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

Phase 3

Terminated

• Conditions: Chronic Uveitis

• Registration Number: NCT02375685
• Lead Sponsor: Institut de Recherches Internationales Servier

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-08
• Study First Submitted: 2015-02-16
• Study First Submitted QC: 2015-03-02
• Study First Posted: 2015-03-03
• Primary Completion: 2015-11
• Study Completion: 2015-11
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-02
• Last Update Posted: 2020-01-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 71

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Safety endpoints (adverse events, ...)	108 weeks

Trial Locations

Locations (13)

Lions Eye Institute; 🇦🇺 Nedlands, Australia

Medical Competence; 🇦🇹 Wien, Austria

CHU-Hôtel Dieu; 🇫🇷 Nantes, France

Universitätsklinikum; 🇩🇪 Tübingen, Germany

Interbalkan Medical Center; 🇬🇷 Thessaloníki, Greece

Ospedale San Raffaele; 🇮🇹 Milano, Italy

Severance Hospital; 🇰🇷 Seoul, Korea, Republic of

AIBILI; 🇵🇹 Coimbra, Portugal

ICOF ( Institut Clinic d'Oftalmologia ); 🇪🇸 Barcelona, Spain

Chang Gung Memorial Hospital-Linkou; 🇨🇳 Taoyuan, Taiwan

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