Behcet's Uveitis
Conditions
Brief summary
The objective of this study is to demonstrate the superiority of gevokizumab as compared to placebo on top of current standard of care in reducing the risk of Behçet's disease uveitis exacerbations
Detailed description
A randomized, double-masked, placebo-controlled study of the efficacy of gevokizumab in the treatment of patients with Behçet's disease uveitis
Interventions
DRUGGevokizumab
Sterile solution administered subcutaneously
DRUGPlacebo
Sterile solution administered subcutaneously
Sponsors
Institut de Recherches Internationales Servier
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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. Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to first acute ocular exacerbation | up to 3 years | number of days |
Countries
South Korea, United Kingdom
Outcome results
None listed