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

NCT ID: NCT02375685

Last Updated: 2020-01-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

71 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2015-11-30

Brief Summary

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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

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Conditions

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Chronic Uveitis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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gevokizumab

Group Type EXPERIMENTAL

Gevokizumab

Intervention Type BIOLOGICAL

Interventions

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Gevokizumab

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institut de Recherches Internationales Servier

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Lions Eye Institute

Nedlands, , Australia

Site Status

Medical Competence

Vienna, , Austria

Site Status

CHU-Hôtel Dieu

Nantes, , France

Site Status

Universitätsklinikum

Tübingen, , Germany

Site Status

Interbalkan Medical Center

Thessaloniki, , Greece

Site Status

Ospedale San Raffaele

Milan, , Italy

Site Status

AIBILI

Coimbra, , Portugal

Site Status

Severance Hospital

Seoul, , South Korea

Site Status

ICOF ( Institut Clinic d'Oftalmologia )

Barcelona, , Spain

Site Status

Chang Gung Memorial Hospital-Linkou

Taoyuan District, , Taiwan

Site Status

Fattouma Bourguiba University hospital

Monastir, , Tunisia

Site Status

Istanbul University

Istanbul, , Turkey (Türkiye)

Site Status

Moorfields Eye Hospital NHS Foundation Trust

London, , United Kingdom

Site Status

Countries

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

References

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Tugal-Tutkun I, Pavesio C, De Cordoue A, Bernard-Poenaru O, Gul A. Use of Gevokizumab in Patients with Behcet's Disease Uveitis: An International, Randomized, Double-Masked, Placebo-Controlled Study and Open-Label Extension Study. Ocul Immunol Inflamm. 2018;26(7):1023-1033. doi: 10.1080/09273948.2017.1421233. Epub 2018 Jan 25.

Reference Type RESULT
PMID: 29370572 (View on PubMed)

Related Links

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Other Identifiers

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2013-004973-29

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CL3-78989-019

Identifier Type: -

Identifier Source: org_study_id

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