Clinical trial NCT02375685: Long-term Safety of Gevokizumab in the Treatment of Patients With Chronic Non-infectious Uveitis (EYEGUARD-X)
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Chronic Uveitis
Keywords: Uveitis
Non-infectious Uveitis
Intermediate Uveitis
Posterior Uveitis
Behçet's disease uveitis
Lead sponsor: Servier
Sponsor class: INDUSTRY
First posted: 2015-03-03
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Safety endpoints (adverse events, ...)
timeFrame: 108 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Nedlands
country: Australia
facility: Lions Eye Institute
city: Wien
country: Austria
facility: Medical Competence
city: Nantes
country: France
facility: CHU-Hôtel Dieu
city: Tübingen
country: Germany
facility: Universitätsklinikum
city: Thessaloníki
country: Greece
facility: Interbalkan Medical Center
city: Milano
country: Italy
facility: Ospedale San Raffaele
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
city: Coimbra
country: Portugal
facility: AIBILI
city: Barcelona
country: Spain
facility: ICOF ( Institut Clinic d'Oftalmologia )
city: Taoyuan
country: Taiwan
facility: Chang Gung Memorial Hospital-Linkou
city: Monastir
country: Tunisia
facility: Fattouma Bourguiba University hospital
city: Istanbul
country: Turkey
facility: Istanbul University
city: London
country: United Kingdom
facility: Moorfields Eye Hospital NHS Foundation Trust
Study officials:
References:
citation: 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.