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

A randomized, double-masked, placebo-controlled study of the efficacy of gevokizumab in the treatment of patients with Behçet's disease uveitis

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

Researchers can ask for a study protocol, patient-level and/or study-level clinical trial data including clinical study reports (CSRs).

They can ask all interventional clinical studies:

• submitted for new medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US).
• Where Servier or an affiliate are the Marketing Authorization Holders (MAH). The date of the first Marketing Authorization of the new medicine (or the new indication) in one of the EEA Member States will be considered within this scope.

After Marketing Authorisation in EEA or US if the study is used for the approval.

Researchers should register on Servier Data Portal and fill in the research proposal form. This form in four parts should be fully documented. The Research Proposal Form will not be reviewed until all mandatory fields are completed.