Safety and Efficacy Study of Gevokizumab to Treat Non-infectious Uveitis Controlled With Systemic Treatment
Phase 3
Terminated
- Conditions
- Uveitis
- Interventions
- Registration Number
- NCT01747538
- Lead Sponsor
- XOMA (US) LLC
- Brief Summary
The purpose of this study is to evaluate the efficacy of gevokizumab in reducing the risk of recurrent uveitic disease in subjects with non-infectious uveitis whose disease is currently controlled with systemic treatment.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 281
Inclusion Criteria
- Diagnosis of non-infectious intermediate, posterior, or pan- uveitis in at least one eye
- Controlled uveitic disease in both eyes
- Stable dose of oral corticosteroids in combination with selected stable immunosuppressive therapy
- Effective contraceptive measures
Exclusion Criteria
- Infectious uveitis and masquerade syndromes
- Isolated anterior uveitis
- Contraindication to mydriatics
- Active tuberculosis disease
- History of allergic or anaphylactic reactions to monoclonal antibodies
- 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 Proportion of subjects with an occurrence of uveitic disease through Day 168 Day 0 through Day 168
- Secondary Outcome Measures
Name Time Method Time to first occurrence of uveitic disease Day 0 through Day 168