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

Results pending

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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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

281 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Brief Summary

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The purpose of this study is to evaluate the efficacy of gevokizumab in reducing the risk of recurrent uveitic disease in subjects with non-infectious uveitis whose disease is currently controlled with systemic treatment.

Detailed Description

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Conditions

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Uveitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Solution for subcutaneous injection

Dose 1 gevokizumab

Group Type EXPERIMENTAL

Dose 1 gevokizumab

Intervention Type DRUG

Solution for subcutaneous injection

Dose 2 gevokizumab

Group Type EXPERIMENTAL

Dose 2 gevokizumab

Intervention Type DRUG

Solution for subcutaneous injection

Interventions

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Placebo

Solution for subcutaneous injection

Intervention Type DRUG

Dose 1 gevokizumab

Solution for subcutaneous injection

Intervention Type DRUG

Dose 2 gevokizumab

Solution for subcutaneous injection

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of non-infectious intermediate, posterior, or pan- uveitis in at least one eye
* Controlled uveitic disease in both eyes
* Stable dose of oral corticosteroids in combination with selected stable immunosuppressive therapy
* Effective contraceptive measures

Exclusion Criteria

* Infectious uveitis and masquerade syndromes
* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institut de Recherches Internationales Servier

OTHER

Sponsor Role collaborator

XOMA (US) LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Chandler, Arizona, United States

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Phoenix, Arizona, United States

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Beverly Hills, California, United States

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Los Angeles, California, United States

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Redlands, California, United States

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Sacramento, California, United States

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San Luis Obispo, California, United States

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Santa Ana, California, United States

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Victorville, California, United States

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Golden, Colorado, United States

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Littleton, Colorado, United States

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Bridgeport, Connecticut, United States

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Washington D.C., District of Columbia, United States

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Lakeland, Florida, United States

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St. Petersburg, Florida, United States

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Tampa, Florida, United States

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Atlanta, Georgia, United States

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Chicago, Illinois, United States

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Indianapolis, Indiana, United States

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Iowa City, Iowa, United States

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Ellsworth, Maine, United States

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Baltimore, Maryland, United States

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Cambridge, Massachusetts, United States

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Waltham, Massachusetts, United States

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Detroit, Michigan, United States

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Jackson, Michigan, United States

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Royal Oak, Michigan, United States

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Rochester, Minnesota, United States

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St Louis, Missouri, United States

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Omaha, Nebraska, United States

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Bloomfield, New Jersey, United States

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Palisades Park, New Jersey, United States

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Teaneck, New Jersey, United States

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Belmont, North Carolina, United States

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Charlotte, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Fargo, North Dakota, United States

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Beachwood, Ohio, United States

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Cleveland, Ohio, United States

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Middleburg Heights, Ohio, United States

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Ashland, Oregon, United States

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Philadelphia, Pennsylvania, United States

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Knoxville, Tennessee, United States

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Memphis, Tennessee, United States

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Austin, Texas, United States

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Dallas, Texas, United States

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Houston, Texas, United States

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Mission, Texas, United States

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San Antonio, Texas, United States

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Salt Lake City, Utah, United States

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Norfolk, Virginia, United States

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Olivos, Buenos Aires, Argentina

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Rosaria, Santa Fe Province, Argentina

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Buenos Aires, , Argentina

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Yerevan, , Armenia

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Sydney, New South Wales, Australia

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East Melbourne, Victoria, Australia

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Nedlands, Western Australia, Australia

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Darlinghurst, New South Wales, , Australia

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Belo Horizonte, Minas Gerais, Brazil

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Rio de Janeiro, , Brazil

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São Paulo, , Brazil

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Ottawa, Ontario, Canada

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Montreal, Quebec, Canada

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Beijing, , China

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Chongqing, , China

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Hong Kong, , China

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Lyon, , France

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Nantes, , France

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Paris, , France

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Berlin, , Germany

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Chemnitz, , Germany

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Heidelberg, , Germany

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Münster, , Germany

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Tüebingen, , Germany

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Mezourlo, Larissa, , Greece

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Jerusalem, , Israel

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Petoch Tikvah, , Israel

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Tel Aviv, , Israel

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Ancona, Marche, , Italy

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Genova, , Italy

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Milan, , Italy

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Padua, , Italy

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Romagna, , Italy

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Distrito Federal, , Mexico

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Mexico City, , Mexico

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Nuevo León, , Mexico

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Tijuana, , Mexico

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Gdansk, , Poland

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Katowice, , Poland

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Lublin, , Poland

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Warsaw, , Poland

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Braga, , Portugal

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Coimbra, , Portugal

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Lisbon, , Portugal

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Khabarovsk, , Russia

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Novosibirsk, , Russia

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Saint Petersburg, , Russia

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Durban, , South Africa

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Johannesburg, Gauteng, , South Africa

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Barcelona, , Spain

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Granada, , Spain

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Madrid, , Spain

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Málaga, , Spain

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Taïpeï City, , Taiwan

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Taoyuan District, , Taiwan

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Monastir, , Tunisia

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Ankara, , Turkey (Türkiye)

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Cerrahpasa, Istanbul, , Turkey (Türkiye)

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Faith, Istanbul, , Turkey (Türkiye)

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Sunderland, Tyne and Wear, United Kingdom

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Bristol, , United Kingdom

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Liverpool, , United Kingdom

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London, , United Kingdom

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Countries

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United States Argentina Armenia Australia Brazil Canada China France Germany Greece Israel Italy Mexico Poland Portugal Russia South Africa Spain Taiwan Tunisia Turkey (Türkiye) United Kingdom

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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