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

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.

Study Overview

• Status: Terminated
• Conditions: Chronic Uveitis
• Intervention / Treatment: Biological: Gevokizumab

• Study Type: Interventional
• Enrollment (Actual): 71
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • Nedlands, Australia, 6009
    • Lions Eye Institute
• Austria
  • Wien, Austria, 1030
    • Medical Competence
• France
  • Nantes, France, 44000
    • CHU-Hôtel Dieu
• Germany
  • Tübingen, Germany, 72076
    • Universitätsklinikum
• Greece
  • Thessaloníki, Greece, 57 001
    • Interbalkan Medical Center
• Italy
  • Milano, Italy, 20132
    • Ospedale San Raffaele
• Korea, Republic of
  • Seoul, Korea, Republic of, 03722
    • Severance Hospital
• Portugal
  • Coimbra, Portugal, 3000-548
    • AIBILI
• Spain
  • Barcelona, Spain, 08028
    • ICOF ( Institut Clinic d'Oftalmologia )
• Taiwan
  • Taoyuan, Taiwan
    • Chang Gung Memorial Hospital-Linkou
• Tunisia
  • Monastir, Tunisia, 5000
    • Fattouma Bourguiba University Hospital
• Turkey
  • Istanbul, Turkey, 34390
    • Istanbul University
• United Kingdom
  • London, United Kingdom, EC1V 2PD
    • Moorfields Eye Hospital NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: gevokizumab	Biological: Gevokizumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Safety endpoints (adverse events, ...)	108 weeks

Collaborators and Investigators

• Sponsor: Institut de Recherches Internationales Servier

Publications and helpful links

General Publications

• 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.

Helpful Links

• U.S. FDA Resources
• Genetics Home Reference
• Results summary

Study record dates

Study Major Dates

• Study Start: August 1, 2014
• Primary Completion (Actual): November 1, 2015
• Study Completion (Actual): November 1, 2015

Study Registration Dates

• First Submitted: February 16, 2015
• First Submitted That Met QC Criteria: March 2, 2015
• First Posted (Estimate): March 3, 2015

Study Record Updates

• Last Update Posted (Actual): January 3, 2020
• Last Update Submitted That Met QC Criteria: January 2, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Uveitis; Intermediate Uveitis; Non-infectious Uveitis; Posterior Uveitis; Behçet's disease uveitis
• Additional Relevant MeSH Terms: Eye Diseases; Uveal Diseases; Uveitis
• Other Study ID Numbers: CL3-78989-019; 2013-004973-29 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes

IPD Plan Description

Researchers can ask for a study protocol, patient-level and/or study-level clinical trial data including clinical study reports (CSRs).

They can ask all interventional clinical studies:

• submitted for new medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US).
• Where Servier or an affiliate are the Marketing Authorization Holders (MAH). The date of the first Marketing Authorization of the new medicine (or the new indication) in one of the EEA Member States will be considered within this scope.

• IPD Sharing Time Frame: After Marketing Authorisation in EEA or US if the study is used for the approval.
• IPD Sharing Access Criteria: Researchers should register on Servier Data Portal and fill in the research proposal form. This form in four parts should be fully documented. The Research Proposal Form will not be reviewed until all mandatory fields are completed.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR)