Safety and Efficacy Study of Gevokizumab to Treat Active Non-infectious Uveitis (EYEGUARD™-A)

XOMA

Status and phase: Terminated; Phase 3

Conditions: Uveitis

Treatments: Drug: Dose 1 gevokizumab; Drug: Dose 2 gevokizumab; Drug: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01684345

2012-001610-42 (EudraCT Number)

X052130/CL3-78989-005

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy of gevokizumab in the treatment of active non-infectious intermediate, posterior, or pan- uveitis.

Enrollment: 200 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of non-infectious intermediate, posterior, or pan- uveitis in at least one eye
• Active uveitic disease in at least one eye
• Currently on one of the following stable treatment regimens for uveitis: oral corticosteroids; systemic immunosuppressive medication; a combination of oral corticosteroids with at least one systemic immunosuppressive medication
• Effective contraceptive measures

Exclusion criteria

• Infectious uveitis and masquerade syndromes
• Isolated anterior uveitis
• Contraindication to mydriatics
• 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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200 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

Dose 1 gevokizumab

Experimental group

Treatment:

Drug: Dose 1 gevokizumab

Dose 2 gevokizumab

Experimental group

Treatment:

Drug: Dose 2 gevokizumab