Extension Study to Assess Safety and Efficacy of AIN457 in Patients With Active Non-infectious Uveitis

Study Overview
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Brief Summary
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The purpose of the extension study was to provide patients completing the 28-week core study (NCT01095250) with an opportunity to receive an additional 22 weeks of continuous treatment.

Official Title
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A 34-week Extension to a 28-week Multicenter, Randomized, Double-masked, Placebo Controlled, Dose-ranging Phase III Study to Assess AIN457 Versus Placebo in Inducing and Maintaining Uveitis Suppression in Adults With Active, Non-infectious, Intermediate, Posterior, or Panuveitis Requiring Immunosuppression (INSURE Study)

Conditions
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Uveitis

Intervention / Treatment
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* Biological: AIN457
* Biological: AIN457
* Biological: AIN457
* Biological: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who have completed the entire treatment period of the 28-week core study 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 study treatment in the extension study Exclusion Criteria: Inability or unwillingness to undergo repeated subcutaneous injections Inability to comply with study or follow-up procedures Any medical or psychiatric condition which, in the investigator's opinion would preclude the participant from adhering to the protocol or completing the study per protocol Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (> 5 mIU/mL) Women of childbearing potential (WoCBP), defined as all women physiologically capable of becoming pregnant, UNLESS They are using simultaneously double barrier or two acceptable methods of contraception They are postmenopausal with an appropriate clinical profile and had no regular menstrual bleeding for at least twelve (12) months prior to initial dosing They have undergone reliable surgical sterilization at least six (6) months prior to initial dosing Their career, lifestyle, or sexual orientation precludes intercourse with a male partner Partners have been sterilized by vasectomy or other reliable means 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: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AIN457 300mg s.c every 2 weeks<br> | Biological: AIN457<br> <br> |
| Experimental: AIN457 300mg s.c every 4 weeks<br> | Biological: AIN457<br> <br> |
| Experimental: AIN457 150mg s.c every 4 weeks<br> | Biological: AIN457<br> <br> |
| Placebo Comparator: Placebo s.c every 2 weeks<br> | Biological: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of recurrence |  | baseline to 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in immunosuppressive medication score from core study baseline |  | baseline to 52 weeks | 
| Time to recurrence after the initial induction of quiescence (≤ 0.5+ anterior chamber cell grade and ≤ 0.5+ vitreous haze grade) by study treatment or rescue medication |  | baseline to 52 weeks | 
| Mean change in best corrected visual acuity from baseline |  | baseline to 52 weeks | 
| Change from baseline in Quality of Life/Patient reported outcome assessments |  | baseline to 52 weeks | 
| Mean change in vitreous haze grade and anterior chamber cell grade from baseline to 52 weeks |  | baseline to 52 weeks | 

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