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

Primary Purpose

Chronic Uveitis

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Gevokizumab
Sponsored by
Institut de Recherches Internationales Servier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Uveitis focused on measuring Uveitis, Non-infectious Uveitis, Intermediate Uveitis, Posterior Uveitis, Behçet's disease uveitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Lions Eye Institute
  • Medical Competence
  • CHU-Hôtel Dieu
  • Universitätsklinikum
  • Interbalkan Medical Center
  • Ospedale San Raffaele
  • Severance Hospital
  • AIBILI
  • ICOF ( Institut Clinic d'Oftalmologia )
  • Chang Gung Memorial Hospital-Linkou
  • Fattouma Bourguiba University hospital
  • Istanbul University
  • Moorfields Eye Hospital NHS Foundation Trust

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

gevokizumab

Arm Description

Outcomes

Primary Outcome Measures

Safety endpoints (adverse events, ...)

Secondary Outcome Measures

Full Information

First Posted
February 16, 2015
Last Updated
January 2, 2020
Sponsor
Institut de Recherches Internationales Servier
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1. Study Identification

Unique Protocol Identification Number
NCT02375685
Brief Title
Long-term Safety of Gevokizumab in the Treatment of Patients With Chronic Non-infectious Uveitis (EYEGUARD-X)
Acronym
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

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Terminated
Study Start Date
August 2014 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
November 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut de Recherches Internationales Servier

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Uveitis
Keywords
Uveitis, Non-infectious Uveitis, Intermediate Uveitis, Posterior Uveitis, Behçet's disease uveitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
71 (Actual)

8. Arms, Groups, and Interventions

Arm Title
gevokizumab
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
Gevokizumab
Primary Outcome Measure Information:
Title
Safety endpoints (adverse events, ...)
Time Frame
108 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Lions Eye Institute
City
Nedlands
ZIP/Postal Code
6009
Country
Australia
Facility Name
Medical Competence
City
Wien
ZIP/Postal Code
1030
Country
Austria
Facility Name
CHU-Hôtel Dieu
City
Nantes
ZIP/Postal Code
44000
Country
France
Facility Name
Universitätsklinikum
City
Tübingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
Interbalkan Medical Center
City
Thessaloníki
ZIP/Postal Code
57 001
Country
Greece
Facility Name
Ospedale San Raffaele
City
Milano
ZIP/Postal Code
20132
Country
Italy
Facility Name
Severance Hospital
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
AIBILI
City
Coimbra
ZIP/Postal Code
3000-548
Country
Portugal
Facility Name
ICOF ( Institut Clinic d'Oftalmologia )
City
Barcelona
ZIP/Postal Code
08028
Country
Spain
Facility Name
Chang Gung Memorial Hospital-Linkou
City
Taoyuan
Country
Taiwan
Facility Name
Fattouma Bourguiba University hospital
City
Monastir
ZIP/Postal Code
5000
Country
Tunisia
Facility Name
Istanbul University
City
Istanbul
ZIP/Postal Code
34390
Country
Turkey
Facility Name
Moorfields Eye Hospital NHS Foundation Trust
City
London
ZIP/Postal Code
EC1V 2PD
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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 URL
http://clinicaltrials.servier.com
Citations:
PubMed Identifier
29370572
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.
Results Reference
result
Links:
URL
http://ghr.nlm.nih.gov/condition/behcet-disease
Description
Genetics Home Reference
URL
http://clinicaltrials.gov/ct2/info/fdalinks
Description
U.S. FDA Resources
URL
http://clinicaltrials.servier.com/wp-content/uploads/CL3-78989-019_synopsis_report.pdf
Description
Results summary

Learn more about this trial

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

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