Safety and Efficacy Study of Gevokizumab to Treat Non-infectious Uveitis Controlled With Systemic Treatment
NCT ID: NCT01747538
Last Updated: 2016-07-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
281 participants
INTERVENTIONAL
2012-10-31
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
QUADRUPLE
Study Groups
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Placebo
Placebo
Solution for subcutaneous injection
Dose 1 gevokizumab
Dose 1 gevokizumab
Solution for subcutaneous injection
Dose 2 gevokizumab
Dose 2 gevokizumab
Solution for subcutaneous injection
Interventions
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Placebo
Solution for subcutaneous injection
Dose 1 gevokizumab
Solution for subcutaneous injection
Dose 2 gevokizumab
Solution for subcutaneous injection
Eligibility Criteria
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Inclusion Criteria
* Controlled uveitic disease in both eyes
* Stable dose of oral corticosteroids in combination with selected stable immunosuppressive therapy
* Effective contraceptive measures
Exclusion Criteria
* Isolated anterior uveitis
* Contraindication to mydriatics
* Active tuberculosis disease
* History of allergic or anaphylactic reactions to monoclonal antibodies
* History of recurrent infection or predisposition to infection; active ocular infection
* Pregnant or nursing women
18 Years
ALL
No
Sponsors
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Institut de Recherches Internationales Servier
OTHER
XOMA (US) LLC
INDUSTRY
Responsible Party
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Locations
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Chandler, Arizona, United States
Phoenix, Arizona, United States
Beverly Hills, California, United States
Los Angeles, California, United States
Redlands, California, United States
Sacramento, California, United States
San Luis Obispo, California, United States
Santa Ana, California, United States
Victorville, California, United States
Golden, Colorado, United States
Littleton, Colorado, United States
Bridgeport, Connecticut, United States
Washington D.C., District of Columbia, United States
Lakeland, Florida, United States
St. Petersburg, Florida, United States
Tampa, Florida, United States
Atlanta, Georgia, United States
Chicago, Illinois, United States
Indianapolis, Indiana, United States
Iowa City, Iowa, United States
Ellsworth, Maine, United States
Baltimore, Maryland, United States
Cambridge, Massachusetts, United States
Waltham, Massachusetts, United States
Detroit, Michigan, United States
Jackson, Michigan, United States
Royal Oak, Michigan, United States
Rochester, Minnesota, United States
St Louis, Missouri, United States
Omaha, Nebraska, United States
Bloomfield, New Jersey, United States
Palisades Park, New Jersey, United States
Teaneck, New Jersey, United States
Belmont, North Carolina, United States
Charlotte, North Carolina, United States
Winston-Salem, North Carolina, United States
Fargo, North Dakota, United States
Beachwood, Ohio, United States
Cleveland, Ohio, United States
Middleburg Heights, Ohio, United States
Ashland, Oregon, United States
Philadelphia, Pennsylvania, United States
Knoxville, Tennessee, United States
Memphis, Tennessee, United States
Austin, Texas, United States
Dallas, Texas, United States
Houston, Texas, United States
Mission, Texas, United States
San Antonio, Texas, United States
Salt Lake City, Utah, United States
Norfolk, Virginia, United States
Olivos, Buenos Aires, Argentina
Rosaria, Santa Fe Province, Argentina
Buenos Aires, , Argentina
Yerevan, , Armenia
Sydney, New South Wales, Australia
East Melbourne, Victoria, Australia
Nedlands, Western Australia, Australia
Darlinghurst, New South Wales, , Australia
Belo Horizonte, Minas Gerais, Brazil
Rio de Janeiro, , Brazil
São Paulo, , Brazil
Ottawa, Ontario, Canada
Montreal, Quebec, Canada
Beijing, , China
Chongqing, , China
Hong Kong, , China
Lyon, , France
Nantes, , France
Paris, , France
Berlin, , Germany
Chemnitz, , Germany
Heidelberg, , Germany
Münster, , Germany
Tüebingen, , Germany
Mezourlo, Larissa, , Greece
Jerusalem, , Israel
Petoch Tikvah, , Israel
Tel Aviv, , Israel
Ancona, Marche, , Italy
Genova, , Italy
Milan, , Italy
Padua, , Italy
Romagna, , Italy
Distrito Federal, , Mexico
Mexico City, , Mexico
Nuevo León, , Mexico
Tijuana, , Mexico
Gdansk, , Poland
Katowice, , Poland
Lublin, , Poland
Warsaw, , Poland
Braga, , Portugal
Coimbra, , Portugal
Lisbon, , Portugal
Khabarovsk, , Russia
Novosibirsk, , Russia
Saint Petersburg, , Russia
Durban, , South Africa
Johannesburg, Gauteng, , South Africa
Barcelona, , Spain
Granada, , Spain
Madrid, , Spain
Málaga, , Spain
Taïpeï City, , Taiwan
Taoyuan District, , Taiwan
Monastir, , Tunisia
Ankara, , Turkey (Türkiye)
Cerrahpasa, Istanbul, , Turkey (Türkiye)
Faith, Istanbul, , Turkey (Türkiye)
Sunderland, Tyne and Wear, United Kingdom
Bristol, , United Kingdom
Liverpool, , United Kingdom
London, , United Kingdom
Countries
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Other Identifiers
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2012-001609-25
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
U1111-1135-1462
Identifier Type: OTHER
Identifier Source: secondary_id
X052131/CL3-78989-006
Identifier Type: -
Identifier Source: org_study_id
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