Efficacy of Gevokizumab in the Treatment of Patients With Behçet's Disease Uveitis (EYEGUARD™-B)

Behcet's Uveitis Clinical Trial

— 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01965145
• Other study ID #: CL3-78989-002
• Secondary ID: 2012-001125-27U1
• Status: Terminated
• Phase: Phase 3
• Start date: November 2012
• Est. completion date: September 2015

Study information

• Verified date: January 2020
• Source: Servier
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

A randomized, double-masked, placebo-controlled study of the efficacy of gevokizumab in the treatment of patients with Behçet's disease uveitis

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 84
• Est. completion date: September 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Behcet Syndrome
• Behcet's Uveitis
• Uveitis

Intervention

Drug:
• Gevokizumab
Sterile solution administered subcutaneously
• Placebo
Sterile solution administered subcutaneously

Locations

Country	Name	City	State
Korea, Republic of	Yonsei University Severance Hospital	Seoul
United Kingdom	St Thomas' Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
Institut de Recherches Internationales Servier

Countries where clinical trial is conducted

Korea, Republic of,  United Kingdom, 

References & Publications (1)

Tugal-Tutkun I, Pavesio C, De Cordoue A, Bernard-Poenaru O, Gül A. Use of Gevokizumab in Patients with Behçet's Disease Uveitis: An International, Randomized, Double-Masked, Placebo-Controlled Study and Open-Label Extension Study. Ocul Immunol Inflamm. 20 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to first acute ocular exacerbation	number of days	up to 3 years

External Links

•   Results summary