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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT01095250
• Date of registration: 25/03/2010
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharmaceuticals
• Public title: Safety and Efficacy of AIN457 in Patients With Active Non-infectious Uveitis INSURE
• Scientific title: 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)
• Date of first enrolment: April 2010
• Target sample size: 30
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT01095250
• Study type: Interventional
• Phase: Phase 3

Countries of recruitment

Canada, Egypt, France, Germany, Greece, Hungary, India, Israel, Italy, Japan, Singapore, Spain, Switzerland, Turkey, United Kingdom, United States

Contacts

• Name: Novartis Pharmaceuticals
• Affiliation: Novartis Pharmaceuticals

Key inclusion & exclusion criteria

Inclusion Criteria:

- Male and female subjects =18 years of age. Where relevant, parents will also sign the
informed consent according to local laws and regulations

- Patients with diagnosis of chronic non-infectious intermediate uveitis, posterior
uveitis or panuveitis in at least one eye

- Evidence of active intermediate, posterior or panuveitis (grade = 2+ vitreous haze
with or without the presence of anterior chamber cells) at screening and baseline in
at least one eye

- Requirement for any of the following immunosuppressive therapies for the treatment or
prevention of uveitis:

- Prednisone or equivalent =10 mg daily at any time within the past 3 months.

- =1 periocular injection or =1 intravitreal corticosteroid injection (e.g.
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.

- 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/disease

- Patients receiving or that may require prednisone (or equivalent) =1.5 mg/kg/day for
the treatment of their active uveitis

- 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 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

- Treatment with intravitreal anti-VEGF agents administered to the study eye within 3
months prior to screening

- Treatment with fluocinolone acetonide implant 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

- 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)

- 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

- Any previous treatment with AIN457

- 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Uveitis

Intervention(s)

Drug: Placebo

Drug: AIN457

Primary Outcome(s)

Mean Change in Vitreous Haze Grade in the Study Eye From Baseline to 28 Weeks or at Time of Rescue, if Earlier. [Time Frame: baseline to 28 weeks]

Secondary Outcome(s)

Change in Immunosuppressive Medication Score From Baseline to Week 28 [Time Frame: baseline to 28 weeks]

Mean Change in Vitreous Haze Grade and Anterior Chamber Cell Grade From Baseline to 28 Weeks [Time Frame: baseline to 28 weeks]

Proportion of Responders With no Recurrence of Active Intermediate, Posterior, or Panuveitis in the Study Eye at 28 Weeks [Time Frame: baseline to 28 weeks]

Change From Baseline in Quality of Life/Patient Reported Outcome Assessments [Time Frame: baseline to 28 weeks]

Mean Change in Best Corrected Visual Acuity From Baseline to 28 Weeks [Time Frame: baseline to 28 weeks]

Secondary ID(s)

CAIN457C2302

2009-014834-22

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 03/11/2015
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01095250