Long-term safety of gevokizumab in the treatment of patients with chronic non-infectious uveitis, who previously well tolerated geovkizumab

A safety open-label study of Gevokizumab in the treatment of patients with chronic non-infectious Uveitis disease, an eXtension study. The EYEGUARD-X study.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-004973-29-DE

Enrollment

300

Registered

2014-07-24

Start date

2014-08-13

Completion date

Unknown

Last updated

2016-01-11

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

Conditions

chronic non-infectious uveitis MedDRA version: 18.0 Level: LLT Classification code 10022557 Term: Intermediate uveitis System Organ Class: 10015919 - Eye disorders MedDRA version: 18.0 Level: PT Classification code 10069034 Term: Tubulointerstitial nephritis and uveitis syndrome System Organ Class: 10038359 - Renal and urinary disorders MedDRA version: 18.0 Level: LLT Classification code 10036370 Term: Posterior uveitis System Organ Class: 100000004862 MedDRA version: 18.0 Level: LLT Classif

Interventions

Product Name: Gevokizumab Product Code: S78989 Pharmaceutical Form: Solution for injection INN or Proposed INN: GEVOKIZUMAB CAS Number: 1129435-60-4 Current Sponsor code: S78989 Other descriptive name

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - either completed participation to one of the following : CL3-78989-002 double masked period or open label extension, or X052130/CL3-78989-005 double masked period or open label period, or X052131/CL3-78989-006 double masked period or open label period, or currently benefiting from gevokizumab compassionate use after participation in gevokizumab uveitis studies, - Able to receive the first injection of gevokizumab within 6 weeks after the last study drug administration. In some exceptional cases when the time period since last study drug administration in previous studies is more than 6 weeks, patients should be considered in the investigator's opinion in stable ophtalmological conditions at the inclusion visit. - 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 270 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30

Exclusion criteria

Exclusion criteria: - Meeting criteria for discontinuation of any of gevokizumab uveitis previous study. - Infectious uveitis and masquerade syndrome. - History of severe allergic or anaphylactic reaction to study drug administration during previous study or to gevokizumab or any of its excipient. - Currently active Infectious disease.

Design outcomes

Primary

Measure	Time frame
Main Objective: The objective of this study is to evaluate long-term safety of gevokizumab in patient with chronic non-infectious uveitis who previously well tolerated the study drug and may benefit from longterm treatment with gevokizumab;Secondary Objective: Not applicable;Primary end point(s): Safety endpoints (adverse events assessment, vital signs, laboratory parameters, ophtalmological assessments,...);Timepoint(s) of evaluation of this end point: -Adverse events and vital signs : From inclusion until the end of the study -laboratory parameters and ophtalmologic assessment : each 16 weeks from inclusion until the end of the study	—

Measure

Time frame

Main Objective: The objective of this study is to evaluate long-term safety of gevokizumab in patient with chronic non-infectious uveitis who previously well tolerated the study drug and may benefit from longterm treatment with gevokizumab;Secondary Objective: Not applicable;Primary end point(s): Safety endpoints (adverse events assessment, vital signs, laboratory parameters, ophtalmological assessments,...);Timepoint(s) of evaluation of this end point: -Adverse events and vital signs : From inclusion until the end of the study -laboratory parameters and ophtalmologic assessment : each 16 weeks from inclusion until the end of the study

—

Secondary

Measure	Time frame
Timepoint(s) of evaluation of this end point: Not applicable;Secondary end point(s): Not Applicable	—

Countries

Argentina, Armenia, Australia, Austria, Brazil, Canada, China, European Union, France, Germany, Greece, Hong Kong, Israel, Italy, Korea, Republic of, Mexico, Poland, Portugal, Russian Federation, South Africa, Spain, Taiwan, Tunisia, Turkey, United Kingdom

Contacts

Public ContactClinical Studies Department

Institut de Recherches Internationales Servier

clinicaltrials@servier.com+33155 72 43 66

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026