Study to Evaluate the Long Term Use of Treatment With AIN457 for Uveitis

Study Overview
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Brief Summary
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This study will provide patients who have completed the AIN457 Phase II and Phase III clinical trials in non-infectious uveitis continued access to treatment with AIN457 while collecting safety data and information on long term clinical use of treatment with AIN457.

Official Title
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A Multicenter, Open-label Study to Evaluate the Long Term Clinical Use of Treatment With AIN457 in Patients Completing Clinical Trials Investigating AIN457 for the Treatment of Non-infectious Intermediate, Posterior or Panuveitis

Conditions
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Uveitis

Intervention / Treatment
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* Biological: AIN457


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients must be able to understand and communicate with the investigator and comply with the requirements for the study and must give a written, signed, and dated informed consent before any study assessment is performed Patient is currently enrolled in CAIN457A2208 or has completed the core and extension study treatment periods in the ongoing AIN457 phase III clinical trial Studies (e.g., CAIN457C2301 and CAIN457C2301E1) Willingness to discontinue AIN457 or be weaned from standard of care immunosuppressive therapy if recommended by the study investigator Exclusion Criteria: Need for treatment with ocular procedures or systemic medications prohibited in this study including an alkylating agent or another biologic therapy other than AIN457 Pregnant or nursing (lactating) women Women of childbearing potential unwilling to use protocol defined acceptable methods of contraception throughout the study and for 16 weeks after study drug discontinuation Other protocol-defined inclusion/exclusion criteria may apply

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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AIN457 300mg s.c every 2 weeks<br> | Biological: AIN457<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participants with adverse events as a measure of safety and tolerability |  | up to 36 months | 
| Proportion of patients achieving the criteria for clinically inactive posterior segment uveitis |  | up to 36 months | 
| Mean time to achieve the criteria for clinically inactive posterior segment uveitis |  | up to 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients experiencing clinically active posterior segment uveitis in patients discontinuing AIN457 treatment |  | up to 36 months | 
| Time to recurrence of clinically active posterior segment uveitis after discontinuation of AIN457 treatment |  | up to 36 months | 
| Time to resolution of a recurrence of clinically active posterior segment uveitis in patients discontinuing AIN457 and treated only with the reinitiation of AIN457 |  | up to 36 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Quiescent uveitis, intermediate uveitis, panuveitis, posterior uveitis, uveitis