A Study of LX211 in Clinically Quiescent Non-infectious Intermediate, Anterior and Intermediate, Posterior or Pan-Uveitis

Study Overview
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Brief Summary
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The objective of this study is to evaluate the safety and efficacy of LX211 as therapy in subjects with clinically quiescent non-infectious uveitis

Official Title
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A Double-Masked, Placebo-Controlled, Multi-Center, Parallel-Group, Dose-Ranging Study With an Optional Extension to Assess the Efficacy and Safety of LX211 as Therapy in Subjects With Clinically Quiescent Sight Threatening, Non-infectious Intermediate, Anterior and Intermediate, Posterior or Pan-Uveitis

Conditions
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Uveitis, Intermediate, Uveitis, Posterior, Panuveitis

Intervention / Treatment
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* Drug: Placebo
* Drug: LX211
* Drug: LX211
* Drug: LX211


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A documented history of non-infectious intermediate, anterior and intermediate, posterior or panuveitis. Minimum prescribed therapy upon enrollment is one or more of the following: systemic prednisone or equivalent averaging ≥ 10 mg/day at least 2 periocular/intravitreal corticosteroid administrations for control of inflammatory disease within the previous 8 months (but not within 6 weeks of randomization). at least one, but not more than 2 immunosuppressive drugs from among the following compounds: cyclosporine, tacrolimus, azathioprine, mycophenolate mofetil, methotrexate Subjects with clinically quiescent uveitis in both eyes at enrollment and who have been on a stable treatment regimen for a minimum of 6 weeks Best-corrected distance visual acuity in the worst involved eye of 20/400 or better (ETDRS logMAR <1.34) Subjects not planning to undergo elective ocular surgery during the study Exclusion Criteria: Evidence of active, uncontrolled non-infectious uveitis Periocular administration of corticosteroids within the previous 6 weeks. Uveitis of infectious etiology Uncontrolled glaucoma Clinically suspected or confirmed central nervous system or ocular lymphoma History or diagnosis of Behçet's disease Primary diagnosis of anterior uveitis

Ages Eligible for Study
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Minimum Age: 13 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* PO BID<br>|
| Active Comparator: LX211, 0.2 mg/kg<br> | Drug: LX211<br>* 0.2 mg/kg, twice a day (BID)<br>|
| Active Comparator: LX211, 0.4 mg/kg<br> | Drug: LX211<br>* 0.4 mg/kg, twice a day (BID)<br>|
| Active Comparator: LX211, 0.6 mg/kg<br> | Drug: LX211<br>* 0.6 mg/kg, twice a day (BID)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| recurrence of ocular inflammation |  | 26 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BCVA |  | 26 weeks | 
| systemic corticosteroid usage |  | 26 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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uveitis, calcineurin