NCT01684345TerminatedPhase 3
A Randomized, Double-masked, Placebo-controlled Study of the Safety and Efficacy of Gevokizumab in the Treatment of Active Non-infectious Intermediate, Posterior, or Pan- Uveitis
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Terminated
- Sponsor
- XOMA (US) LLC
- Enrollment
- 200
- Primary Endpoint
- The proportion of responders at Day 56
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Placebo
Placebo Comparator
Intervention: Placebo (Drug)
Dose 1 gevokizumab
Experimental
Intervention: Dose 1 gevokizumab (Drug)
Dose 2 gevokizumab
Experimental
Intervention: Dose 2 gevokizumab (Drug)
Outcomes
Primary Outcomes
The proportion of responders at Day 56
Time Frame: Day 56
A response is defined as an improvement of the study eye without deterioration in the contralateral eye.
Secondary Outcomes
No secondary outcomes reported
Investigators
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