Main
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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:
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EUCTR |
Last refreshed on:
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1 February 2016 |
Main ID: |
EUCTR2012-001609-25-PL |
Date of registration:
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01/07/2014 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Efficacy and safety of gevokizumab in the treatment of patients with active non-infectious uveitis currently controlled with systemic treatment
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Scientific title:
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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:
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22/09/2014 |
Target sample size:
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300 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-001609-25 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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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
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Phase:
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Countries of recruitment
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Argentina
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Australia
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Brazil
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China
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France
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Germany
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Greece
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Hong Kong
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Italy
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Korea, Republic of
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Mexico
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Poland
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Portugal
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Russian Federation
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Spain
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Taiwan
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Tunisia
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Turkey
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United Kingdom
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United States
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Contacts
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Name:
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Clinical Studies Department
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Address:
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50 Rue Carnot
92284
Suresnes
France |
Telephone:
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+33155 72 43 66 |
Email:
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clinicaltrials@servier.com |
Affiliation:
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Institut de Recherches Internationales Servier |
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Name:
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Clinical Studies Department
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Address:
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50 Rue Carnot
92284
Suresnes
France |
Telephone:
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+33155 72 43 66 |
Email:
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clinicaltrials@servier.com |
Affiliation:
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Institut de Recherches Internationales Servier |
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Key inclusion & exclusion criteria
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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
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Health Condition(s) or Problem(s) studied
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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
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Therapeutic area: Diseases [C] - Eye Diseases [C11]
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Intervention(s)
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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
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Primary Outcome(s)
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Primary end point(s): Proportion of subjects with an occurence of uveitic disease
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Secondary Objective: The secondary objectives are to assess the effect of gevokizumab on the other efficacy endpoints and to evaluate its safety.
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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.
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Timepoint(s) of evaluation of this end point: From inclusion to D168
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Secondary Outcome(s)
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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,...)
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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.
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Secondary ID(s)
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X052131/CL3-78989-006
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2012-001609-25-DE
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NCT01747538
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Source(s) of Monetary Support
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XOMA US LLC
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ADIR
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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