Efficacy and Safety Study of Gevokizumab to Treat Behcet's Disease Uveitis (EYEGUARD™-US)

XOMA

Status and phase: Terminated; Phase 3

Conditions: Behcet's Disease Uveitis

Treatments: Drug: Gevokizumab; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02258867

X052133

Details and patient eligibility

About

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

Enrollment: 4 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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4 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

Gevokizumab

Experimental group

Treatment:

Drug: Gevokizumab