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

A Safety Open-label Study of Gevokizumab in the Treatment of Patients With Chronic Non-infectious Uveitis Disease, an eXtension Study. The EYEGUARD-X Study

Status
Terminated
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02375685
Acronym
EYEGUARD-X
Enrollment
71
Registered
2015-03-03
Start date
2014-08-31
Completion date
2015-11-30
Last updated
2020-01-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Uveitis

Keywords

Uveitis, Non-infectious Uveitis, Intermediate Uveitis, Posterior Uveitis, Behçet's disease uveitis

Brief summary

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.

Interventions

BIOLOGICALGevokizumab

Sponsors

Institut de Recherches Internationales Servier
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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/

Design outcomes

Primary

MeasureTime frame
Safety endpoints (adverse events, ...)108 weeks

Countries

Australia, Austria, France, Germany, Greece, Italy, Portugal, South Korea, Spain, Taiwan, Tunisia, Turkey (Türkiye), United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026