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

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ClinicalTrials.gov Identifier: NCT01095250
Recruitment Status : Terminated (Terminated: Study in Behcet's disease with mostly active uveitis did not meet its primary endpoint.)
First Posted : March 30, 2010
Results First Posted : November 3, 2015
Last Update Posted : November 3, 2015
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Uveitis Drug: AIN457 Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, 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)
Study Start Date : April 2010
Actual Primary Completion Date : October 2010
Actual Study Completion Date : October 2010

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: AIN457 300mg s.c every 2 weeks
AIN457 300 mg s.c. at baseline, Week 1 and Week 2, then every 2 weeks.
 Drug: AIN457
Experimental: AIN457 300mg s.c. every 4 weeks
AIN457 300 mg s.c. at baseline and Week 2, then every 4 weeks.
 Drug: AIN457
Experimental: AIN457 150mg s.c every 4 weeks
AIN457 150 mg s.c. at baseline and Week 2, then every 4 weeks
 Drug: AIN457
Placebo Comparator: Placebo s.c every 2 weeks
Placebo s.c at baseline, Week 1 and Week 2, then every 2 weeks
 Drug: Placebo


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
    No patients of Study CAIN457C2303 achieved the milestone of the primary endpoint in non-infectious uveitis patients with Behçet's disease. Study CAIN457C2302 (active uveitis study) was terminated to avoid continuing patients on a study with a low probability of success.Since patients did not reach the endpoint of analysis there can be no meaningful interpretation of data and data will be not provided.


Secondary Outcome Measures :
  1. 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 ]
    No patients of Study CAIN457C2303 achieved the milestone of the primary endpoint in non-infectious uveitis patients with Behçet's disease. Study CAIN457C2302 (active uveitis study) was terminated to avoid continuing patients on a study with a low probability of success.Since patients did not reach the endpoint of analysis there can be no meaningful interpretation of data and data will be not provided.

  2. Mean Change in Best Corrected Visual Acuity From Baseline to 28 Weeks [ Time Frame: baseline to 28 weeks ]
    No patients of Study CAIN457C2303 achieved the milestone of the primary endpoint in non-infectious uveitis patients with Behçet's disease. Study CAIN457C2302 (active uveitis study) was terminated to avoid continuing patients on a study with a low probability of success.Since patients did not reach the endpoint of analysis there can be no meaningful interpretation of data and data will be not provided.

  3. Change From Baseline in Quality of Life/Patient Reported Outcome Assessments [ Time Frame: baseline to 28 weeks ]
    No patients of Study CAIN457C2303 achieved the milestone of the primary endpoint in non-infectious uveitis patients with Behçet's disease. Study CAIN457C2302 (active uveitis study) was terminated to avoid continuing patients on a study with a low probability of success.Since patients did not reach the endpoint of analysis there can be no meaningful interpretation of data and data will be not provided.

  4. Mean Change in Vitreous Haze Grade and Anterior Chamber Cell Grade From Baseline to 28 Weeks [ Time Frame: baseline to 28 weeks ]
    No patients of Study CAIN457C2303 achieved the milestone of the primary endpoint in non-infectious uveitis patients with Behçet's disease. Study CAIN457C2302 (active uveitis study) was terminated to avoid continuing patients on a study with a low probability of success.Since patients did not reach the endpoint of analysis there can be no meaningful interpretation of data and data will be not provided.

  5. Change in Immunosuppressive Medication Score From Baseline to Week 28 [ Time Frame: baseline to 28 weeks ]
    No patients of Study CAIN457C2303 achieved the milestone of the primary endpoint in non-infectious uveitis patients with Behçet's disease. Study CAIN457C2302 (active uveitis study) was terminated to avoid continuing patients on a study with a low probability of success.Since patients did not reach the endpoint of analysis there can be no meaningful interpretation of data and data will be not provided.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01095250


Locations
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United States, California
Novartis Investigative Site
Beverly Hills, California, United States, 90211
United States, Massachusetts
Novartis Investigative Site
Cambridge, Massachusetts, United States, 02142
United States, New York
Novartis Investigative Site
Slingerlands, New York, United States, 12159
United States, Texas
Novartis Investigative Site
Arlington, Texas, United States, 76012
Novartis Investigative Site
Houston, Texas, United States, 77025
Canada, Ontario
Novartis Investigative Site
London, Ontario, Canada, N6A 4G5
Novartis Investigative Site
North York, Ontario, Canada, M3N 2V6
Canada, Quebec
Novartis Investigative Site
Montreal, Quebec, Canada, H3A 1A1
Egypt
Novartis Investigative Site
Cairo, Egypt
France
Novartis Investigative Site
Nantes, France, 44093
Germany
Novartis Investigative Site
Freiburg, Germany, 79106
Novartis Investigative Site
Göttingen, Germany, D-37075
Hungary
Novartis Investigative Site
Budapest, Hungary, 1083
India
Novartis Investigative Site
Ahmedabad, Gujarat, India, 380004
Israel
Novartis Investigative Site
Afula, Israel, 18101
Novartis Investigative Site
Petach Tikva, Israel, 49100
Novartis Investigative Site
Ramat Gan, Israel, 52621
Novartis Investigative Site
Tel-Aviv, Israel, 64239
Japan
Novartis Investigative Site
Fukuoka-city, Fukuoka, Japan, 812-8582
Novartis Investigative Site
Fukushima-city, Fukushima, Japan, 960-1295
Novartis Investigative Site
Sapporo-city, Hokkaido, Japan, 060-8648
Novartis Investigative Site
Osaka-city, Osaka, Japan, 545-8586
Novartis Investigative Site
Suita-city, Osaka, Japan, 565-0871
Novartis Investigative Site
Shimotsuka-gun, Tochigi, Japan, 321-0293
Novartis Investigative Site
Bunkyo-ku, Tokyo, Japan, 113-8655
Novartis Investigative Site
Mitaka-city, Tokyo, Japan, 181-8611
Novartis Investigative Site
Kyoto, Japan, 602-8566
Singapore
Novartis Investigative Site
Singapore, Singapore, 308433
Spain
Novartis Investigative Site
Barcelona, Catalunya, Spain, 08035
Novartis Investigative Site
Barcelona, Catalunya, Spain, 08036
Switzerland
Novartis Investigative Site
Lausanne, CHE, Switzerland, 1004
Novartis Investigative Site
Bern, Switzerland, 3010
Novartis Investigative Site
Bern, Switzerland, 3012
Novartis Investigative Site
Luzern, Switzerland, 6000
Novartis Investigative Site
St. Gallen, Switzerland, 9007
United Kingdom
Novartis Investigative Site
York, United Kingdom, YO31 8HE
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01095250    
Other Study ID Numbers: CAIN457C2302
2009-014834-22
First Posted: March 30, 2010    Key Record Dates
Results First Posted: November 3, 2015
Last Update Posted: November 3, 2015
Last Verified: October 2015
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Active uveitis
intermediate uveitis
panuveitis
posterior uveitis
uveitis
Additional relevant MeSH terms:
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Uveitis
Uveal Diseases
Eye Diseases
 Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs