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Safety and Efficacy Study of Gevokizumab to Treat Active Non-infectious Uveitis

A Randomized, Double-masked, Placebo-controlled Study of the Safety and Efficacy of Gevokizumab in the Treatment of Active Non-infectious Intermediate, Posterior, or Pan- Uveitis

Status
Terminated
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01684345
Acronym
EYEGUARD™-A
Enrollment
200
Registered
2012-09-12
Start date
2012-08-31
Completion date
Unknown
Last updated
2016-04-08

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

Conditions

Uveitis

Keywords

Uveitis, Non-infectious Uveitis, Intermediate Uveitis, Posterior Uveitis, Panuveitis

Brief summary

The purpose of this study is to evaluate the efficacy of gevokizumab in the treatment of active non-infectious intermediate, posterior, or pan- uveitis.

Interventions

DRUGPlacebo

Solution for subcutaneous injection

DRUGDose 1 gevokizumab

Solution for subcutaneous injection

DRUGDose 2 gevokizumab

Solution for subcutaneous injection

Sponsors

Institut de Recherches Internationales Servier
CollaboratorOTHER
XOMA (US) LLC
Lead SponsorINDUSTRY

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
No

Inclusion criteria

* Diagnosis of non-infectious intermediate, posterior, or pan- uveitis in at least one eye * Active uveitic disease in at least one eye * Currently on one of the following stable treatment regimens for uveitis: oral corticosteroids; systemic immunosuppressive medication; a combination of oral corticosteroids with at least one systemic immunosuppressive medication * Effective contraceptive measures

Exclusion criteria

* Infectious uveitis and masquerade syndromes * Isolated anterior uveitis * Contraindication to mydriatics * 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

MeasureTime frameDescription
The proportion of responders at Day 56Day 56A response is defined as an improvement of the study eye without deterioration in the contralateral eye.

Countries

Argentina, Armenia, Australia, Austria, Brazil, China, France, Germany, Greece, Israel, Mexico, Poland, Portugal, Russia, South Africa, South Korea, Spain, Taiwan, Tunisia, Turkey (Türkiye), United Kingdom, United States

Outcome results

None listed

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