Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
76 participants
INTERVENTIONAL
2008-06-30
2013-09-30
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
DOUBLE
Study Groups
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Cohort 1
Participants were administered with AIN457 (Sp2/0derived) 10 milligrams per kilogram (mg/kg) intravenous (i.v.) dose on Day 1 and Day 22.
AIN457
AIN457 subcutaneous dose
Cohort 2
Participants were administered with AIN457 (Sp2/0 or Chinese hamster ovary cell (CHO) derived) 10 mg/kg, (CHO derived) 3 mg/kg or (CHO derived) 1 mg/kg i.v. dose on Day 1 and if needed a second dose of AIN457 10 mg/kg i.v. dose either on Day 15 or Day 22. 3 participants from cohort 1 rolled on into this cohort.
AIN457
AIN457 subcutaneous dose
Cohort 3
Participants were administered with AIN457 10 mg/kg i.v. dose on Day 1 and Day 22.
AIN 457
AIN457 low dose (i.v)
Cohort 4
Extension period: Participants were administered with AIN457 10 mg/kg, i.v. (with or without a short course of corticosteroids) once a flare had occurred, or periodically at a frequency of not more than once per month at the discretion of the investigator.
AIN 457
AIN457 low dose (i.v)
Cohort 5
Participants were administered with AIN457 30 mg/kg single i.v. dose. A second dose was given when all 4 participants completed at least 29 days, and the 30 mg/kg dose was well tolerated by all.
AIN457
AIN457 high dose (i.v)
Cohort 6 Arm 1
Participants were administered with AIN457 300 mg subcutaneously (s.c.) and saline i.v. infusion every two weeks (Days 1, 15, 29, and 43).
AIN457
AIN457 high dose (i.v)
Cohort 6 Arm 2
Participants were administered with AIN457 10 mg/kg i.v. and s.c. saline injections every two weeks (Days 1, 15, 29, and 43).
AIN 457
AIN457 low dose (i.v)
Cohort 6 Arm 3
Participants were administered with AIN457 30 mg/kg i.v. and s.c. saline injections every 4 weeks (Days 1 and 29) and saline i.v. infusions and saline s.c. injections on Days 15 and 43 to maintain masking of treatment groups.
AIN457
AIN457 high dose (i.v)
Interventions
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AIN457
AIN457 subcutaneous dose
AIN 457
AIN457 low dose (i.v)
AIN457
AIN457 high dose (i.v)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Intermediate uveitis, posterior uveitis, or panuveitis must be sufficiently severe that systemic immunosuppression is indicated.
Exclusion Criteria
* Weight must not be greater that 120kg.
18 Years
75 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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Novartis Investigative Site
Beverly Hills, California, United States
Novartis Investigative Site
Los Angeles, California, United States
Novartis Investigative Site
Sacramento, California, United States
Novartis Investigative Site
Denver, Colorado, United States
Novartis Investigative Site
Golden, Colorado, United States
Novartis Investigative Site
Littleton, Colorado, United States
Novartis Investigative Site
Atlanta, Georgia, United States
Novartis Investigative Site
Baltimore, Maryland, United States
Novartis Investigative Site
Baltimore, Maryland, United States
Novartis Investigative Site
Cambridge, Massachusetts, United States
Novartis Investigative Site
Kansas City, Missouri, United States
Novartis Investigative Site
Teaneck, New Jersey, United States
Novartis Investigative Site
New York, New York, United States
Novartis Investigative Site
Slingerlands, New York, United States
Novartis Investigative Site
Durham, North Carolina, United States
Novartis Investigative Site
Cleveland, Ohio, United States
Novartis Investigative Site
Spartanburg, South Carolina, United States
Novartis Investigative Site
Arlington, Texas, United States
Novartis Investigative Site
Austin, Texas, United States
Novartis Investigative Site
Houston, Texas, United States
Novartis Investigative Site
Berlin, , Germany
Novartis Investigative Site
Heidelberg, , Germany
Novartis Investigative Site
Tübingen, , Germany
Countries
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References
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Letko E, Yeh S, Foster CS, Pleyer U, Brigell M, Grosskreutz CL; AIN457A2208 Study Group. Efficacy and safety of intravenous secukinumab in noninfectious uveitis requiring steroid-sparing immunosuppressive therapy. Ophthalmology. 2015 May;122(5):939-48. doi: 10.1016/j.ophtha.2014.12.033. Epub 2015 Jan 29.
Hueber W, Patel DD, Dryja T, Wright AM, Koroleva I, Bruin G, Antoni C, Draelos Z, Gold MH; Psoriasis Study Group; Durez P, Tak PP, Gomez-Reino JJ; Rheumatoid Arthritis Study Group; Foster CS, Kim RY, Samson CM, Falk NS, Chu DS, Callanan D, Nguyen QD; Uveitis Study Group; Rose K, Haider A, Di Padova F. Effects of AIN457, a fully human antibody to interleukin-17A, on psoriasis, rheumatoid arthritis, and uveitis. Sci Transl Med. 2010 Oct 6;2(52):52ra72. doi: 10.1126/scitranslmed.3001107.
Other Identifiers
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2011-001243-67
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CAIN457A2208
Identifier Type: -
Identifier Source: org_study_id
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