Safety and Efficacy of AIN457 in Patients With Quiescent Non-infectious Uveitis
NCT ID: NCT01032915
Last Updated: 2015-11-05
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
125 participants
INTERVENTIONAL
2010-02-28
2011-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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AIN457 300mg s.c weekly for 3 weeks
AIN457 300mg s.c weekly for 3 weeks then every 2 weeks
AIN457
AIN457 300mg s.c weekly for 3 weeks then every 2 weeks
AIN457 300mg s.c at baseline and Week 2
AIN457 300mg s.c at baseline and Week 2 then every 4 weeks
AIN457
AIN457 300mg s.c at baseline and Week 2 then every 4 weeks
AIN457 150mg s.c at baseline and Week 2
AIN457 150mg s.c at baseline and Week 2 then every 4 weeks
AIN457
AIN457 150mg s.c at baseline and Week 2 then every 4 weeks
Placebo s.c weekly for 3 weeks
Placebo s.c weekly for 3 weeks then every 2 weeks
Placebo
Placebo s.c weekly for 3 weeks then every 2 weeks
Interventions
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AIN457
AIN457 300mg s.c weekly for 3 weeks then every 2 weeks
AIN457
AIN457 300mg s.c at baseline and Week 2 then every 4 weeks
AIN457
AIN457 150mg s.c at baseline and Week 2 then every 4 weeks
Placebo
Placebo s.c weekly for 3 weeks then every 2 weeks
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Sall Research Medical Center
Artesia, California, United States
Novartis Investigative Site
Artesia, California, United States
Novartis Investigative Site
Beverly Hills, California, United States
Retina-Vitreous Assoc. Medical Group
Beverly Hills, California, United States
Emory University
Atlanta, Georgia, United States
Novartis Investigative Site
Atlanta, Georgia, United States
Novartis Investigative Site
Louisville, Kentucky, United States
University of Louisville Opthamology
Louisville, Kentucky, United States
Novartis Investigative Site
Baltimore, Maryland, United States
The Wilmer Eye Institute
Baltimore, Maryland, United States
Massachusets Eye Research and Surgery Institution (MERSI)
Cambridge, Massachusetts, United States
Novartis Investigative Site
Cambridge, Massachusetts, United States
Novartis Investigative Site
Teaneck, New Jersey, United States
The Cornea and Laser Institute and UMDNJ
Teaneck, New Jersey, United States
Charlotte Eye, Ear, Nose, and Throat Associates
Belmont, North Carolina, United States
Novartis Investigative Site
Charlotte, North Carolina, United States
Novartis Investigative Site
Portland, Oregon, United States
OHSU, Casey Eye Institute
Portland, Oregon, United States
Novartis Investigative Site
Arlington, Texas, United States
Texas Retina Associates
Arlington, Texas, United States
Houston Eye Associates
Houston, Texas, United States
Novartis Investigative Site
Houston, Texas, United States
University of Washington
Seattle, Washington, United States
Novartis Investigative Site
Seattle, Washington, United States
Novartis Investigative Site
São Paulo, São Paulo, Brazil
Novartis Investigative Site
São Paulo, São Paulo, Brazil
Novartis Investigative Site
Rio de Janeiro, , Brazil
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São Paulo, , Brazil
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São Paulo, , Brazil
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Berlin, , Germany
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Chemnitz, , Germany
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Dessau, , Germany
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Dessau, , Germany
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Essen, , Germany
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Essen, , Germany
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Freiburg im Breisgau, , Germany
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Kiel, , Germany
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Münster, , Germany
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Tübingen, , Germany
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Bangalore, Karnataka, India
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Chennai, Tamil Nadu, India
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Madurai, Tamil Nadu, India
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Hyderabad, Telangana, India
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Chandigarh, , India
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Chennai, , India
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Coimbatore, , India
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Kolkata, , India
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Madurai, , India
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New Delhi, , India
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Jerusalem, , Israel
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Petah Tikva, , Israel
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Ramat Gan, , Israel
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Tel Aviv, , Israel
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Milan, MI, Italy
Novartis Investigative Site
Parma, PR, Italy
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Roma, RM, Italy
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Ancona, , Italy
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Milan, , Italy
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Milan, , Italy
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Parma, , Italy
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Roma, , Italy
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Barcelona, Catalonia, Spain
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Barcelona, Catalonia, Spain
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Santiago de Compostela, Galicia, Spain
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Madrid, Madrid, Spain
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Valencia, Valencia, Spain
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Barakaldo, Vizcaya, Spain
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Barakaldo, , Spain
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Barcelona, , Spain
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Barcelona, , Spain
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Madrid, , Spain
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Santiago de Compostela, , Spain
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Valencia, , Spain
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Valencia, , Spain
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Lausanne, CHE, Switzerland
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Lausanne, Switzerland, Switzerland
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Zurich, Switzerland, Switzerland
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Bern, , Switzerland
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Bern, , Switzerland
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Lausanne, , Switzerland
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Lausanne, , Switzerland
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Lucerne, , Switzerland
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Sankt Gallen, , Switzerland
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Zurich, , Switzerland
Novartis Investigative Site
Ankara, , Turkey (Türkiye)
Novartis Investigative Site
Fatih / Istanbul, , Turkey (Türkiye)
Novartis Investigative Site
Istanbul, , Turkey (Türkiye)
Novartis Investigative Site
Birmingham, , United Kingdom
Novartis Investigative Site
Bristol, , United Kingdom
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Bristol, , United Kingdom
Novartis Investigative Site
Liverpool, , United Kingdom
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London, , United Kingdom
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London, , United Kingdom
Novartis Investigative Site
York, , United Kingdom
Countries
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References
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Dick AD, Tugal-Tutkun I, Foster S, Zierhut M, Melissa Liew SH, Bezlyak V, Androudi S. Secukinumab in the treatment of noninfectious uveitis: results of three randomized, controlled clinical trials. Ophthalmology. 2013 Apr;120(4):777-87. doi: 10.1016/j.ophtha.2012.09.040. Epub 2013 Jan 3.
Other Identifiers
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2009-014835-19
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CAIN457C2301
Identifier Type: -
Identifier Source: org_study_id
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