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

• Register: EUCTR
• Last refreshed on: 11 April 2016
• Main ID: EUCTR2013-004973-29-IT
• Date of registration: 01/08/2014
• Prospective Registration: Yes
• Primary sponsor: Institut de Recherches Internationales Servier
• Public title: Long-term safety of gevokizumab in the treatment of patients with chronic non-infectious uveitis, who previously well tolerated geovkizumab
• Scientific title: 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.
• Date of first enrolment: 02/10/2014
• Target sample size: 300
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-004973-29
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no Number of treatment arms in the trial: 1

Countries of recruitment

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

• Name: Clinical Studies Department
• Affiliation: Institute de Recherches Internationales Servier

• Name: Clinical Studies Department
• Affiliation: Institute de Recherches Internationales Servier

Key inclusion & exclusion criteria

Inclusion criteria:
- either completed participation to one of the following : CL3-78989-002 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
- 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:
- 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.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Eye Diseases [C11]

chronic non-infectious uveitis
MedDRA version: 17.0 Level: PT Classification code 10022557 Term: Intermediate uveitis System Organ Class: 10015919 - Eye disorders
MedDRA version: 17.0 Level: PT Classification code 10069034 Term: Tubulointerstitial nephritis and uveitis syndrome System Organ Class: 10038359 - Renal and urinary disorders
MedDRA version: 17.0 Level: LLT Classification code 10036370 Term: Posterior uveitis System Organ Class: 100000004862
MedDRA version: 17.0 Level: LLT Classification code 10071139 Term: Behcet's uveitis System Organ Class: 100000004866
MedDRA version: 17.0 Level: LLT Classification code 10042745 Term: Sympathetic uveitis System Organ Class: 10015919 - Eye disorders
MedDRA version: 17.0 Level: PT Classification code 10012692 Term: Diabetic uveitis System Organ Class: 10015919 - Eye disorders
MedDRA version: 17.0 Level: PT Classification code 10046851 Term: Uveitis System Organ Class: 10015919 - Eye disorders

Intervention(s)

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: GEVOKIZUMAB
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 60-

Primary Outcome(s)

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

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,...)

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: Not applicable

Secondary end point(s): Not Applicable

Secondary ID(s)

2013-004973-29-DE

CL3-78989-019

Source(s) of Monetary Support

Servier Research and Development Ltd

ADIR

Laboratorios Servier, S.L