A Study of LX211 in Active Sight Threatening, 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 active non-infectious uveitis

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

Conditions
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Uveitis, Posterior, Uveitis, Intermediate, 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: Documented history of non-infectious intermediate-, anterior and intermediate-, posterior- or panuveitis uveitis Current uveitis therapy must conform to one of the following: Prednisone monotherapy at a dose of ≥ 10 mg/day (or equivalent) for ≥ 2 weeks prior to randomization Have received ≥ 2 injections of corticosteroid (intravitreal or periocular) for control of disease within the past 8 months, but not within 2 weeks of randomization; subjects may also be receiving systemic corticosteroid therapy Receiving monotherapy with azathioprine, mycophenolate mofetil, mycophenolic acid or methotrexate for at least 2 weeks prior to randomization Receiving prednisone in addition to one immunomodulatory agent from among cyclosporine, tacrolimus, azathioprine, mycophenolate mofetil, mycophenolic acid and methotrexate for at least 2 weeks prior to randomization Subjects for whom corticosteroid therapy (systemic or local) is medically inappropriate or who refuse corticosteroid therapy Grade of 2+ or higher for vitreous haze at time of enrollment Considered by the investigator to require immunomodulatory therapy. Not planning to undergo elective ocular surgery during the study Exclusion Criteria: Uveitis of infectious etiology Clinically suspected or confirmed central nervous system or ocular lymphoma 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 |
| --- | --- | --- |
| vitreous haze |  | 16 and 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BCVA |  | 24 weeks | 

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