Long-term Safety of Gevokizumab in the Treatment of Patients With Chronic Non-infectious Uveitis (EYEGUARD-X)

Servier

Status and phase

Terminated

Phase 3

Conditions

Chronic Uveitis

Treatments

Biological: Gevokizumab

Study type

Interventional

Funder types

Other

Identifiers

NCT02375685

2013-004973-29 (EudraCT Number)

CL3-78989-019

Details and patient eligibility

About

The objective of this study is to evaluate long-term safety of gevokizumab in patient with chronic non-infectious uveitis who previously well tolerated the study drug and may benefit from longterm treatment with gevokizumab.

Enrollment

71 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

either completed participation to one of the following: CL3-78989-002 open-label extension, or X052130/CL3-78989-005 double-masked period or open-label period, or X052131/CL3-78989-006 double-masked period or open-label period, or currently benefiting from gevokizumab compassionate use after participation in gevokizumab uveitis studies
Male or female, age ≥18 (or legal age of majority in the country) at selection.
For subject with reproductive potential, a willingness to use highly effective contraceptive measures

Exclusion criteria

Meeting criteria for discontinuation of any of gevokizumab uveitis previous study.
Infectious uveitis and masquerade syndrome
History of severe allergic or anaphylactic reaction to study drug administration during previous study or to gevokizumab or any of its excipient.
Currently active infectious disease.

Other protocol-defined inclusion/exclusion criteria may apply