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Efficacy of Gevokizumab in the Treatment of Patients With Behçet's Disease Uveitis (EYEGUARD™-B) (EYEGUARD™-B)
Servier Protocol Code:
CL3-78989-002
Sponsor:
Institut de Recherches Internationales Servier
Clinicaltrials.gov Identifier:
NCT01965145
EudraCT Number:
2012-001125-27
Find a recruiting site
How to participate in this study
If you think you are eligible for this study (see
below), you can identify the location closest to you and contact them directly. If you can’t find a location close to you, please contact Institut de Recherches Internationales Servier (I.R.I.S.)
eligibility criteria
Researchers look for people who fit a certain decription, called eligibility criteria. These include inclusion criteria and exclusion criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Name:
Institut de Recherches Internationales Servier, Département des études cliniques
Phone number:
+33 1 55 72 60 00
The study has 2 locations
Study description
A randomized, double-masked, placebo-controlled study of the efficacy of gevokizumab in the treatment of patients with Behçet's disease uveitis
Official title: A Randomized, Double-masked, Placebo-controlled Study of the Efficacy of Gevokizumab in the Treatment of Patients With Behçet's Disease Uveitis
Results
English (USA)Conditions
Behcet's Uveitis
Interventions / Treatments
The treatment(s) given to the participants in the study.
- Gevokizumab
- Placebo
Other study id numbers
Other identification numbers the study may be known by.
- CL3-78989-002
Eligibility Criteria
Researchers look for people who fit a certain decription, called eligibility criteria. These include inclusion criteria and exclusion criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligible age for the study
18 years and older
(Adult, Older Adult)
Sex
Male/FemaleAccepts Healthy Volunteers
No- * Behçet's disease diagnosis fulfilling the International Study Group Classification Criteria.
- * History of Behçet's disease uveitis with ocular involvement of the posterior segment.
- * Patients with a stable background treatment of oral corticosteroid and at least one immunosuppressive drug.
- * 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
- * Infectious uveitis, uveitis due to causes other than Behçet's disease.
- * Monocular vision
- * Presence of severe cataract or severe posterior capsular opacification.
- * Contraindication to mydriasis or presence of posterior synechiae.
- * Active TB disease.
- * History of severe allergic or anaphylactic reactions to monoclonal antibodies
- * History of malignancy within 5 years prior to Selection.
How is the study designed?
Allocation
How participants are assigned to different groups. Allocation can be random (randomized) or predetermined (non-randomized). Randomized means that participants are assigned at random to their participant group / arm.
Interventional study model
How treatments are given and tested in a study.
Parallel
A parallel study design compares two or more groups at the same time, with each group receiving a different treatment. Researchers then compare the results to determine which treatment is more effective.
Participant Group / Arm
A set of participants in the study who receive the same treatment or intervention.
Intervention / Treatment
The treatment(s) given to the participants in the study.
Participant Group / Arm
A set of participants in the study who receive the same treatment or intervention.
Experimental:
Gevokizumab
Solution for subcutaneous injection, Dose 1
Intervention / Treatment
The treatment(s) given to the participants in the study.
Drug:
Gevokizumab
Sterile solution administered subcutaneously
Participant Group / Arm
A set of participants in the study who receive the same treatment or intervention.
Placebo Comparator:
Placebo
Solution for subcutaneous injection, placebo
Intervention / Treatment
The treatment(s) given to the participants in the study.
Drug:
Placebo
Sterile solution administered subcutaneously