The primary objective of this study is to assess the safety and efficacy of voclosporin as therapy in subjects with active noninfectious uveitis involving the intermediate and/or posterior segments of the eye (i.e., anterior + intermediate-, intermediate-, posterior- or pan-uveitis).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
155
Subjects will be sequentially assigned to one of the following treatment arms in a 1:1 ratio: * Treatment Arm A: voclosporin 0.4 mg/kg p.o. b.i.d., not to exceed 40 mg p.o. b.i.d. * Treatment Arm B: placebo p.o. b.i.d. Dosage Form: • Soft gelatin capsule Duration of treatment: • 24 weeks
The change from baseline in graded vitreous haze in the study eye at 12 weeks of therapy or at the time of treatment failure, if earlier.
Time frame: 12 weeks
Daily mean systemic corticosteroid dose used during Weeks 12-24
Time frame: Weeks 12-24
Time to augmentation with corticosteroid therapy.
Time frame: Week 24
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Peoria, Arizona, United States
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Phoenix, Arizona, United States
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Little Rock, Arkansas, United States
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Beverly Hills, California, United States
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Mountain View, California, United States
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Sacramento, California, United States
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Santa Ana, California, United States
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Torrance, California, United States
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Indianapolis, Indiana, United States
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Ellsworth, Maine, United States
...and 42 more locations