Efficacy and Safety Study of Gevokizumab to Treat Behcet's Disease Uveitis

A Randomized-Withdrawal, Double-Masked, Placebo-Controlled Study of the Efficacy and Safety of Gevokizumab in Treating Subjects With Behcet's Disease Uveitis

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02258867

Acronym

EYEGUARD™-US

Enrollment

Registered

2014-10-08

Start date

2014-11-30

Completion date

2015-11-30

Last updated

2015-12-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Behcet's Disease Uveitis

Keywords

Uveitis, Behcet's Disease Uveitis, Behcet's Disease

Brief summary

The objective of this study is to assess the efficacy and safety of gevokizumab in treating Behcet's disease uveitis (BDU).

Interventions

DRUGPlacebo

Solution for subcutaneous injection

DRUGGevokizumab

Solution for subcutaneous injection

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Have characteristics of Behcet's disease consistent with International Criteria for Behcet's disease * Have a documented history of active uveitis with or without retinal vasculitis within the past 12 months * Best corrected visual acuity (BCVA) \>= 20 ETDRS letters in both eyes at baseline * Effective contraceptive measures

Exclusion criteria

* Infectious uveitis and masquerade syndromes * End stage ocular disease * History of allergic or anaphylactic reactions to monoclonal antibodies * Active tuberculosis disease * History of recurrent infection or predisposition to infection; active ocular infection * Pregnant or nursing women Other protocol-defined inclusion/

Design outcomes

Primary

Measure	Time frame	Description
Time to first ocular exacerbation	Randomization through Day 280	Time to first ocular exacerbation is defined as the number of days from randomization to the first ocular exacerbation.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026