Efficacy of Gevokizumab in the Treatment of Patients With Behçet's Disease Uveitis (EYEGUARD™-B) (EYEGUARD™-B)
Primary Purpose
Behcet's Uveitis
Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Gevokizumab
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Behcet's Uveitis
Eligibility Criteria
Inclusion Criteria:
- Behçet's disease diagnosis fulfilling the International Study Group Classification Criteria.
- History of Behçet's disease uveitis with ocular involvement of the posterior segment.
- Patients with a stable background treatment of oral corticosteroid and at least one immunosuppressive drug.
- Male or female, age ≥18 (or legal age of majority in the country) at selection
- For subjects with reproductive potential, a willingness to use highly effective contraceptive measures
Exclusion Criteria:
- Infectious uveitis, uveitis due to causes other than Behçet's disease.
- Monocular vision
- Presence of severe cataract or severe posterior capsular opacification.
- Contraindication to mydriasis or presence of posterior synechiae.
- Active TB disease.
- History of severe allergic or anaphylactic reactions to monoclonal antibodies
- History of malignancy within 5 years prior to Selection.
Other protocol-defined inclusion/exclusion criteria may apply
Sites / Locations
- Yonsei University Severance Hospital
- St Thomas' Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Gevokizumab
Placebo
Arm Description
Solution for subcutaneous injection, Dose 1
Solution for subcutaneous injection, placebo
Outcomes
Primary Outcome Measures
Time to first acute ocular exacerbation
number of days
Secondary Outcome Measures
Full Information
NCT ID
NCT01965145
First Posted
September 17, 2013
Last Updated
January 2, 2020
Sponsor
Institut de Recherches Internationales Servier
1. Study Identification
Unique Protocol Identification Number
NCT01965145
Brief Title
Efficacy of Gevokizumab in the Treatment of Patients With Behçet's Disease Uveitis (EYEGUARD™-B)
Acronym
EYEGUARD™-B
Official Title
A Randomized, Double-masked, Placebo-controlled Study of the Efficacy of Gevokizumab in the Treatment of Patients With Behçet's Disease Uveitis
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Terminated
Study Start Date
November 2012 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
September 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
Yes
5. Study Description
Brief Summary
The objective of this study is to demonstrate the superiority of gevokizumab as compared to placebo on top of current standard of care in reducing the risk of Behçet's disease uveitis exacerbations
Detailed Description
A randomized, double-masked, placebo-controlled study of the efficacy of gevokizumab in the treatment of patients with Behçet's disease uveitis
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Behcet's Uveitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
84 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Gevokizumab
Arm Type
Experimental
Arm Description
Solution for subcutaneous injection, Dose 1
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Solution for subcutaneous injection, placebo
Intervention Type
Drug
Intervention Name(s)
Gevokizumab
Intervention Description
Sterile solution administered subcutaneously
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Sterile solution administered subcutaneously
Primary Outcome Measure Information:
Title
Time to first acute ocular exacerbation
Description
number of days
Time Frame
up to 3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Behçet's disease diagnosis fulfilling the International Study Group Classification Criteria.
History of Behçet's disease uveitis with ocular involvement of the posterior segment.
Patients with a stable background treatment of oral corticosteroid and at least one immunosuppressive drug.
Male or female, age ≥18 (or legal age of majority in the country) at selection
For subjects with reproductive potential, a willingness to use highly effective contraceptive measures
Exclusion Criteria:
Infectious uveitis, uveitis due to causes other than Behçet's disease.
Monocular vision
Presence of severe cataract or severe posterior capsular opacification.
Contraindication to mydriasis or presence of posterior synechiae.
Active TB disease.
History of severe allergic or anaphylactic reactions to monoclonal antibodies
History of malignancy within 5 years prior to Selection.
Other protocol-defined inclusion/exclusion criteria may apply
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sung Chul LEE, Pr
Organizational Affiliation
Severance Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yonsei University Severance Hospital
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
Facility Name
St Thomas' Hospital
City
London
ZIP/Postal Code
SE1 5EZ
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://clinicaltrials.servier.com/wp-content/uploads/CL3-78989-002_synopsis_report.pdf
Description
Results summary
Learn more about this trial
Efficacy of Gevokizumab in the Treatment of Patients With Behçet's Disease Uveitis (EYEGUARD™-B)
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