Efficacy of Gevokizumab in the Treatment of Patients With Behçet's Disease Uveitis (EYEGUARD™-B)

• Status: Terminated
• Trial end date: 2015-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The objective of this study is to demonstrate the superiority of gevokizumab as compared to placebo on top of current standard of care in reducing the risk of Behçet's disease uveitis exacerbations

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

Details

• Lead Sponsor: Institut de Recherches Internationales Servier; Servier
• Treatments: Pharmaceutical Solutions

Criteria

Inclusion Criteria:

• Behçet's disease diagnosis fulfilling the International Study Group Classification Criteria.

• History of Behçet's disease uveitis with ocular involvement of the posterior segment.

• Patients with a stable background treatment of oral corticosteroid and at least one immunosuppressive drug.

• Male or female, age ≥18 (or legal age of majority in the country) at selection

• For subjects with reproductive potential, a willingness to use highly effective contraceptive measures

Exclusion Criteria:

• Infectious uveitis, uveitis due to causes other than Behçet's disease.

• Monocular vision

• Presence of severe cataract or severe posterior capsular opacification.

• Contraindication to mydriasis or presence of posterior synechiae.

• Active TB disease.

• History of severe allergic or anaphylactic reactions to monoclonal antibodies

• History of malignancy within 5 years prior to Selection.

Other protocol-defined inclusion/exclusion criteria may apply