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

This study has been terminated.
(Study in Behcet's disease with mostly active uveitis did not meet its primary endpoint. A smaller dose-finding study in active uveitis is being planned.)
Sponsor:
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT01095250
First received: March 25, 2010
Last updated: May 2, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention Phase
Uveitis
Biological: AIN457
Biological: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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)

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Mean change in best corrected visual acuity from baseline to 28 weeks [ Time Frame: baseline to 28 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in Quality of Life/Patient reported outcome assessments [ Time Frame: baseline to 28 weeks ] [ Designated as safety issue: No ]
  • Mean change in vitreous haze grade and anterior chamber cell grade from baseline to 28 weeks [ Time Frame: baseline to 28 weeks ] [ Designated as safety issue: No ]
  • change in immunosuppressive medication score from baseline to Week 28 [ Time Frame: baseline to 28 weeks ] [ Designated as safety issue: No ]

Enrollment: 31
Study Start Date: April 2010
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AIN457 300mg s.c every 2 weeks Biological: AIN457
Experimental: AIN457 300mg s.c. every 4 weeks Biological: AIN457
Experimental: AIN457 150mg s.c every 4 weeks Biological: AIN457
Placebo Comparator: Placebo s.c every 2 weeks Biological: Placebo

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01095250

  Show 93 Study Locations
Sponsors and Collaborators
Novartis
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided by Novartis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT01095250     History of Changes
Other Study ID Numbers: CAIN457C2302, 2009-014834-22
Study First Received: March 25, 2010
Last Updated: May 2, 2012
Health Authority: United States: Food and Drug Administration
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Greece: National Organization of Medicines
Hungary: National Institute of Pharmacy
Canada: Health Canada
Egypt: Ministry of Health and Population
Japan: Ministry of Health, Labor and Welfare
Singapore: Department of Health 3/F, Public Health Laboratory Centre
Switzerland: Swissmedic
Germany: Paul-Ehrlich-Institut
Spain: Spanish Agency of Medicines
Italy: Comitato Etico per la Sperimentazione Clinica dei Medicinali Dell'Azienda Ospedaliero -Universitaria Careggi di Firenze
Turkey: IEGM (The General Directorate of Pharmaceuticals and Pharmacy)
United Kingdom: Medicines and Healthcare Products Regulatory Agency
India: Ministry of Health
Israel: Ministry of Health

Keywords provided by Novartis:
Active uveitis
intermediate uveitis
panuveitis
posterior uveitis
uveitis

Additional relevant MeSH terms:
Chorioretinitis
Uveitis
Choroid Diseases
Choroiditis
Eye Diseases
Panuveitis
Retinal Diseases
Retinitis
Uveal Diseases
Uveitis, Posterior

ClinicalTrials.gov processed this record on November 20, 2014