Safety and Efficacy Study of Gevokizumab to Treat Active Non-infectious Uveitis
Phase 3
Terminated
- Conditions
- Uveitis
- Interventions
- Registration Number
- NCT01684345
- Lead Sponsor
- XOMA (US) LLC
- Brief Summary
The purpose of this study is to evaluate the efficacy of gevokizumab in the treatment of active non-infectious intermediate, posterior, or pan- uveitis.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 200
Inclusion Criteria
- Diagnosis of non-infectious intermediate, posterior, or pan- uveitis in at least one eye
- Active uveitic disease in at least one eye
- Currently on one of the following stable treatment regimens for uveitis: oral corticosteroids; systemic immunosuppressive medication; a combination of oral corticosteroids with at least one systemic immunosuppressive medication
- Effective contraceptive measures
Exclusion Criteria
- Infectious uveitis and masquerade syndromes
- Isolated anterior uveitis
- Contraindication to mydriatics
- History of allergic or anaphylactic reactions to monoclonal antibodies
- Active tuberculosis disease
- History of recurrent infection or predisposition to infection; active ocular infection
- Pregnant or nursing women
Other protocol-defined inclusion/exclusion criteria may apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo - Dose 1 gevokizumab Dose 1 gevokizumab - Dose 2 gevokizumab Dose 2 gevokizumab -
- Primary Outcome Measures
Name Time Method The proportion of responders at Day 56 Day 56 A response is defined as an improvement of the study eye without deterioration in the contralateral eye.
- Secondary Outcome Measures
Name Time Method