneous injection
- Primary Outcome Measures
Name Time Method Improvement in the Investigator's Assessment of the pyoderma gangrenosum target ulcer Day 1 through Day 84
- Secondary Outcome Measures
Name Time Method