Safety and Efficacy Study of Gevokizumab to Treat Non-infectious Uveitis Controlled With Systemic Treatment

• Status: Terminated
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the efficacy of gevokizumab in reducing the risk of recurrent uveitic disease in subjects with non-infectious uveitis whose disease is currently controlled with systemic treatment.

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

Details

• Lead Sponsor: XOMA (US) LLC
• Collaborator: Institut de Recherches Internationales Servier

Criteria

Inclusion Criteria:

• Diagnosis of non-infectious intermediate, posterior, or pan- uveitis in at least one eye

• Controlled uveitic disease in both eyes

• Stable dose of oral corticosteroids in combination with selected stable immunosuppressive therapy

• Effective contraceptive measures

Exclusion Criteria:

• Infectious uveitis and masquerade syndromes

• Isolated anterior uveitis

• Contraindication to mydriatics

• Active tuberculosis disease

• History of allergic or anaphylactic reactions to monoclonal antibodies

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

• Pregnant or nursing women

Other protocol-defined inclusion/exclusion criteria may apply