Status:
TERMINATED
Efficacy and Safety Study of Gevokizumab to Treat Behcet's Disease Uveitis
Lead Sponsor:
XOMA (US) LLC
Conditions:
Behcet's Disease Uveitis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The objective of this study is to assess the efficacy and safety of gevokizumab in treating Behcet's disease uveitis (BDU).
Eligibility Criteria
Inclusion
- Have characteristics of Behcet's disease consistent with International Criteria for Behcet's disease
- Have a documented history of active uveitis with or without retinal vasculitis within the past 12 months
- Best corrected visual acuity (BCVA) \>= 20 ETDRS letters in both eyes at baseline
- Effective contraceptive measures
Exclusion
- Infectious uveitis and masquerade syndromes
- End stage ocular disease
- 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
Key Trial Info
Start Date :
November 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2015
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT02258867
Start Date
November 1 2014
End Date
November 1 2015
Last Update
December 29 2015
Active Locations (8)
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1
Santa Ana, California, United States
2
Chicago, Illinois, United States
3
Ellsworth, Maine, United States
4
Cambridge, Massachusetts, United States