Resumen

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.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

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

Criterios de exclusión

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

Intervenciones

drug

Dose 1 gevokizumab

Solution for subcutaneous injection

drug

Dose 2 gevokizumab

Solution for subcutaneous injection

drug

Placebo

Solution for subcutaneous injection

Ubicaciones

Olivos, Buenos Aires, Argentina

Rosaria, Santa Fe Province, Argentina

Buenos Aires, Argentina

Patrocinadores

PrincipalXOMA (US) LLC

ColaboradorInstitut de Recherches Internationales Servier

A Randomized, Double-masked, Placebo-controlled Study of the Safety and Efficacy of Gevokizumab in the Treatment of Subjects With Non-infectious Intermediate, Posterior, or Pan-uveitis Currently Controlled With Systemic Treatment

Resumen

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

Dose 1 gevokizumab

Dose 2 gevokizumab

Placebo

Ubicaciones

Patrocinadores