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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2015-09-30

Brief Summary

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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

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Detailed Description

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

Conditions

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Behcet's Uveitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Gevokizumab

Solution for subcutaneous injection, Dose 1

Group Type EXPERIMENTAL

Gevokizumab

Intervention Type DRUG

Sterile solution administered subcutaneously

Placebo

Solution for subcutaneous injection, placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Sterile solution administered subcutaneously

Interventions

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Gevokizumab

Sterile solution administered subcutaneously

Intervention Type DRUG

Placebo

Sterile solution administered subcutaneously

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No