Efficacy and Safety of Voclosporin to Treat Active Noninfectious Uveitis

Study Overview
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Brief Summary
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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).

Official Title
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A Multi-Center, Double-Masked, Parallel-Group, Placebo-Controlled Study to Assess the Efficacy and Safety of Voclosporin as Therapy in Subjects With Active Noninfectious Uveitis Involving the Intermediate and/or Posterior Segments of the Eye

Conditions
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Noninfectious Uveitis

Intervention / Treatment
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* Drug: LX211


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Active noninfectious uveitis involving the intermediate and/or posterior segment (i.e., anterior + intermediate-, intermediate-, posterior- or pan-uveitis) in at least one eye as evidenced by a vitreous haze grade of at least 2+ at the baseline visit. Subjects who also have anterior segment involvement need not be excluded if otherwise qualified. Subjects must be: Capable of understanding the purpose and risks of the study. Able to give written informed consent. Able to comply with all study requirements. Exclusion Criteria: Ocular Disease/Conditions The following conditions are exclusionary if present: Uveitis limited to only the anterior segment of the study eye. Confirmed or suspected infectious uveitis in either eye. Prior and Current Treatment: - As defined in the protocol Extraocular Conditions: - As defined in the protocol. Laboratory, Blood Pressure and ECG Evaluations: As defined in the protocol.

Ages Eligible for Study
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Minimum Age: 18 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 |
| --- | --- |
| Experimental: LX211<br> | Drug: LX211<br>* 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<br>|
| Placebo Comparator: Placebo<br> | Drug: LX211<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Daily mean systemic corticosteroid dose used during Weeks 12-24 |  | Weeks 12-24 | 
| Time to augmentation with corticosteroid therapy. |  | Week 24 |