Efficacy and Safety Study of Gevokizumab to Treat Behcet's Disease Uveitis

• Status: Terminated
• Trial end date: 2015-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The objective of this study is to assess the efficacy and safety of gevokizumab in treating Behcet's disease uveitis (BDU).

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

Details

• Lead Sponsor: XOMA (US) LLC

Criteria

Inclusion Criteria:

• Have characteristics of Behcet's disease consistent with International Criteria for Behcet's disease

• Have a documented history of active uveitis with or without retinal vasculitis within the past 12 months

• Best corrected visual acuity (BCVA) >= 20 ETDRS letters in both eyes at baseline

• Effective contraceptive measures

Exclusion Criteria:

• Infectious uveitis and masquerade syndromes

• End stage ocular disease

• History of allergic or anaphylactic reactions to monoclonal antibodies

• Active tuberculosis disease

• History of recurrent infection or predisposition to infection; active ocular infection

• Pregnant or nursing women

Other protocol-defined inclusion/exclusion criteria may apply