Safety and Efficacy of AIN457 in Patients With Active Non-infectious Uveitis (INSURE)

Phase 3

Conditions: Health Condition 1: null- Uveitis

Registration Number: CTRI/2010/091/000479

Lead Sponsor: ovartis Healthcare Pvt Ltd

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Other (Terminated)

Sex: Not specified

Target Recruitment: 208

Inclusion Criteria

Male and female subjects greater than or equal to 18 years of age. Where relevant, parents will also sign the

informed consent according to local laws and regulations.

2. Patients with diagnosis of chronic non infectious intermediate uveitis, posterior uveitis or

panuveitis in at least one eye

3. Evidence of active intermediate, posterior or panuveitis (grade greater than or equal to 2+ vitreous haze with or

without the presence of anterior chamber cells) at screening and baseline in at least one eye

4. Requirement for any of the following immunosuppressive therapies for the treatment or

prevention of uveitis

• Prednisone or equivalent greater than or equal to 10 mg daily at any time within the past 3 months

• Greater than or equal to 1 periocular injection or greater than or equal to 1 intravitreal corticosteroid injection (i.e. triamcinolone) in the

study eye within the past 6 months (the last injection must not have been given 6 weeks

prior to screening)

• Treatment with either cyclosporine, tacrolimus, azathioprine, mycophenolate mofetil,

mycophenolic acid, methotrexate at any time within the past 3 months. (Patients

treated with chlorambucil or cyclophosphamide within the past 5 years are ineligible for

the study)

• Patients not meeting the above specified criteria for immunosuppressive

therapies are eligible for enrollment if they are intolerant to systemic

immunosuppressive therapy as determined by the study investigator

5. Patient must be able to understand and communicate with the investigator and comply with

the requirements of the study and must give a written, signed, and dated informed consent

before any study assessment is performed

Exclusion Criteria

Ocular concomitant conditions or disease

1. Patients receiving or that may require prednisone (or equivalent) greater than or equal to 1.5 mg/kg/day for the

treatment of their active uveitis.

2.Patients with a primary diagnosis of BehÃ§ets disease, anterior uveitis, or any intermediate

uveitis, posterior uveitis or panuveitis in which the manifestation(s) of the active intraocular

inflammatory disease may spontaneously resolve or that are not characterized by the

presence of either anterior chamber cells or vitritis (vitreous cell and haze) such as the white

dot retino-choroidopathies (e.g. punctuate inner choroidopathy (PIC), acute zonal occult outer

retinopathy (AZOOR)

3. Patients with infectious uveitis or uveitis of an underlying diagnosis that is uncertain and

would reasonably include a disease for which immunosuppression would be contraindicated

(e.g. ocular lymphoma).

Ocular treatments

4. Treatment with intravitreal antiVEGF agents administered to the study eye within 3 months

prior to screening.

5. Treatment with fluocinolone acetonide implant (RetisertÂ®) in the study eye within the last 3

years, or dexamethasone intravitreal implant and any other investigational corticosteroid

implants in the study eye within the last 6 months.

6. Intraocular surgery or laser photocoagulation in the study eye within the last 6 weeks prior to

screening except for a diagnostic vitreous or aqueous tap with a small-gauge needle.

7. Planned elective ocular surgery during the study.

8. Ocular disease that would interfere with ocular evaluations (e.g. corneal scarring, cataract,

vitreous hemorrhage) or that in the opinion of the investigator would complicate the evaluation

of the safety or efficacy of the study treatment (e.g. uncontrolled glaucoma, toxoplasma scar,

macular scarring).

9. Current use of or likely need for systemic medications known to be toxic to the lens, retina, or

optic nerve (e.g., deferoxamine, chloroquine, ethambutol, etc.)

Systemic conditions or treatments

10. Any previous treatment with AIN457

11. Any systemic biologic therapy (e.g. interferon, infliximab, daclizumab, etanercept, or

adalimumab) given intravenously or subcutaneously within 3 months prior to screening. No

biologic therapy other than the investigational study treatment will be allowed during the

course of the clinical trial.

12. Any prior treatment with systemic alkylating agents (cyclophosphamide, chlorambucil) within

the past 5 years prior to screening.

13. Treatment with any live or live attenuated vaccine (including vaccine for varicella-zoster or

measles) within 2 months prior to screening. No treatment with live or live attenuated

vaccines will be allowed during the course of the clinical trial.

14. Active systemic infections during the last two weeks prior to screening (exception. common

cold)

15. Underlying metabolic, hematologic, renal, hepatic, infectious or gastrointestinal conditions

which in the opinion of the investigator immunocompromises the patient and/or places the

patient at an unacceptable risk for participation in an immunomodulatory therapy.

16. Systemic or extraocular disease that would contraindicate long-term immunosuppression,

especial

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean change in vitreous haze grade in the study eye from baseline to 28 weeks or at time of rescue, if earlier.Timepoint: baseline to 28 weeks

Secondary Outcome Measures

Name	Time	Method
? Change from baseline in Quality of Life/Patient reported outcome assessmentsTimepoint: baseline to 28 weeks;? change in immunosuppressive medication score from baseline to Week 28Timepoint: baseline to 28 weeks;? Mean change in best corrected visual acuity from baseline to 28 weeksTimepoint: baseline to 28 weeks;? Mean change in vitreous haze grade and anterior chamber cell grade from baseline to 28 weeksTimepoint: baseline to 28 weeks;? Proportion of responders with no recurrence of active intermediate, posterior, or panuveitis in the study eye at 28 weeksTimepoint: baseline to 28 weeks