Behçet?s disease uveitis Skin and Connective Tissue Diseases Behçet's disease
Conditions
Interventions
Three open treatment arms on top of stable background treatment for a one year period, with either :
Gevokizumab
1. Dose 1 intravenous (IV) followed by monthly dose 1 subcutaneous (SC), or
2. Dose 1
Sponsors
Institut de Recherches Internationales Servier (France)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with uveitis associated with Behçet's disease diagnosis fulfilling the International Study Group Classification Criteria 2. Male or female, age [18 or legal age of majority- 80] years old 3. Stable regimen of oral corticosteroids and at least one immunosuppressive treatment
Exclusion criteria
Exclusion criteria: 1. Infectious uveitis, uveitis due to causes other than Behçet's disease, or uveitis of unknown origin 2. Cataract so severe that an assessment of the posterior segment of the uvea and the fundus is inadequate or impossible 3. History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety evaluation throughout the study 1. Adverse events 2. Vital signs 3. Laboratory values 4. Standard 12-lead electrocardiograms (ECGs) and chest X-ray at baseline and at study end | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Pharmacokinetics from baseline until the study end (serum samples) 2. Ophthalmological assessments | — |
Countries
Korea, South, Tunisia, Turkey
Outcome results
None listed