Safety and Efficacy Study of Gevokizumab to Treat Non-infectious Uveitis Controlled With Systemic Treatment (EYEGUARD™-C)

XOMA

Status and phase: Terminated; Phase 3

Conditions: Uveitis

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

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01747538

2012-001609-25 (EudraCT Number)

U1111-1135-1462 (Other Identifier)

X052131/CL3-78989-006

Details and patient eligibility

About

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.

Enrollment: 281 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
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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281 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