Safety and Efficacy of AIN457 in Patients With Quiescent Non-infectious Uveitis
Condition: Non-infectious Uveitis
MeSH terms: Uveitis
Intervention: AIN457; AIN457; AIN457; Placebo
Intervention description: AIN457 300mg s.c weekly for 3 weeks then every 2 weeks; AIN457 300mg s.c at baseline and Week 2 then every 4 weeks; AIN457 150mg s.c at baseline and Week 2 then every 4 weeks; Placebo s.c weekly for 3 weeks then every 2 weeks
Intervention MeSH terms: Antibodies, Monoclonal
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 125.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Quiescent uveitis; intermediate uveitis; panuveitis; posterior uveitis; uveitis

Summary:

      This study will assess the safety and efficacy of AIN457 as adjunctive therapy for the
      treatment of intermediate uveitis, posterior uveitis, or panuveitis requiring systemic
      immunosuppression.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with quiescent chronic, non-infectious intermediate uveitis, posterior
             uveitis or panuveitis as evidenced by <1+ anterior chamber cell grade and <1+ vitreous
             haze in both eyes for at least 6 weeks prior to screening.

          -  Requirement for either of the following immunosuppressive therapies at any time within
             the past 3 months for the treatment or prevention of uveitis which must not have been
             increased within the 6 weeks prior to screening:

        Prednisone or equivalent ≥10 mg daily.

        ≥1 periocular injection or ≥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 as monotherapy or in combination with or without steroids.
        (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.

        Exclusion Criteria:

        Ocular concomitant conditions/disease

          -  Patients with a primary diagnosis of Behcet's 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 (i.e. Punctate inner
             choroidopathy (PIC), acute zonal occult outer retinopathy (AZOOR.)

          -  Patients with active, non-infectious intermediate, posterior or panuveitis in one or
             both eyes (≥1+ anterior chamber cells and /or ≥1+ vitreous haze.)

          -  Patients receiving or that may require corticosteroids (prednisone or equivalent) ≥1
             mg/kg/day to maintain quiescence of their intraocular inflammation.

        Ocular treatments

          -  Treatment with intravitreal anti-VEGF agents administered to the study eye within 3
             months prior to screening.

          -  Treatment with fluocinolone acetonide implant (Retisert®) 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.

          -  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.

        Systemic conditions or treatments

          -  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.

          -  Any prior treatment with systemic alkylating agents (cyclophosphamide, chlorambucil)
             within the past 5 years prior to screening.

          -  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.

        Other protocol-defined inclusion/exclusion criteria may apply