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

Servier

Status and phase: Terminated; Phase 3

Conditions: Behcet's Uveitis

Treatments: Drug: Gevokizumab; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01965145

CL3-78989-002

2012-001125-27 (EudraCT Number)

U1111-1135-1411 (Other Identifier)

Details and patient eligibility

About

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

Full description

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

Enrollment: 84 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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84 participants in 2 patient groups, including a placebo group

Gevokizumab

Experimental group

Description:

Solution for subcutaneous injection, Dose 1

Treatment:

Drug: Gevokizumab

Placebo

Placebo Comparator group

Description:

Solution for subcutaneous injection, placebo

Treatment:

Drug: Placebo