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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: EUCTR
Last refreshed on: 1 February 2016
Main ID:  EUCTR2012-001609-25-PL
Date of registration: 01/07/2014
Prospective Registration: Yes
Primary sponsor: XOMA (US) LLC
Public title: Efficacy and safety of gevokizumab in the treatment of patients with active non-infectious uveitis currently controlled with systemic treatment
Scientific title: 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. The EYEGUARD™-C study. - The EYEGUARD™-C study
Date of first enrolment: 22/09/2014
Target sample size: 300
Recruitment status: Not Recruiting
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-001609-25
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: yes Other trial design description: Open label treatment schedule for patients successfully rescued during the study If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 3  
Phase: 
Countries of recruitment
Argentina Australia Brazil China France Germany Greece Hong Kong
Italy Korea, Republic of Mexico Poland Portugal Russian Federation Spain Taiwan
Tunisia Turkey United Kingdom United States
Contacts
Name: Clinical Studies Department   
Address:  50 Rue Carnot 92284 Suresnes France
Telephone: +33155 72 43 66
Email: clinicaltrials@servier.com
Affiliation:  Institut de Recherches Internationales Servier
Name: Clinical Studies Department   
Address:  50 Rue Carnot 92284 Suresnes France
Telephone: +33155 72 43 66
Email: clinicaltrials@servier.com
Affiliation:  Institut de Recherches Internationales Servier
Key inclusion & exclusion criteria
Inclusion criteria:
- Diagnosis of non-infectious intermediate, posterior, or pan-uveitis in at least one eye fulfilling the International Study Group Classification Criteria ([SUN] criteria) of intermediate, posterior, or pan- uveitis confirmed by documented medical history
- Controlled uveitic disease in both eyes, defined by no active inflammatory chorioretinal and/or inflammatory retinal vascular lesions, anterior chamber cell grade = 0.5+ according to SUN criteria, Vitrous Haze grade = 0.5+ according to the SUN/NEI Scoring for Vitrous Haze,
- Best Corrected Visual Acuity of 35 letters or more in both eyes,
- Patients with a stable dose of oral corticosteroids, alone or in combination with selected stable immunosuppressive therapy .
- 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:
- Infectious uveitis and masquerade syndromes
- Isolated anterior uveitis
- Best corrected visual acuity < 35 letters in both eyes or monocular vision
- Presence of severe cataract or severe posterior capsular opacification.
- Contraindication to mydriatics or presence of posterior synechiae, in either eye.
- Active TB disease.
- History of severe allergic or anaphylactic reactions to monoclonal antibodies
- History of malignancy within 5 years prior to Selection.
- Infectious disease.
- Known immunodeficiency.
- Pregnancy, breastfeeding or possibility to become pregnant during the study


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Non-infectious Intermediate, Posterior, or Pan- Uveitis
MedDRA version: 17.1 Level: PT Classification code 10022557 Term: Intermediate uveitis System Organ Class: 10015919 - Eye disorders
MedDRA version: 17.1 Level: PT Classification code 10069034 Term: Tubulointerstitial nephritis and uveitis syndrome System Organ Class: 10038359 - Renal and urinary disorders
MedDRA version: 17.1 Level: LLT Classification code 10036370 Term: Posterior uveitis System Organ Class: 100000004862
MedDRA version: 17.1 Level: LLT Classification code 10071139 Term: Behcet's uveitis System Organ Class: 100000004866
MedDRA version: 17.1 Level: LLT Classification code 10042745 Term: Sympathetic uveitis System Organ Class: 10015919 - Eye disorders
MedDRA version: 17.1 Level: PT Classification code 10012692 Term: Diabetic uveitis System Organ Class: 10015919 - Eye disorders
MedDRA version: 17.1 Level: PT Classification code 10046851 Term: Uveitis System Organ Class: 10015919 - Eye disorders
Therapeutic area: Diseases [C] - Eye Diseases [C11]
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: XOMA 052
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 60-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use

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: XOMA 052
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 30-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use

Primary Outcome(s)
Primary end point(s): Proportion of subjects with an occurence of uveitic disease
Secondary Objective: The secondary objectives are to assess the effect of gevokizumab on the other efficacy endpoints and to evaluate its safety.
Main Objective: The objective of this study is to demonstrate the superiority of gevokizumab compared to placebo in reducing the risk of recurrent uveitic disease in subjects with non-infectious intermediate, posterior, or pan- uveitis currently controlled with systemic treatment.
Timepoint(s) of evaluation of this end point: From inclusion to D168
Secondary Outcome(s)
Secondary end point(s): - Time to first occurence of uveitic disease,
- Mean change from baseline BCVA at D168
- Proportion of subjects who reach zero corticosteroids without an occurence of uveitic disease
- Ophthalmologic assessments (visual acuity, vitreous haze score, ...)
- Safety measurements (adverse events, optical coherence tomography, intraocular pressure, vital signs, chest X rays, standard 12-lead ECG, laboratory parameters,...)
Timepoint(s) of evaluation of this end point: -Ophthalmologic endpoints: at each visit until D168, and at D280, D392, OL-0, OL-112, and OL-224.
-Safety measurements : from selection to the end of the trial.
Secondary ID(s)
X052131/CL3-78989-006
2012-001609-25-DE
NCT01747538
Source(s) of Monetary Support
XOMA US LLC
ADIR
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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