A 2-Year, Open-Label, Safety Extension Study of Gevokizumab in Subjects With Pyoderma Gangrenosum
- Registration Number
- NCT02318914
- Lead Sponsor
- XOMA (US) LLC
- Brief Summary
The study will evaluate the long-term safety of gevokizumab in treating active PG ulcers
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 15
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
Read More
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
Read More
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 Evaluation of treatment-emergent adverse events; Up to 2 years Changes from baseline vital signs, physical examination results, and laboratory test results Up to 2 years Changes from baseline concomitant medications use Up to 2 years
- Secondary Outcome Measures
Name Time Method