A 2-Year, Open-Label, Safety Extension Study of Gevokizumab in Subjects With Pyoderma Gangrenosum

• Status: Terminated
• Trial end date: 2016-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The study will evaluate the long-term safety of gevokizumab in treating active PG ulcers

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: XOMA (US) LLC

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