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Safety and Efficacy Study of Gevokizumab to Treat Non-infectious Uveitis Controlled With Systemic Treatment

A Randomized, Double-masked, Placebo-controlled Study of the Safety and Efficacy of Gevokizumab in the Treatment of Subjects With Non-infectious Intermediate, Posterior, or Pan-uveitis Currently Controlled With Systemic Treatment

Status
Terminated
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01747538
Acronym
EYEGUARD™-C
Enrollment
281
Registered
2012-12-11
Start date
2012-10-31
Completion date
Unknown
Last updated
2016-07-12

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 reducing the risk of recurrent uveitic disease in subjects with non-infectious uveitis whose disease is currently controlled with systemic treatment.

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 * Controlled uveitic disease in both eyes * Stable dose of oral corticosteroids in combination with selected stable immunosuppressive therapy * Effective contraceptive measures

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Proportion of subjects with an occurrence of uveitic disease through Day 168Day 0 through Day 168

Secondary

MeasureTime frame
Time to first occurrence of uveitic diseaseDay 0 through Day 168

Countries

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

Outcome results

None listed

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